The effect of robot-assisted versus standard training on motor function following subacute rehabilitation after ischemic stroke - protocol for a randomised controlled trial nested in a prospective cohort (RoboRehab).

BACKGROUND: Body weight unloaded treadmill training has shown limited efficacy in further improving functional capacity after subacute rehabilitation of ischemic stroke patients. Dynamic robot assisted bodyweight unloading is a novel technology that may provide superior training stimuli and continued functional improvements in individuals with residual impairments in the chronic phase after the ischemic insult. The aim of the present study is to investigate the effect of dynamic robot-assisted versus standard training, initiated 6 months post-stroke, on motor function, physical function, fatigue, and quality of life in stroke-affected individuals still suffering from moderate-to-severe disabilities after subacute rehabilitation. METHODS: Stroke-affected individuals with moderate to severe disabilities will be recruited into a prospective cohort with measurements at 3-, 6-, 12- and 18-months post-stroke. A randomised controlled trial (RCT) will be nested in the prospective cohort with measurements pre-intervention (Pre), post-intervention (Post) and at follow-up 6 months following post-intervention testing. The present RCT will be conducted as a multicentre parallel-group superiority of intervention study with assessor-blinding and a stratified block randomisation design. Following pre-intervention testing, participants in the RCT study will be randomised into robot-assisted training (intervention) or standard training (active control). Participants in both groups will train 1:1 with a physiotherapist two times a week for 6 months (groups are matched for time allocated to training). The primary outcome is the between-group difference in change score of Fugl-Meyer Lower Extremity Assessment from pre-post intervention on the intention-to-treat population. A per-protocol analysis will be conducted analysing the differences in change scores of the participants demonstrating acceptable adherence. A priori sample size calculation allowing the detection of the minimally clinically important between-group difference of 6 points in the primary outcome (standard deviation 6 point, α = 5% and ß = 80%) resulted in 34 study participants. Allowing for dropout the study will include 40 participants in total. DISCUSSION: For stroke-affected individuals still suffering from moderate to severe disabilities following subacute standard rehabilitation, training interventions based on dynamic robot-assisted body weight unloading may facilitate an appropriate intensity, volume and task-specificity in training leading to superior functional recovery compared to training without the use of body weight unloading. TRIAL REGISTRATION: ClinicalTrials.gov. NCT06273475. TRIAL STATUS: Recruiting. Trial identifier: NCT06273475. Registry name: ClinicalTrials.gov. Date of registration on ClinicalTrials.gov: 22/02/2024.

Recreational screen time behaviour among ambulatory children and adolescents diagnosed with cerebral palsy: A cross-sectional analysis.

AIM: To describe the recreational screen time behaviour of 8-16-year-olds diagnosed with cerebral palsy (CP) and explore associations between health-related quality of life, sleep duration and physical activity behaviour versus screen time. METHODS: This cross-sectional study used proxy-reported questionnaire data of 381 ambulatory (with or without assistance) 8-16-year-olds diagnosed with CP corresponding to Gross Motor Function Classification System (GMFCS) levels I-III. Descriptive statistics were used to report age, sex and the GMFCS level. The potential associations of health-related quality of life, physical activity behaviour and sleep duration (dependent variables) versus screen time (independent variable) were determined using multiple linear regression. Health-related quality of life was evaluated using the Pediatric Quality of Life Inventory, including seven dimensions: Daily Activities; School Activities; Movement and Balance; Pain and Hurt; Fatigue; Eating Activities; and Speech and Communication. RESULTS: The participants spent a median screen time of 3.9 h daily. The boys spent a longer screen time during weekends than the girls (p = 0.003). Boys spent more time on games (p < 0.001), whereas girls spent more time on social media and video calls (p < 0.001). Increasing age (p < 0.001) was associated with increased screen time but did not differ between the GMFCS levels. Sleep duration, perceived fatigue and perceived movement and balance correlated negatively with screen time. CONCLUSION: This study sheds light on the recreational screen time habits of ambulatory children and adolescents diagnosed with CP. Further investigation into the observed associations is warranted to investigate potential causation and relationships between sleep behaviour, quality of life and screen time behaviour.

How best to support parents in the management of standing frame usage in home settings: A mixed methods study.

