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.

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.

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.

Naltrexone 6 mg once daily versus placebo in women with fibromyalgia: a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Low-dose naltrexone is used to treat fibromyalgia despite minimal evidence for its efficacy. This trial aimed to investigate whether 12-week treatment with 6 mg low-dose naltrexone was superior to placebo for reducing pain in women with fibromyalgia. METHODS: We did a single-centre, randomised, double-blind, placebo-controlled trial in Denmark. We enrolled women aged 18-64 years who were diagnosed with fibromyalgia. Participants were randomly assigned 1:1 to receive low-dose naltrexone (6 mg) or an identical-appearing placebo, using a computerised algorithm with no stratifications applied. Participants, investigators, outcome assessors, and statistical analysts were all masked to treatment allocation. The primary outcome was change in pain intensity on an 11-point numeric rating scale from baseline to week 12, in the intention-to-treat population. Safety was assessed in participants in the intention-to-treat population who received at least one dose of their allocated intervention. This trial was registered with ClincalTrials.gov (NCT04270877) and EudraCT (2019-000702-30). FINDINGS: We screened 158 participants for eligibility from Jan 6, 2021, to Dec 27, 2022, and 99 patients were randomly assigned to low-dose naltrexone (n=49) or placebo (n=50). The mean age was 50·6 years (SD 8·8), one (1%) of 99 participants was Arctic Asian and 98 (99%) were White. No participants were lost to follow-up. The mean change in pain intensity was -1·3 points (95% CI -1·7 to -0·8) in the low-dose naltrexone group and -0·9 (-1·4 to -0·5) in the placebo group, corresponding to a between-group difference of -0·34 (-0·95 to 0·27; p=0·27, Cohen's d 0·23). Discontinuations due to adverse events were four (8%) of 49 in the low-dose naltrexone group and three (6%) of 50 in the placebo group. 41 (84%) of 49 patients in the low-dose naltrexone group had an adverse event versus 43 (86%) of 50 in the placebo group. One serious adverse event occurred in the placebo group and no deaths occurred. INTERPRETATION: This study did not show that treatment with low-dose naltrexone was superior to placebo in relieving pain. Our results indicate that low-dose naltrexone might improve memory problems associated with fibromyalgia, and we suggest that future trials investigate this further. FUNDING: The Danish Rheumatism Association, Odense University Hospital, Danielsen's Foundation, and the Oak Foundation.

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.

Acute effects of robot-assisted body weight unloading on biomechanical movement patterns during overground walking.

Body weight unloading (BWU) is used in rehabilitation/training settings to reduce kinetic requirements, however different BWU methods may be unequally capable of preserving biomechanical movement patterns. Biomechanical analysis of both kinetic and kinematic movement trajectories rather than discrete variables has not previously been performed to describe the effect of BWU on gait patterns during horizontal walking. The aim of the present study was to investigate how robot-assisted BWU producing an dynamic unloading force on the body centre of mass, affects kinematic, kinetic, and spatiotemporal gait parameters in healthy young adults by use of time-continuous analysis. Twenty participants walked overground in a 3-D motion-capture lab at 0, 10, 20, 30, 40, and 50 % BWU at a self-selected speed. Vertical and anterior-posterior ground reaction forces (GRFs) and lower limb internal joint moments were obtained during the stance phase, while joint angles were obtained during entire strides. Time-continuous data were analysed using Statistical Parametric Mapping (SPM) and discrete data using conventional statistics to compare different BWU conditions by means of One-Way Repeated Measures Anova. With increasing BWU, corresponding reductions were observed for GRFs, internal joint moments, joint angles, walking speed, stride/step length and cadence. Observed effects were partially caused by decreased walking speed and increased BWU. While amplitude reductions were observed for kinetic and kinematic variables, trajectory shapes were largely preserved. In conclusion, dynamic robot-assisted BWU enables reduced kinetic requirements without distorting biomechanically normal gait patterns during overground walking in young healthy adults.

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.

The biomechanical differences of wearing safety shoes compared with everyday shoes on dynamic balance when tripping over an obstacle.

