Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 24
Filter
1.
BMJ Open ; 14(4): e078240, 2024 Apr 02.
Article in English | MEDLINE | ID: mdl-38569685

ABSTRACT

INTRODUCTION: Custom insoles are a routine treatment for many foot pathologies, and the use of computer-aided design and computer-aided manufacturing (CAD/CAM) is well established within clinical practice in the UK. The method of foot shape capture used to produce insoles varies throughout orthotic services. This trial aims to investigate the effectiveness of two common shape-capture techniques on patient-reported outcomes in people who require insoles for a foot or ankle pathology. METHODS AND ANALYSIS: This double-blinded randomised controlled trial will involve two intervention groups recruited from a National Health Service orthotic service. Participants will be randomly assigned to receive a pair of custom CAD/CAM insoles, manufactured either from a direct digital scan or a foam box cast of their feet and asked to wear the insoles for 12 weeks. The primary outcome measure will be the Foot Health Status Questionnaire (FHSQ) pain subdomain, recorded at baseline (immediately after receiving the intervention), 4, 8 and 12 weeks post intervention. Secondary outcome measures will include FHSQ foot function and foot health subdomains recorded at baseline, 4, 8 and 12 weeks. The Orthotic and Prosthetic User Survey Satisfaction with Device will be recorded at 12 weeks. The transit times associated with each arm will be measured as the number of days for each insole to be delivered after foot shape capture. Tertiary outcome measures will include participant recruitment and dropout rates, and intervention adherence measured as the daily usage of the insoles over 12 weeks. The change in FHSQ scores for the subdomains and insole usage will be compared between the groups and time points, and between group differences in time in transit, cost-time analysis and environmental impact will be compared. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Health Research Authority, London Stanmore Research Ethics Committee (22/LO/0579). Study findings will be submitted for publication in peer-reviewed journals, conference presentations and webinars. TRIAL REGISTRATION NUMBER: NCT05444192.


Subject(s)
Foot Diseases , State Medicine , Humans , Foot , Research Design , Pain , Computer-Aided Design , Randomized Controlled Trials as Topic
2.
Sports Biomech ; : 1-12, 2023 Jun 20.
Article in English | MEDLINE | ID: mdl-37339268

ABSTRACT

Despite squatting being important in strength training and rehabilitation, few studies have investigated motor unit (MU) behaviour. This study explored the MU behaviour of vastus medialis (VM) and vastus lateralis (VL) during the concentric and eccentric phases of a squat exercise performed at two speeds. Twenty-two participants had surface dEMG sensors attached over VM and VL, and IMUs recorded thigh and shank angular velocities. Participants performed squats at 15 and 25 repetitions per minute in a randomised order, and EMG signals were decomposed into their MU action potential trains. A four factor (muscle × speed × contraction phase × sexes) mixed methods ANOVA revealed significant main effects for MU firing rates between speeds, between muscles and between sexes, but not contraction phases. Post hoc analysis showed significantly greater MU firing rates and amplitudes in VM. A significant interaction was seen between speed and the contraction phases. Further analysis revealed significantly greater firing rates during the concentric compared to the eccentric phases, and between speeds during the eccentric phase only. VM and VL respond differently during squatting depending on speed and contraction phase. These new insights in VM and VL MU behvaviour may be useful when designing training and rehabilitation protocols.