BACKGROUND: An improved understanding of the current practice of standing frame use may have implications for supporting parents in managing standing frames. We aimed to investigate how parents of children with cerebral palsy perceive and manage standing frame use in home settings. METHODS: We conducted a mixed methods study with an explanatory sequential design, first collecting and analysing quantitative questionnaire data and then using these results to inform a qualitative follow-up phase to explain them. The questionnaire was answered by 103 parents of children with cerebral palsy across five countries, Denmark, Norway, Great Britain, Canada and the United States, and 12 Danish families participated in the subsequent interviews. A descriptive analysis was conducted using the questionnaire data. The qualitative data were analysed using a directed content analysis, enabling integration of the quantitative and qualitative data. RESULTS: The quantitative analysis showed that 89% of the parents felt confident with their child's standing frame, and 82% felt they had sufficient knowledge about how their child's standing frame could/should be used. However, the qualitative analysis showed that even when feeling confident, the parents experienced insecurity regarding whether their child was positioned correctly, and being responsible for positioning was challenging. CONCLUSION: Our study implies a need for providing educational materials to assist the parents in ensuring optimal positioning of their child in the standing frame to decrease insecurity. Additionally, our study suggests a need to provide more thorough information about the benefits of using a standing frame and ensure alignment of expectations in relation to the child's prognosis of functional independence.

Performance Measures and Plasma Biomarker Levels in Patients with Multiple Sclerosis after 14 Days of Fampridine Treatment: An Explorative Study.

Peripheral cytokine levels may serve as biomarkers for treatment response and disease monitoring in patients with multiple sclerosis (pwMS). The objectives were to assess changes in plasma biomarkers in PwMS after 14 days of fampridine treatment and to explore correlations between changes in performance measures and plasma biomarkers. We included 27 PwMS, 14 women and 13 men, aged 52.0 ± 11.6 years, with a disease duration of 17 ± 8.5 years, and an Expanded Disability Status Scale of 6 [IQR 5.0/6.5]. Gait and hand function were assessed using performance tests completed prior to fampridine and after 14 days of treatment. Venous blood was obtained, and chemiluminescence analysis conducted to assess plasma cytokines and neurodegenerative markers. All performance measures demonstrated improvements. Biomarkers showed decreased tumor necrosis factor (TNF) receptor-2 levels. Associations were found between change scores in (i) Six Spot Step Test and Interleukin (IL)-2, IL-8, and IL-17 levels; (ii) timed 25-foot walk and interferon-γ, IL-2, IL-8, TNF-α, and neurofilament light levels, and (iii) 12-Item Multiple Sclerosis Walking Scale and IL-17 levels. The associations may reflect increased MS-related inflammatory activity rather than a fampridine-induced response or that a higher level of inflammation induces a better response to fampridine.

Hip survival after periacetabular osteotomy in patients with acetabular dysplasia, acetabular retroversion, congenital dislocation of the hip, or Legg-Calvé-Perthes disease: a cohort study on 1,501 hips.

BACKGROUND AND PURPOSE: Previous studies on hip survival following periacetabular osteotomy (PAO) have reported isolated data for the treatment of 1 underlying condition, making comparison between patient groups difficult. We report the hip survival after PAO in patients with acetabular dysplasia (AD), acetabular retroversion (AR), congenital dislocation of the hip (CDH), and Legg-Calvé-Perthes disease (LCPD) with total hip arthroplasty (THA) as primary endpoint and secondarily the risk of subsequent hip-related operations other than THA. PATIENTS AND METHODS: From 1997 to December 2021, 1,501 hips (1,203 patients) underwent PAO in a single center (Odense University Hospital). We identified conversions to THA and other subsequent hip-related operations through patient files and the Danish National Patient Registry (DNPR). RESULTS: 123 (8.2%) of the total cohort of 1,501 hips were converted to THA within the study period. The overall Kaplan-Meier hip survival rate was 71% (95% confidence interval [CI] 61-79) at 24 years with a mean follow-up of 7.6 years (range 0.02-25). The individual Kaplan-Meier hip survival rates at 15 years were 81% (CI 76-86) for AD, 94% (CI 91-96) for AR, 84% (CI 66-93) for CDH, and 66% (CI 49-79) for LCPD. In total, the overall risk of additional hip-related operations was 48% (of which 92% were screw removal). CONCLUSION: Encouragingly, 71% of hips were preserved 24 years after PAO. We found that AR patients had the highest (94%) PAO survivorship at 15 years compared with the other underlying hip conditions. Almost half of PAO patients may undergo later additional surgery, of which screw removal is the primary intervention. Overall long-term survival, risk factors for conversion to THA, and risk of additional surgery are relevant information for shared decision-making.

Predictors of Physical Activity Levels in Ambulant/Semiambulant Children and Adolescents With Cerebral Palsy: A Clinical Cohort Study.