Safety shoes are known to challenge dynamic balance, but the interaction between footwear and trips has not been thoroughly explored. This study investigated the biomechanical differences on dynamic balance during unexpected trip perturbations between safety shoes and everyday shoes. The vertical position of the whole-body center of mass (CoM) and the linear momentum of the swing leg from seven females and sixteen males were analyzed in five subsequent gait cycles. Additionally, the recovery strategies (i.e., the displacement of the foot after tripping) were classified. Wearing safety shoes, the linear momentum of the foot and whole leg increased, and the vertical position of the whole-body CoM was lower after the perturbation. Additionally, the recovery strategy when wearing safety shoes demonstrated a lower displacement of the foot. In conclusion, wearing safety shoes was found to have negative biomechanical effects when having to circumvent a trip, and this potentially increased the risk of falling.

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.

Criterion validity of muscle strain analyses of skeletal muscle function in patients with multiple sclerosis.

BACKGROUND: Despite the wide range of existing performance measures to evaluate functional status of patients with multiple sclerosis, the heterogeneous nature of the disease hinders clinical characterization and monitoring of disease severity. Speckle tracking ultrasonography is a non-invasive technique to assess isolated muscle function by evaluating the contractile properties of muscle tissue, i.e. muscle strain. The aim of this study was to investigate whether muscle strain measured by speckle tracking ultrasonography could be a useful quantitative measure of muscle function in patients with multiple sclerosis. The criterion validity of muscle strain was compared to that of validated performance measures of upper and lower extremity function. METHODS: This cross-sectional study used baseline data from an explorative observational cohort study (the MUST study). Participants recruited from a hospital outpatient MS clinic underwent speckle tracking ultrasonography of the biceps brachii, supraspinatus, and soleus muscles of the dominant side according to pre-defined submaximal isometric contractions. Participants also completed the Timed 25-Foot Walk Test, the Six Spot Step Test, the 2-minute walking test, the Nine-Hole Peg Test, the 12-item Multiple Sclerosis Walking Scale, and the Oxford Shoulder Score. Gaussian distribution was investigated by visual inspection of normal probability plots and the Shapiro-Wilk test. The Timed 25-Foot Walk Test and Nine-Hole Peg Test were selected as gold standards for function of the lower and upper extremities, respectively. Criterion validity was assessed using Spearman's rank-order correlation coefficient ρ (rho), comparing the muscle strain and performance measures against predefined gold standards. Differences in criterion validity were estimated using squared correlations on the Fischer's Z-scale, with non-parametric bootstrapping to obtain bias-corrected, accelerated bootstrap confidence intervals (95% BCa). RESULTS: Criterion validity showed good to excellent correlations between the gold standard for lower extremity function and the 2-minute walking test and Six Spot Step Test, and a fair correlation to the 12-item Multiple Sclerosis Walking Scale. No significant correlation was found between the gold standard for upper extremity function and the performance measure. There were no significant correlations between the gold standards and muscle strain. CONCLUSION: The absence of criterion validity for muscle strain alongside fair to strong criterion validity for the performance measures indicates that speckle tracking ultrasonography assessment of muscle strain is either invalid or evaluates other constructs of multiple sclerosis. Muscle strain assessed by speckle tracking ultrasonography cannot be recommended for the evaluation of treatment effects or disease progression in multiple sclerosis.

Change in functional biomechanics following a targeted exercise intervention in patients with acetabular retroversion and femoroacetabular impingement syndrome.