3.
J Foot Ankle Res ; 16(1): 12, 2023 Mar 10.
Article in English | MEDLINE | ID: mdl-36899385

ABSTRACT

BACKGROUND: Haemophilia is an X-linked recessive genetic disorder characterised by bleeding within soft tissue and joints. The ankle is disproportionally affected by haemarthropathy when compared to the elbows and knees; reported as the most affected joints in patients with haemophilia. Despite advances in treatment, patients still report ongoing pain and disability, however, the impact has not been evaluated, nor has the effect on health-related quality of life (HRQoL) or foot and ankle patient-reported outcome measures (PROMs). The primary aim of this study was to establish the impact of ankle haemarthropathy in patients with severe and moderate haemophilia A and B. Secondly to identify the clinical outcomes associated with a decline in HRQoL and foot and ankle PROMs. METHODS: A cross-sectional multi-centre questionnaire study was conducted across 18 haemophilia centres in England, Scotland and Wales with a recruitment target of 245 participants. The HAEMO-QoL-A and Manchester-Oxford Foot Questionnaire (MOXFQ) (foot and ankle) with total and domain scores measured impact on HRQOL and foot and ankle outcomes. Demographics, clinical characteristics, ankle haemophilia joint health scores, multi-joint haemarthropathy and Numerical Pain Rating Scales (NPRS) of "ankle pain over the past six months" were collected as a measure of chronic ankle pain. RESULTS: A total of 243 of 250 participants provided complete data. HAEMO-QoL-A and MOXFQ (foot and ankle) total and index scores indicated worse HRQoL with total scores ranging from a mean of 35.3 to 35.8 (100 best-health) and 50.5 to 45.8 (0 best-health) respectively. NPRS (mean (SD)) ranged from 5.0 (2.6) to 5.5 (2.5), with median (IQR) ankle haemophilia joint health score of 4.5 (1 to 12.5) to 6.0 (3.0 to 10.0) indicating moderate to severe levels of ankle haemarthropathy. Ankle NPRS over six months and inhibitor status were associated with decline in outcome. CONCLUSIONS: HRQoL and foot and ankle PROMs were poor in participants with moderate to severe levels of ankle haemarthropathy. Pain was a major driver for decline in HRQoL and foot and ankle PROMs and use of NPRS has the potential to predict worsening HRQoL and PROMs at the ankle and other affected joints.


Subject(s)
Hemophilia A , Humans , Hemophilia A/complications , Quality of Life , Ankle , Cross-Sectional Studies , Surveys and Questionnaires , Pain , Arthralgia , Patient Reported Outcome Measures
4.
Haemophilia ; 29(2): 600-607, 2023 Mar.
Article in English | MEDLINE | ID: mdl-36528893

ABSTRACT

INTRODUCTION: Moderate haemophilia has traditionally been associated with less complications than severe haemophilia. Changes in treatment recommendations have highlighted the burden of moderate haemophilia with a subset of patients with a severe bleeding phenotype. The ankle joint is disproportionally affected by ankle haemarthropathy however the impact has not been evaluated in moderate haemophilia, nor the effect on health related quality of life (HRQoL) or foot and ankle outcomes. AIMS: To establish the impact of ankle haemarthropathy in patients with moderate haemophilia. METHODS: A multicentre questionnaire study recruited patients from 11 haemophilia centres in England, Scotland and Wales. The HAEMO-QoL-A and Manchester-Oxford foot and ankle questionnaire (MOXFQ) with total and domain scores measured impact. Measures of pain and ankle haemophilia joint health (HJHS) scores were also collected. RESULTS: Twenty-nine participants were recruited. HAEMO-QoL A mean (SD) total scores of 10.8 (5.2) of 100 (best health) and foot and ankle specific MOXFQ total scores of 45.5 (24.7) above zero (best outcome) indicate poor HRQoL and foot and ankle outcomes. Average ankle pain over past 6 months of (0-10) 5.5 (SD2.5) was reported and median (IQR) ankle HJHS of 3.0 (1;12.5) to 4.5 (0;9.5) for the left and right ankles. CONCLUSION: HRQoL and foot and ankle specific outcomes are poor in patients with moderate haemophilia and ankle haemarthropathy, driven by chronic levels of ankle joint pain. Despite moderate haemophilia being considered less affected by haemarthrosis and haemarthropathy, patients with a bleeding or haemarthropathy phenotype are clinically similar to patients with severe haemophilia A.


Subject(s)
Hemophilia A , Humans , Hemophilia A/complications , Ankle , Ankle Joint , Quality of Life , Hemorrhage/complications , Pain/complications , Arthralgia
5.
J Foot Ankle Res ; 15(1): 68, 2022 Sep 08.
Article in English | MEDLINE | ID: mdl-36071489

ABSTRACT

BACKGROUND: Different multi-segment foot models have been used to explore the effect of foot orthoses. Previous studies have compared the kinematic output of different multi-segment foot models, however, no study has explored if different multi-segment foot models detect similar kinematic changes when wearing a foot orthoses. The aim of this study was to compare the ability of two different multi-segment foot models to detect kinematic changes at the hindfoot and forefoot during the single and double support phases of gait when wearing a foot orthosis. METHODS: Foot kinematics were collected during walking from a sample of 32 individuals with and without a foot orthosis with a medial heel bar using an eight-camera motion capture system. The Oxford Foot Model (OFM) and a multi-segment foot model using the Calibrated Anatomical System Technique (CAST) were applied simultaneously. Vector field statistical analysis was used to explore the kinematic effects of a medial heel bar using the two models, and the ability of the models to detect any changes in kinematics was compared. RESULTS: For the hindfoot, both models showed very good agreement of the effect of the foot orthosis across all three anatomical planes during the single and double support phases. However, for the forefoot, the level of agreement between the models varied with both models showing good agreement of the effect in the coronal plane but poorer agreement in the transverse and sagittal planes. CONCLUSIONS: This study showed that while consistency exists across both models for the hindfoot and forefoot in the coronal plane, the forefoot in the transverse and sagittal planes showed inconsistent responses to the foot orthoses. This should be considered when interpreting the efficacy of different interventions which aim to change foot biomechanics.