Children and adolescents with cerebral palsy (CP) show a reduced physical activity (PA) level compared with their typically developed peers. This study aimed to identify potential predictors of objectively evaluated habitual PA using data from a national clinical registry-the Cerebral Palsy Follow-Up Program (CPFP)-and proxy-reported questionnaires. Data from the CPFP database showed that female sex was associated with a lower PA level. Additional questionnaire data revealed age, popliteal angle limitation, Pediatric Outcomes Data Collection Instrument-Sports and Physical Functioning Scale score, screen time, Functional Mobility Scale score at 50 m, and fatigue as predictors. The proposed models can be used for the prediction and early detection of the PA level and consequently for the potential improvement among ambulant/semiambulant individuals with CP. Further research should investigate the predictive impact of personal, social, and environmental factors on the PA level and the gap in PA levels between girls and boys.

Physical impairments among adults in Denmark: a register-based study.

BACKGROUND: Knowledge of the prevalence and socio-demographic characteristics of physical impairments is limited. This study aimed to determine the prevalence of physical impairments among adults in Denmark, both in total and according to nine common diagnostic subgroups, describe the socio-demographic and socio-economic profile, and compare the data with those of the general adult population. METHODS: This descriptive, cross-sectional, register-based study evaluated the general socio-demographic and socio-economic variables, including sex, age, geographical region, origin, educational level, occupation, marital status, and disability level, of adults with physical impairments extracted by diagnosis from the Danish National Patient Register and Statistics Denmark by 31 December 2018. These data were compared with those of the general adult population in Denmark extracted from Statistics Denmark by January 2019. RESULTS: In total, 606,857 adults with physical impairments were identified. Of the nine selected diagnoses, osteoarthritis (69.4%) was the most prevalent, followed by acquired brain injury (29.0%), rheumatoid arthritis (6.7%), multiple sclerosis (2.6%), spinal cord injury (1.5%), cerebral palsy (1.2%), amputation (0.7%), muscular dystrophy (0.5%), and poliomyelitis (< 0.1%). There were large variations in the socio-demographic and socio-economic profile between the nine diagnostic subgroups. The adults with physical impairments were more often women, were older, were less often immigrants and employed adults, had a lower educational level, and were more commonly married than the general adult population. Only the geographical region did not differ. CONCLUSION: The nine subgroups with diagnoses related to the musculoskeletal system represent 13% of the adult Danish population. The socio-demographic and socio-economic profile varied largely between the nine diagnostic subgroups, and almost all variables differed significantly between adults with physical impairments and the general adult population in Denmark. These findings reveal patterns and trends on socio-demographic and socio-economic variables essential for future planning at a societal level, including the healthcare and social sectors.

Effectiveness of instrumented gait analysis in interdisciplinary interventions on parents' perception of family-centered service and on gross motor function in children with cerebral palsy: a randomized controlled trial.

BACKGROUND: Children with cerebral palsy often exhibit an altered gait pattern; however, it is uncertain whether the use of an instrumented gait analysis in interdisciplinary interventions affects the perceived experience of family-centered service (FCS) and/or gross motor function. The aim of this study is to investigate whether individually tailored interdisciplinary interventions, based on an instrumented gait analysis report, has a superior effectiveness on perceived FCS and gross motor function in children with cerebral palsy, compared to 'care as usual' without the use of instrumented gait analysis. Furthermore, to investigate potential associations between perceived FCS and gross motor function improvement with the goal of improving future therapy on gross motor function. METHOD: This is a sequel analysis on tertiary outcome measures from a prospective, single blind, randomized, parallel group study including two groups of 30 children aged 5-8 years with spastic cerebral palsy at Gross Motor Function Classification System levels I-II (n = 60). The intervention group underwent a three-dimensional gait analysis, from which a clinical report was written with recommendations on interdisciplinary interventions, such as physical therapy, orthopedic surgery, orthotics or spasticity management. To assess effectiveness on perceived FCS and gross motor function, at baseline, 26 weeks and 52 weeks, the five domains in the Measure of Processes of Care (MPOC-20) (Enabling and partnership, Providing general information, Providing specific information about the child, Respectful and supportive service, and Coordinated and comprehensive care) and the Gross Motor Function Measurement (GMFM-66) were used as outcome measures. RESULTS: No significant differences in between-group change scores in any of the five MPOC-20 domains were observed (p = 0.40-0.97). In favor of the intervention group a significantly higher between-group change score in GMFM-66 (mean difference: 3.05 [95%CI: 1.12-4.98], p = 0.003) after 52 weeks was observed. CONCLUSION: The addition of an instrumented gait analysis report to 'care as usual' did not improve the parents' perceptions of FCS in treatment of children with cerebral palsy. However, superior improvement in the GMFM-66 was observed in the intervention group, suggesting meaningful gross motor function improvement. TRIAL REGISTRATION: Clinical Trials, NCT02160457 . Registered June 10th 2014.

Gait analysis for individually tailored interdisciplinary interventions in children with cerebral palsy: a randomized controlled trial.