BACKGROUND: Acetabular retroversion is a form of hip dysplasia that may cause femoroacetabular impingement syndrome (FAIS), leading to pain and restricted hip range of motion. An exercise intervention aiming at altering pelvis tilt and related functional biomechanics may be a useful first-line intervention for patients who are not eligible for surgical repositioning. RESEARCH QUESTION: Does squat and gait biomechanics change following an 8-week targeted exercise program in individuals with symptomatic acetabular retroversion and FAIS? METHODS: This prospective intervention study used participants as their own controls. Examinations were conducted at three time-points: T1 baseline; T2 following an 8-week control period; T3 after 8 weeks' intervention. At each time-point, three-dimensional motion analysis of a deep squat and level gait was performed, and pain intensity was recorded using a numerical rating scale (NRS 0-10). The intervention consisted of a home-exercise program to improve core stability and pelvic movement. Differences in waveforms between time-points across pelvis and lower-limb biomechanics were evaluated using statistical parametric mapping. Delta (Δ, differences between T1-T2 and T2-T3) was used to evaluate changes in spatiotemporal gait parameters and pain. RESULTS: Nineteen patients (18 females), mean age 22.6 (SD 4.5) years, BMI (kg/m2) 23.0 (SD 4.1), were included. Changes (Δ T1-T2 vs. Δ T2-T3) in squat biomechanics were observed as: (i) decreased anterior pelvic tilt, (ii) deeper vertical pelvis position, and (iii) increased knee flexion angle. Contrary, no significant changes in gait biomechanics, Δ walking speed, Δ step length, or NRS for pain were found. SIGNIFICANCE: Following a targeted exercise intervention, participants were able to squat deeper, potentially allowing better hip function. The deepened squat position was accompanied by increased knee flexion and reduced anterior pelvic tilt. Gait biomechanics and patient-reported pain remained unchanged post-intervention. These findings are important for future design of exercise interventions targeting pelvic tilt in symptomatic individuals.

The Effect of Progressive Resistance Exercise on Knee Muscle Strength and Function in Participants with Persistent Hamstring Deficit Following ACL Reconstruction: A Randomized Controlled Trial.

OBJECTIVE: To investigate the effect of progressive resistance exercise compared with low-intensity home-based exercises on knee-muscle strength and joint function in people with anterior cruciate ligament (ACL) reconstruction and persistent hamstring strength deficits at 12-24 months after surgery. DESIGN: Randomized controlled superiority trial with parallel groups, balanced randomization (1:1), and blinded outcome assessment. METHODS: People with ACL reconstruction (hamstring autograft) and persistent hamstring muscle strength asymmetry were recruited 1 to 2 years postsurgery and randomized to either 12 weeks of supervised progressive strength training (SNG), or 12 weeks of home-based, low-intensity exercises (CON). The primary outcome was between-group difference in change in maximal isometric knee flexor muscle strength at 12-week follow-up. RESULTS: Fifty-one participants (45% women, 27 ± 6 years) were randomized to SNG (n = 25) or CON (n = 26), with 88% follow-up rate at 12 weeks. People in the SNG group improved their knee flexor muscle strength (0.18 N·m/kg, 95% confidence interval [CI]: 0.07, 0.29; P = .002) more than the CON group, from baseline to 12 weeks. The SNG group also had superior Knee Injury and Osteoarthritis Outcome Scores for Pain (4.6, 95% CI: 0.4, 8.7; P = .031) and daily living function (4.7, 95% CI: 1.2, 8.2; P = .010) compared to the CON group. CONCLUSION: In people with persistent hamstring muscle strength deficits after ACL reconstruction, 12 weeks of supervised progressive strength training was superior to low-intensity home-based exercises for improving maximal knee flexor muscle strength and some patient-reported outcomes. J Orthop Sports Phys Ther 2023;53(1):40-48. Epub: 17 October 2022. doi:10.2519/jospt.2022.11360.

Test-retest reliability and agreement of lower-extremity kinematics captured in squatting and jumping preschool children using markerless motion capture technology.

The clinimetric properties of new technology should be evaluated in relevant populations before its implementation in research or clinical practice. Markerless motion capture is a new digital technology that allows for data collection in young children without some drawbacks commonly encountered with traditional systems. However, important properties, such as test-retest reliability, of this new technology have so far not been investigated. We recorded 63 preschool children using markerless motion capture (The Captury GmbH, Saarbrüken, Germany) while they performed squats and standing broad jumps. A retest session was conducted after 1 week. Recordings from the test session were processed twice to estimate the software-driven instrumental variability. Recordings from the first and second test sessions were compared to evaluate the week-to-week test-retest reliability. Statistical tests included 95% limits of agreement and intraclass correlations of absolute agreement (ICC). Jump length performance and four kinematic variables demonstrated acceptable instrumental variability (ICC > 0.76). The week-to-week reliability was excellent for jump length performance (ICC = 0.90) but poor to moderate (ICC < 0.55) for the kinematic variables. Our results indicate that preschool children exhibit considerable intra-individual kinematic variation from week-to-week during jump landings and squats. Consequently, we suggest that future work should explore individuals with persistent extreme kinematics over multiple test-sessions.