Subject(s)
Foot Orthoses , Biomechanical Phenomena/physiology , Foot/physiology , Gait/physiology , Humans , Walking/physiology
7.
Haemophilia ; 28(3): 422-436, 2022 May.
Article in English | MEDLINE | ID: mdl-35245413

ABSTRACT

INTRODUCTION: Haemarthrosis is a clinical feature of haemophilia leading to haemarthropathy. The ankle joint is most commonly affected, resulting in significant pain, disability and a reduction in health-related quality of life. Footwear and orthotic devices are effective in other diseases that affect the foot and ankle, such as rheumatoid arthritis, but little is known about their effect in haemophilia. AIMS: To review the efficacy and effectiveness of footwear and orthotic devices in the management of ankle joint haemarthrosis and haemarthropathy in haemophilia. METHODS: A systematic literature review was conducted. Two review authors independently screened studies for inclusion and appraised methodological quality using Joanna Briggs Institute Critical Appraisal checklists. A narrative analysis was undertaken. RESULTS: Ten studies involving 271 male participants were eligible for inclusion. All studies were quasi-experimental; three employed a within-subject design. Two studies included an independent comparison or control group. A range of footwear and orthotic devices were investigated. Limited evidence from non-randomised studies suggested that footwear and orthotic devices improve the number of ankle joint bleeding episodes, gait parameters and patient-reported pain. CONCLUSION: This review demonstrates a lack of robust evidence regarding the efficacy and effectiveness of footwear and orthotic devices in the management of ankle joint haemarthrosis and haemarthropathy in haemophilia. Methodological heterogeneities and limitations with the study designs, small sample sizes and limited follow-up of participants exist. Future studies utilising randomised designs, larger sample sizes, long-term follow-up and validated patient-reported outcome measures are needed to inform the clinical management of ankle joint haemarthrosis and haemarthropathy.


Subject(s)
Hemarthrosis , Hemophilia A , Ankle , Ankle Joint , Female , Hemarthrosis/etiology , Hemarthrosis/therapy , Hemophilia A/complications , Hemophilia A/therapy , Humans , Male , Orthotic Devices , Pain , Quality of Life
8.
BMJ Open ; 12(1): e052358, 2022 Jan 12.
Article in English | MEDLINE | ID: mdl-35022172

ABSTRACT

OBJECTIVES: To report the 12-month prevalence of joint bleeds from the National Haemophilia Database (NHD) and Haemtrack, a patient-reported online treatment diary and concurrent joint disease status using the haemophilia joint health score (HJHS) at individual joint level, in children and adults with severe haemophilia A and B (HA/HB) without a current inhibitor. DESIGN: A 2018 retrospective database study of NHD from which 2238 cases were identified, 463 patients had fully itemised HJHS of whom 273 were compliant in recording treatment using Haemtrack. SETTING: England, Wales and Scotland, UK. PARTICIPANTS: Children (<18 years) and adults (≥18 years) with severe HA and HB (factor VIII/factor IX, <0.01 iu/mL) without a current inhibitor. PRIMARY AND SECONDARY OUTCOMES: Prevalence of joint haemarthrosis and concurrent joint health measured using the HJHS. RESULTS: The median (IQR) age of children was 10 (6-13) and adults 40 (29-50) years. Haemarthrosis prevalence in HA/HB children was 33% and 47%, respectively, and 60% and 42%, respectively, in adults. The most common site of haemarthrosis in children was the knee in HA and ankle in HB. In adults, the incidence of haemarthrosis at the ankles and elbows was equal. The median total HJHS in HA/HB children was 0 and in adults with HA/HB, were 18 and 11, respectively. In adults with HA/HB, the median ankle HJHS of 4.0 was higher than the median HJHS of 1.0 for both the knee and elbow. CONCLUSION: Despite therapeutic advances, only two-thirds of children and one-third of adults were bleed-free, even in a UK cohort selected for high compliance with prophylaxis. The median HJHS of zero in children suggests joint health is relatively unaffected during childhood. In adults, bleed rates were highest in ankles and elbows, but the ankles led to substantially worse joint health scores.