AIM: To test the hypothesis that improvements in gait and function following individualized interdisciplinary interventions consisting of physical therapy, orthotics, spasticity management, and orthopaedic surgery using instrumented gait analysis are superior to 'usual care' in children with cerebral palsy (CP). METHOD: This was a prospective, single-blind, parallel-group, randomized controlled trial investigating the effectiveness of interventions based on the use of gait analysis. Primary outcome was gait (Gait Deviation Index) and secondary outcomes were walking and patient-reported outcome measures of function, disability, and health-related quality of life. Follow-ups were done at 26 weeks (questionnaires) and at the primary end point of 52 weeks (all outcomes). RESULTS: Sixty participants with CP (39 males, 21 females, mean age 6y 10mo, standard deviation 1y 3mo, range 5y-9y 1mo) in Gross Motor Function Classification System levels I or II, were randomized to interventions with or without gait analysis. No significant or clinically relevant between-group differences in change scores of the primary or secondary outcomes were found. The recommended categories of interventions were dominated by non-surgical interventions and were applied in 36% to 86% of the participants. INTERPRETATION: Interventions using gait analysis were not superior to 'usual care' on gait, walking, or patient-reported outcomes in a sample of relatively young and independently walking children with CP not expected to need surgery. WHAT THIS PAPER ADDS: Gait analysis in children with cerebral palsy in Gross Motor Function Classification System levels I or II recommends interdisciplinary interventions. Compliance to interventions recommended after gait analysis was low. No statistically significant advantages were identified for the intervention group versus the control group.

ANÁLISIS DE MARCHA PARA LA INTERVENCIÓN INTERDISCIPLINARIA ADAPTADA INDIVIDUALMENTE EN NIÑOS CON PARÁLISIS CEREBRAL: ENSAYO CONTROLADO RANDOMIZADO: OBJETIVO: Comprobar la hipótesis que las mejoras en la marcha y la función luego de las intervenciones interdisciplinarias individualizadas de terapia física, ortésis, tratamiento antiespástico, y cirugía ortopédica son superiores que "tratamiento convencional" en parálisis cerebral (PC) utilizando un análisis de marcha instrumentada METODO: Este fue un ensayo randomizado controlado, prospectivo, ciego, con grupo paralelo que investigó la efectividad de intervenciones basada en el uso de análisis de marcha. El resultado primario fue la marcha (Índice de Desviación de la Marcha) y los resultados secundarios fueron el paso y los resultados reportados por los pacientes de función, discapacidad y calidad de vida relacionada a la salud. Los seguimientos se realizaron a las 26 semanas (cuestionarios) y el punto de fin primario de 52 semanas (todos los resultados). RESULTADOS: Sesenta participantes con PC (39 masculinos, 21 femeninos, edad media de 6 años 10 meses, desviación estándar de 1 años y 3 meses, rango 5 años 0 meses- 9 años y 1 mes) con niveles de GMFCS I o II, fueron asignados al azar intervenciones con y sin análisis de marcha. No se encontraron diferencias significativas o clínicamente relevantes entre los grupos en cuanto a los cambios de los resultados primarios y secundarios. INTERPRETACION: Las intervenciones que usaron análisis de marcha no fueron superiores al tratamiento convencional sobre el paso, la marcha o resultados reportados por los pacientes en una muestra de niños con PC relativamente jóvenes y de marcha independiente que no se espera que necesiten cirugía.

ANÁLISE DE MARCHA PARA INTERVENÇÕES INDIVIDUALMENTE PLANEJADAS EM CRIANÇAS COM PARALISIA CEREBRAL: UM ENSAIO CONTROLADO RANDOMIZADO: OBJETIVO: Testar a hipótese de que melhoras na marcha e função após intervenções interdisciplinares individualizadas consistindo de fisioterapia, órteses, manejo da espasticidade, e cirurgia ortopédica usando análise de marcha instrumentalizada são superiors comparadas ao "cuidado usual" em crianças com paralisia cerebral (PC). MÉTODO: Este foi um estudo randomizado controlado prospectivo, único cego, com grupos paralelos, investigando a efetividade de intervenções baseadas no uso da análise de marcha. O desfecho primário foi a marcha (Índice de Desvio da Marcha) e os desfechos secundários foram o caminhar e medidas relatadas pelo paciente da função, incapacidade, e qualidade de vida relacionada à saúde. Acompanhamentos foram feitos com 26 semanas (questionários) e o encerramento primário foi 52 semanas (todos os resultados). RESULTADOS: Sessenta participantes com PC (39 do sexo masculino, 21 do sexo feminino, média de idade 6a 10 m, desvio padrão 1a 3 m, variação 5a 0 m- 9a 1 m) nos níveis do Sistema de Classificação da Função Motora Grossa (GMFCS) I ou II foram fandomizados para intervenções com ou sem análise de marcha. Nenhuma diferença significativa ou clinicamente relevante entre grupos nos escores de mudança dos desfechos primários e secundários foram encontradas. As categorias de intervenção recomendadas foram dominadas pelas intervenções não-cirúrgicas e foram aplicadas em 36% a 86% dos participantes. INTERPRETAÇÃO: Intervenções usando análise de marcha não foram superiores ao "cuidado usual" para a marcha, o caminhar, ou resultados reportados por pacientes em ma amostra de crianças com PC relativamente jovens e com deambulação indepente, para a qual não se espera a necessidade de cirurgia.