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.

Gait quality and function after fampridine treatment in patients with multiple sclerosis - A prospective cohort study.

BACKGROUND: Fampridine has shown to improve walking speed, motor control, and balance in patients with multiple sclerosis. However, potential fampridine-induced changes in gait quality and underlying mechanisms, evaluated by three-dimensional gait analysis, are poorly examined. The aim was to examine if two weeks of fampridine treatment would improve gait quality (using Gait Profile Score and Gait Variable Scores from three-dimensional gait analysis) and gait function (using performance-based tests, spatiotemporal parameters, and self-perceived gait function). METHODS: 14 participants with multiple sclerosis were included (9 women and 5 men, age 53.6 ± 12.8 years, disease duration 21 ± 9.1 years) in this cohort study. Tests were completed prior to fampridine and after 14 (± 1) days of treatment. Three-dimensional gait analyses were completed, and kinematic measures were calculated for overall gait quality using Gait Profile Score, and for joint-specific variables, Gait Variable Scores. Gait function was assessed using spatiotemporal parameters, performance-based tests, and a patient-reported outcome measure. Student's paired t-test/Wilcoxon signed rank test were used to compare baseline and follow-up variables. Sample size calculation for Gait Profile Score required at least 9 participants. FINDINGS: No fampridine-induced improvements in gait quality were demonstrated. For gait function, improvements were found in performance-based tests (Timed 25-Foot Walk: -11.5%; Six Spot Step Test: -13.9%; 2-Minute Walk Test: 18.2%) and self-perceived gait function (12-itemMS Walking Scale: -35.2%). INTERPRETATION: Although two weeks of fampridine treatment in patients with multiple sclerosis improved gait function, there was no change in overall kinematic quality of gait. TRIAL REGISTRATION: This work was collected as a part of a registered clinical trial (MUST): ClinicalTrials.govNCT03847545.

Exercise in patients with acetabular retroversion and excessive anterior pelvic tilt: A feasibility and intervention study.

BACKGROUND: Acetabular retroversion is associated with femoroacetabular impingement syndrome (FAIS). Anterior pelvic tilt enhances risk of FAIS. OBJECTIVES: To investigate feasibility and change in patient-reported symptoms of a home-based exercise intervention in patients with acetabular retroversion and excessive anterior pelvic tilt, in comparison with a prior control period. DESIGN: Prospective intervention study. METHODS: Patients (18-40 years) not eligible for surgery, with radiographic signs of acetabular retroversion and excessive anterior pelvic tilt were recruited. An 8-week control period was followed by an 8-week training period. The home-based intervention consisted of education and exercises for core stability, muscle strengthening and stretching for reducing anterior pelvic tilt. Feasibility assessments were dropout (≤10%), adherence (≥75% of sessions), exercise-related pain, and adverse events. Primary outcome was change in the Copenhagen Hip and Groin Outcome Score (HAGOS) pain-subscale. Pelvic tilt was measured by EOS scanning. RESULTS: Forty-two patients (93% female, mean age 22.2 ± 4.2 years) were included. Dropout rate was 7% and satisfactory adherence was demonstrated by 85%. Exercise-related pain and adverse events were acceptable. Between-period mean change score for HAGOS-PAIN was 5.2 points (95% CI: -0.3-10.6) and -1.6° (95% CI: -3.9-0.7) of anterior pelvic tilt. Patients responding positively (≥10 points) (n = 10, 26%), had pre-exercise moderate pain (HAGOS-PAIN 47.5-70 points). CONCLUSIONS: Current exercise intervention was feasible. However, we found no clinically relevant changes in self-reported hip-related pain or anterior pelvic tilt. Post hoc responder analysis revealed that patients with moderate pain at baseline might benefit from this exercise.

Evaluation of functional outcome measures after fampridine treatment in patients with multiple sclerosis - An interventional follow-up study.

OBJECTIVE: The purpose of this interventional study on participants with multiple sclerosis (MS) with walking disability was to evaluate changes in functional hand and walking measurements after fampridine treatment, after stratifying by the Expanded Disability Status Scale (EDSS). We furthermore wanted to investigate different functional measurements to evaluate their ability to detect responders to fampridine with a clinically relevant improvement. METHODS: Patients were recruited from the MS Clinic at Odense University Hospital and were classified into two disability groups based on their EDSS score (moderate EDSS (EDSSMod) 4.5-5.5 [n = 19] and severe EDSS (EDSSSev) 6.0-7.0 [n = 14]). At baseline (visit 1) they completed the Timed 25-Foot Walk (T25FW), 2-Minute Walk Test (2MWT), Nine Hold Peg Test (9HPT), 12-item Multiple Sclerosis Walking Scale (MSWS-12), and the Six Spot Step Test (SSST). Participants were given 10 mg twice daily fampridine for 14 days before retested (visit 2). For each measurement, cut-off values were used to define responders with a clinically relevant improvement to treatment. The measurements were evaluated separately and in combination. RESULTS: Of the 33 participants, 25 (75.8%) were identified as having a clinically relevant improvement (CRI). For all patients combined (EDSSAll), all five measurements showed significant functional improvement after treatment. For the individual measurements, the highest participant response rates after 14 days of fampridine treatment were seen on the MSWS-12 (57.6%) and 2MWT (42.4%). The 2MWT also showed the largest performance improvement (18.5%) from visit 1 to visit 2. For patients with severe disability (EDSSSev), no significant improvement was seen after fampridine treatment on the T25FW, and most of the responders to T25FW had moderate disability (EDSSMod, 71.5%). Conversely for the SSST, most responders were EDSSSev (83.3%). No participants had a clinically relevant improvement on the 9HPT. The combination of T25FW, SSST, and MSWS-12 was less sensitive in distinguishing responders from non-responders, whereas the combination of 2MWT and MSWS-12 identified the same responders and could better distinguish fampridine responders from non-responders. CONCLUSION: EDSS level did not influence the effect of fampridine treatment on functional hand and walking measures and the responsiveness of the measurements differed only a little between moderate and severe EDSS levels. The combination of self-reported walking capacity (MSWS-12) and walking endurance (2MWT) was better than T25FW, SSST, and MSWS-12 at detecting clinically meaningful improvement after fampridine treatment, which could prove useful in the clinical monitoring of walking disabilities in MS during fampridine treatment.

Sports Participation and Performance 5 Years After Arthroscopic Partial Meniscectomy: A Retrospective Cohort Study of 288 Patients.

OBJECTIVE: To investigate return to sport (RTS) approximately 5 years after arthroscopic partial meniscectomy (APM). DESIGN: Retrospective cohort study. METHODS: Knee Arthroscopy Cohort Southern Denmark patients were asked about RTS and reasons for non-RTS approximately 5 years (range, 4-6 years) after APM using online questionnaires. Patients engaged in their sport at the pre-injury level at follow-up were classified as "RTS" (or "returned to sport") and as being engaged in their sport with (1) full participation and performance, (2) reduced performance, or (3) both reduced participation and performance. Self-reported knee function was assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS). RESULTS: We included 288 patients (mean ± SD age, 49 ± 12 years; 44% women). Of these, 172 patients (60%; 95% confidence interval, 54%-65%) were classified as returned to sport, but only 42% (72/172) reported full participation and performance. Persistent problems with the operated knee were reported by 60% of the patients as the main reason for reduced participation or performance and by 70% of the patients as the main reason for not returning to pre-injury levels of their sport. Patients who had returned to sport, on average, improved by 10.1 points (95% confidence interval, 5.7-14.4) more in KOOS4 scores from baseline to 5 years than non-RTS patients. CONCLUSION: At approximately 5 years after APM, 6 in every 10 patients had returned to their sport at pre-injury levels, but only 1 in every 4 returned with full participation and performance, mainly due to persistent knee problems. Greater improvements in KOOS scores were observed in patients who were classified as returned to sport. J Orthop Sports Phys Ther 2022;52(4):224-232. doi:10.2519/jospt.2022.10785.