Musculoskeletal application and validation of speckle-tracking ultrasonography.

BACKGROUND: Diseased, injured, or dysfunctional skeletal muscles may demonstrate abnormal function and contractility. Currently, only few in vivo imaging techniques are able to characterize the contractile properties of muscle tissue. This study aimed to test the hypothesis that muscle strain can be tracked in two upper extremity skeletal muscles by speckle-tracking ultrasonography (STU) and correlates with isometric muscle contractions. METHODS: A convenience sample of 10 healthy, adult volunteers with normal shoulder function were tested. The 5 women and 5 men had a mean age of 45 years (range: 39-59 years) and BMI < 30. STU was applied to the supraspinatus (SS) and biceps brachii (BB) muscles using a M11 L-MHz linear transducer (frequency 8-15 MHz) hooked to a Vivid E 9TM ultrasound machine. Strain validation was performed by correlating peak strain against standardized sub-maximal, isometric load conditions of the two muscles (20-80% of maximal voluntary contraction) using a custom-built muscle dynamometer based on strain-gauge technique. Data were analyzed offline using the EchoPac speckle-tracking software and were blinded to the examiner. RESULTS: Intramuscular strain measured by STU in the SS and BB muscles showed moderate to strong correlations with external muscle load (SS: r = - 0.76, p < 0.0001 and BB: r = - 0.60, p < 0.0001). We found strain to vary from approximately 10-20% during increasing submaximal, isometric conditions. CONCLUSIONS: We demonstrate that STU can be applied on healthy skeletal musculature (SS and BB muscles). The observed correlations between strain and isometric contractions suggest a valid technique. However, the concept of measuring muscle strain non-invasively needs further investigation for validity, accuracy, responsiveness, and reliability before its therapeutic and research potential can be realized.

Threshold values of ankle dorsiflexion and gross motor function in 60 children with cerebral palsy.

Background and purpose - Threshold values defining 3 categories of passive range of motion are used in the Cerebral Palsy follow-Up Program to guide clinical decisions. The aim of this study was to investigate the threshold values by testing the hypothesis that passive range of motion in ankle dorsiflexion is associated with gross motor function and that function differs between the groups of participants in each category. Patients and methods - We analyzed data from 60 ambulatory children (aged 5-9 years) with spastic cerebral palsy. Outcomes were passive range of motion in ankle dorsiflexion with flexed and extended knee and gross motor function (Gait Deviation Index, Gait Variable Score of the ankle, peak dorsiflexion during gait, 1-minute walk, Gross Motor Function Measure, the Pediatric Quality of Life Inventory Cerebral Palsy Module, and Pediatric Outcomes Data Collection Instrument). Results - Significant (p < 0.05) and moderate correlations were documented for range of motion versus Gait Variable Score of the ankle (r = -0.37 and r = -0.37) and range of motion versus peak dorsiflexion (r = 0.49 and r = 0.55). Differences between the groups formed by the categories were shown for Gait Variable Score of the ankle and peak dorsiflexion (p < 0.05). No other significant correlations or differences between the categories were observed. Interpretation - The results suggest that threshold values for ankle dorsiflexion used in the Cerebral Palsy follow-Up Program are of limited clinical value in assessing overall gross motor function, but may be used to identify deviations in ankle-specific gait function.

Recovery of lower extremity muscle strength and functional performance in middle-aged patients undergoing arthroscopic partial meniscectomy.