Gait function improvements, using Cardiff Classifier, are related to patient-reported function and pain following hip arthroplasty.

Summarizing results of three-dimensional (3D) gait analysis into a comprehensive measure of overall gait function is valuable to discern to what extent gait function is affected, and later recovered after surgery and rehabilitation. This study aimed to investigate whether preoperative gait function, quantified and summarized using the Cardiff Classifier, can predict improvements in postoperative patient-reported activities of daily living, and overall gait function 1 year after total hip arthroplasty (THA). Secondly, to explore relationships between pre-to-post surgical change in gait function versus changes in patient-reported and performance-based function. Thirty-two patients scheduled for THA and 25 nonpathological individuals were included in this prospective cohort study. Patients were evaluated before THA and 1 year postoperatively using 3D gait analysis, patient-reported outcomes, and performance-based tests. Kinematic and kinetic gait parameters, derived from 3D gait analysis, were quantified using the Cardiff Classifier. Linear regressions investigated the predictive value of preoperative gait function on postoperative outcomes of function, and univariate correlations explored relationships between pre-to-post surgical changes in outcome measures. Preoperative gait function, by means of Cardiff Classifier, explained 35% and 30% of the total variance in change in patient-reported activities of daily living, and in gait function, respectively. Moderate-to-strong correlations were found between change in gait function and change in patient-reported function and pain, while no correlations were found between change in gait function and performance-based function. Clinical significance: Preoperative gait function predicts postsurgical function to a moderate degree, while improvements in gait function after surgery are more closely related to how patients perceive function than their maximal performance of functional tests.

Low-dose naltrexone for the treatment of fibromyalgia: protocol for a double-blind, randomized, placebo-controlled trial.

BACKGROUND: Low-dose naltrexone (LDN) is used widely as an off-label treatment for pain despite limited evidence for its effectiveness. A few small trials with a high risk of bias have investigated the effect of LDN on pain associated with fibromyalgia in women, but larger and more methodologically robust studies are needed. The primary aim of this randomized controlled trial is to investigate if 12 weeks of LDN treatment is superior to placebo in reducing the average pain intensity during the last 7 days in women with fibromyalgia. METHODS: A single-center, permuted block randomized, double-blind, placebo-controlled, parallel-group trial will be performed in Denmark. Randomization comprises 100 women aged 18-64 years diagnosed with fibromyalgia who will be treated with either LDN or placebo for 12 weeks including a 4-week titration phase. The primary outcome is change in average pain intensity (during the last 7 days) from baseline to 12 weeks. Secondary outcomes are other fibromyalgia-related symptoms, i.e., tenderness, fatigue, sleep disturbance, stiffness, memory problems, depression, anxiety and measures of global assessment, physical function, impact of fibromyalgia, pain distribution, and health-related quality of life. Intention-to-treat analysis will be performed, and the number of responders with a more than 15%, 30%, and 50% improvement of pain after 12 weeks will be calculated for the LDN and placebo groups. Exploratory outcomes include measures of pain sensitivity, muscle performance, and biomarkers. DISCUSSION: This study will contribute with high-level evidence on the efficacy of low-dose naltrexone for the treatment of pain in women with fibromyalgia. Secondary outcomes include both disease-specific and generic components investigating whether LDN influences other symptoms than pain. Explorative outcomes are included to provide greater insight into the mechanism of action of LDN and possibly a better understanding of the underlying pathology in fibromyalgia. TRIAL REGISTRATION: EudraCT 2019-000702-30. Registered on 12 July 2019. ClinicalTrials.gov NCT04270877. Registered on 17 February 2020.