PURPOSE: To investigate lower extremity muscle strength and functional performance before and after arthroscopic partial meniscectomy in middle-aged patients with degenerative meniscal tears. We hypothesized that patients would experience deficiencies in the affected leg at 3 months post-surgery, and that this deficiency would be normalized at 12 months following surgery. METHODS: Twenty-three patients (46 ± 6.5 years) meniscectomized in 2012 and 2013 were examined for knee extension, knee flexion, and hip abduction maximal isometric muscle strength (iMVC), rate of force development (RFD200), and knee function (single-leg hop for distance and single-leg knee bends in 30 s.) before surgery, 3 and 12 months after surgery. RESULTS: Functional performance, knee extension iMVC and RFD200 were impaired in the affected leg compared to the contralateral leg (p < 0.05) prior to surgery. A significant (Knee extension RFD200, p = 0.033) or borderline significant improvement was observed in the affected leg compared to the contralateral leg from before to 12 months after surgery in most variables (leg × time interaction, n.s.). CONCLUSION: Middle-aged patients undergoing surgery for degenerative medial meniscal tears show significant reductions in muscle strength, rapid force production, and functional performance in the leg undergoing surgery compared to the contralateral leg prior to surgery. These deficits in muscle strength and knee function were still present at 3 months post-surgery but were no longer observed at 12 months following surgery. LEVEL OF EVIDENCE: III.

Patient-reported outcome after total hip arthroplasty: comparison between lateral and posterior approach.

Background and purpose - Criticism of the lateral approach (LA) for hip arthroplasty is mainly based on the risk of poor patient-reported outcomes compared to the posterior approach (PA). However, there have been no controlled studies comparing patient-reported outcomes between them. In this randomized controlled trial, we tested the hypothesis that patient-reported outcomes are better in patients who have undergone total hip arthroplasty (THA) with PA than in those who have undergone THA with LA, 12 months postoperatively. Patients and methods - 80 patients with hip osteoarthritis (mean age 61 years) were randomized to THA using PA or the modified direct LA. We recorded outcome measures preoperatively and 3, 6, and 12 months postoperatively using the Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form (HOOS-PS) as the primary outcome. Secondary outcomes were HOOS-Pain, HOOS-Quality-Of-Life, EQ-5D, UCLA Activity Score, and limping. Results - We found no statistically significant difference in the improvements in HOOS-PS between the treatment groups at 12-month follow-up. All secondary outcomes showed similar results except for limping, where PA patients improved significantly more than LA patients. Interpretation - Contrary to our hypothesis, patients treated with PA did not improve more than patients treated with LA regarding physical function, pain, physical activity, and quality of life 12 months postoperatively. However, limping was more pronounced in the LA patients.

The use of instrumented gait analysis for individually tailored interdisciplinary interventions in children with cerebral palsy: a randomised controlled trial protocol.

BACKGROUND: Children with cerebral palsy (CP) often have an altered gait. Orthopaedic surgery, spasticity management, physical therapy and orthotics are used to improve the gait. Interventions are individually tailored and are planned on the basis of clinical examinations and standardised measurements to assess walking ('care as usual'). However, these measurements do not describe features in the gait that reflect underlying neuro-musculoskeletal impairments. This can be done with 3-dimensional instrumented gait analysis (IGA). The aim of this study is to test the hypothesis that improvements in gait following individually tailored interventions when IGA is used are superior to those following 'care as usual'. METHODS/DESIGN: A prospective, single blind, randomised, parallel group study will be conducted. Children aged 5 to 8 years with spastic CP, classified at Gross Motor Function Classification System levels I or II, will be included. The interventions under investigation are: 1) individually tailored interdisciplinary interventions based on the use of IGA, and 2) 'care as usual'. The primary outcome is gait measured by the Gait Deviation Index. Secondary outcome measures are: walking performance (1-min walk test) and patient-reported outcomes of functional mobility (Pediatric Evaluation of Disability Inventory), health-related quality of life (The Pediatric Quality of Life Inventory Cerebral Palsy Module) and overall health, pain and participation (The Pediatric Outcome Data Collection Instrument). The primary endpoint for assessing the outcome of the two interventions will be 52 weeks after start of intervention. A follow up will also be performed at 26 weeks; however, exclusively for the patient-reported outcomes. DISCUSSION: To our knowledge, this is the first randomised controlled trial comparing the effects of an individually tailored interdisciplinary intervention based on the use of IGA versus 'care as usual' in children with CP. Consequently, the study will provide novel evidence for the use of IGA. TRIAL REGISTRATION: ClinicalTrials.gov NCT02160457 . Registered June 2, 2014.

Quantifying Gait Quality in Patients with Large-Head and Conventional Total Hip Arthroplasty--A Prospective Cohort Study.

We used the Gait Deviation Index (GDI) as method to compare preoperative to postoperative gait changes after uncemented 50 mm (median) large-head and 28/32 mm total hip arthroplasty (THA). We also identified predictors of improvements in GDI. Gait analysis and patient-reported (WOMAC) data were recorded in 35 patients before, 2 and 6-months after treatment. Twenty age-matched adults provided normative gait data. Contrary to our hypothesis, patients who received large-head THA had less improvement in GDI compared with patients who received 28/32 mm THA. The preoperative GDI score was identified as a predictor of postoperative GDI improvement, while WOMAC, age, gender and walking speed were not. This study provides useful information for clinicians and rehabilitation specialists about gait improvement that can be expected after THA.

Postoperative effects of neuromuscular exercise prior to hip or knee arthroplasty: a randomised controlled trial.

OBJECTIVE: To investigate the postoperative efficacy of a supervised programme of neuromuscular exercise prior to hip or knee arthroplasty. METHODS: In this assessor-blinded randomised controlled trial, we included 165 patients scheduled for hip or knee arthroplasty due to severe osteoarthritis (OA). An 8-week preoperative neuromuscular supervised exercise programme was delivered twice a week for 1 h as adjunct treatment to the standard arthroplasty procedure and compared with the standard arthroplasty procedure alone. The primary outcome was self-reported physical function measured on the activities of daily living (ADL) subscale in the Hip disability and Osteoarthritis Outcome Score (HOOS) and the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaires for patients with hip and knee OA, respectively. Primary endpoint was 3 months after surgery. RESULTS: 165 patients randomised to the two groups were on average 67±8 years, 84 (51%) had hip OA and 92 (56%) were women. 153 patients (93%) underwent planned surgery and were evaluated postoperatively. There was no statistically significant difference in effects between hip or knee patients (p=0.7370). Three months postoperatively, no difference was found between groups for ADL (4.4, 95% CI -0.8 to 9.5) or pain (4.5, 95% CI -0.8 to 9.9). However, there was a statistically significant difference indicating an effect of exercise over the entire period (baseline to 3-months postoperatively) (p=0.0029). CONCLUSIONS: Eight weeks of supervised neuromuscular exercise prior to total joint arthroplasty (TJA) of the hip or knee did not confer additional benefits 3 months postoperatively compared with TJA alone. However, the intervention group experienced a statistically significant short-term benefit in ADL and pain, suggesting an earlier onset of postoperative recovery. TRIAL REGISTRATION: ClinicalTrials NCT01003756.

The effect of posterior and lateral approach on patient-reported outcome measures and physical function in patients with osteoarthritis, undergoing total hip replacement: a randomised controlled trial protocol.

BACKGROUND: Total hip replacement provides pain relief and improves physical function and quality of life in patients with end-stage hip osteoarthritis. The incidence of hip replacement operations is expected to increase due to the growing elderly population. Overall, the posterior approach and lateral approach are the two most commonly used approaches for hip replacement operations. The posterior approach is associated with an increased risk of revision due to dislocations, and some studies have shown that the lateral approach is associated with reduced patient-reported outcomes, including physical function and pain; however, this has not been investigated in a randomised controlled trial with a twelve-month follow-up. We hypothesized that the lateral approach has an inferior outcome in patient-reported outcome compared with the posterior approach after one year. METHODS/DESIGN: The trial is a prospective, double blinded, parallel-group controlled trial with balanced randomisation [1: 1]. Patients with hip osteoarthritis scheduled for hip replacement surgery, aged 45-70 years, will be consecutively recruited and randomised into two groups. Group A will receive hip replacement using the posterior approach, and Group B will receive hip replacement using the lateral approach. The primary end-point for assessing the outcome of the two interventions will be twelve months after surgery. Follow-up will also be performed after three and six months. The primary outcome is Hip Disability and Osteoarthritis Outcome Score, subscale of "Physical function Short form" (HOOS-PS) Secondary outcome measures include two other subscales of HOOS ("Pain" and "Hip related Quality of Life"), physical activity level (UCLA activity score), limping (HHS) and general health status (EQ-5D-3L). Explorative outcomes include physical function test, 3D-gait-analysis and muscle strength. DISCUSSION: To our knowledge, this is the first randomised controlled trial comparing the posterior approach with the lateral approach with patient reported outcome as the primary outcome and with a twelve-month follow-up. TRIAL REGISTRATION: Clinicaltrial.gov: NCT01616667.

The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol.

BACKGROUND: Surgical treatment of osteoarthritis with total knee arthroplasty (TKA) usually takes place in a complete bloodless field using a tourniquet. However, doing the surgery without a tourniquet may reduce muscle damage, post-surgery pain and led to improved functional rehabilitation and mobilization. METHODS/DESIGN: A prospective, blinded, parallel-group, controlled superiority trial, with balanced randomization [1:1]. Patients aged 50 or older eligible for primary TKA for osteoarthritis will be consecutively recruited from Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark. A total of 80 patients will be randomly allocated to TKA with or without tourniquet application providing 40 patients for each of the two treatment arms. The tourniquet assisted TKA group will have an automatic, micro-processor-based pneumatic tourniquet inflated around the thigh during surgery. The non-tourniquet assisted TKA group will have surgery performed without application of a tourniquet. The primary aim is to compare tourniquet assisted to non-tourniquet assisted TKA on patient-reported physical function (KOOS-ADL). The secondary aim is to compare post-surgery pain, function in sports and recreation, quality of life, and performance-based physical function. The explorative outcomes include; use of pain medication, single-fiber muscle damage, and changes in mechanical muscle function. The primary endpoint will be at 3-months following surgical treatment, and the time-point for analysis of the primary outcome. However, follow-up will continue up to 1 year, and provide medium-term results. The treatment effect (difference in KOOS-ADL) will be analyzed using a random effects regression model, crude and adjusted results will be reported, if needed. Analyses will be based on the intention-to-treat (ITT). Subsequent per-protocol analysis may be necessary in the event of a substantial number of patients (> 15%) being lost during follow-up. The number needed to treat (NNT) for a positive effect of treatment (>10 points on KOOS-ADL) will be reported. DISCUSSION: This is the first randomized clinical trial comparing the efficacy of tourniquet assisted TKA on patient-reported physical function supported by a range of performance-based secondary outcome measures. As such it will provide high quality evidence that may help determine whether tourniquet should be used in future TKA procedures in patients with osteoarthritis of the knee. TRIAL REGISTRATION: ClinicalTrials NCT01891266.

Low validity of the Sensewear Pro3 activity monitor compared to indirect calorimetry during simulated free living in patients with osteoarthritis of the hip.

BACKGROUND: To validate physical activity estimates by the Sensewear Pro3 activity monitor compared with indirect calorimetry during simulated free living in patients diagnosed with osteoarthritis of the hip pre or post total hip arthroplasty. METHODS: Twenty patients diagnosed with hip osteoarthritis (10 pre- and 10 post total hip arthroplasty; 40% female; age: 63.3 ± 9.0; BMI: 23.7 ± 3.7). All patients completed a 2 hour protocol of simulated free living with 8 different typical physical activity types. Energy consumption (kcal/min) was estimated by the Sense Wear pro3 Armband activity monitor and validated against indirect calorimetry (criterion method) by means of a portable unit (Cosmed K4b2). Bias and variance was analyzed using functional ANOVA. RESULTS: Mean bias during all activities was 1.5 Kcal/min 95%CI [1.3; 1.8] corresponding to 72% (overestimation). Normal gait speed showed an overestimation of 2.8 Kcal/min, 95%CI [2.3; 3.3] (93%) while an underestimation of -1.1 Kcal/min, 95%CI [-1.8; -0.3] (-25%) was recorded during stair climb. Activities dominated by upper body movements showed large overestimation with 4.37 Kcal/min, 95%CI [3.8; 5.1] (170%) being recorded during gardening. Both bias and variance appeared to be dependent on activity type. CONCLUSION: The activity monitor generally overestimated the energy consumption during common activities of low to medium intensity in the patient group. The size and direction of the bias was highly dependent on the activity type which indicates the activity monitor is of limited value in patients with hip osteoarthritis and that the results do not express the real energy expenditure.

Limited associations between passive range of motion and gross motor function in ambulant/semi-ambulant children and adolescents with cerebral palsy: A cross-sectional study.

BACKGROUND AND AIM: Cerebral palsy (CP) is the most common childhood motor disability, and the Cerebral Palsy Follow-Up Program (CPUP) in Nordic countries uses a traffic light system for passive range of motion (ROM) assessment to aid interpretation and guide decisions regarding interventions. However, the arbitrary chosen ROM threshold values and their potential clinical impact are uncertain. We investigated whether lower extremity ROM values were positively associated with gross motor function and whether gross motor function scores differ between the CPUP ROM thresholds. METHODS: This was a cross-sectional analysis of CPUP data for 841 ambulatory children and adolescents with CP, at a mean (SD) age of 9 (3). Regression analyses were employed to explore the relationship between gross motor capacity and performance (using the Gross Motor Function Measure (GMFM-66) and the Functional Mobility Scale (FMS) 5/50/500 m, respectively) and lower extremity ROM, measured with a goniometer. ROM was assessed both as continuous and categorical variables. RESULTS: We found that two out of ten continuous ROM measures were positively associated with gross motor function. Limited differences in gross motor function between the ROM thresholds were seen for seven out of ten ROM measures. The CPUP traffic light thresholds primarily differentiated gross motor function between the red and green categories, predominantly for the subgroup of participants with bilateral spastic CP. CONCLUSION: Limited associations between passive ROM and gross motor function in children and adolescents with CP were observed, indicating that there is more to consider than ROM when identifying whether interventions are needed.