Subject(s)
Hemophilia A , Adult , Child , Hemarthrosis/complications , Hemarthrosis/epidemiology , Hemophilia A/complications , Hemophilia A/drug therapy , Hemophilia A/epidemiology , Humans , Middle Aged , Patient Reported Outcome Measures , Prevalence , Retrospective Studies , United Kingdom/epidemiology
9.
Gait Posture ; 84: 93-101, 2021 02.
Article in English | MEDLINE | ID: mdl-33290904

ABSTRACT

BACKGROUND: Sensorimotor foot orthoses is an alternative concept, which in addition to mechanical effects, are designed to change muscle activation by altering sensory input to the plantar surface of the foot. However, there is little evidence of how these affect the kinematics of the foot during gait. RESEARCH QUESTION: The aim of the study was to explore the immediate effect of calcaneal medial heel bars and retrocapital bars on foot kinematics during the stance phase of gait. METHODS: Kinematic data were collected from 32 healthy individuals using an eight camera motion capture system and a six-degrees-of-freedom multi-segment foot model in three different orthotic conditions; calcaneal medial heel bar, retrocapital bar, and no orthosis. Vector field statistical analysis was performed to explore the effect of the orthotic conditions over the kinematic time series curves during stance phase. Peak median and interquartile ranges were also reported during the different phases of stance. RESULTS: The calcaneal medial bar significantly decreased rearfoot eversion for the majority of the stance phase and compensatory increased midfoot eversion during the entire stance phase compared to the no orthosis condition. The retrocapital bar rotated the foot externally significantly abducting the rearfoot for the entire stance phase and the midfoot for the majority of stance phase. SIGNIFICANCE: The calcaneal medial heel bar and retrocapital bar significantly altered the foot kinematics in a way that may benefit patients with abnormal pronation and intoeing gait.


Subject(s)
Biomechanical Phenomena/physiology , Foot Orthoses/standards , Gait Analysis/methods , Female , Healthy Volunteers , Humans , Male
10.
IEEE Trans Biomed Eng ; 67(7): 1989-2004, 2020 07.
Article in English | MEDLINE | ID: mdl-31899409

ABSTRACT

Diabetes is highly prevalent throughout the world and imposes a high economic cost on countries at all income levels. Foot ulceration is one devastating consequence of diabetes, which can lead to amputation and mortality. Clinical assessment of diabetic foot ulcer (DFU) is currently subjective and limited, impeding effective diagnosis, treatment and prevention. Studies have shown that pressure and shear stress at the plantar surface of the foot plays an important role in the development of DFUs. Quantification of these could provide an improved means of assessment of the risk of developing DFUs. However, commercially-available sensing technology can only measure plantar pressures, neglecting shear stresses and thus limiting their clinical utility. Research into new sensor systems which can measure both plantar pressure and shear stresses are thus critical. Our aim in this paper is to provide the reader with an overview of recent advances in plantar pressure and stress sensing and offer insights into future needs in this critical area of healthcare. Firstly, we use current clinical understanding as the basis to define requirements for wearable sensor systems capable of assessing DFU. Secondly, we review the fundamental sensing technologies employed in this field and investigate the capabilities of the resultant wearable systems, including both commercial and research-grade equipment. Finally, we discuss research trends, ongoing challenges and future opportunities for improved sensing technologies to monitor plantar loading in the diabetic foot.


Subject(s)
Diabetes Mellitus , Diabetic Foot , Wearable Electronic Devices , Diabetic Foot/diagnosis , Foot , Humans , Monitoring, Physiologic , Stress, Mechanical
11.
J Arthroplasty ; 35(3): 877-885, 2020 03.
Article in English | MEDLINE | ID: mdl-31699529

ABSTRACT

BACKGROUND: Total hip arthroplasty (THA) implants are routinely tested for their tribological performance through regulatory preclinical wear testing (eg, ISO-14242). The standardized loading conditions defined in these tests consist of simplified waveforms, which do not specifically represent in vivo loads in different groups of patients. The aim of this study is to investigate, through musculoskeletal modeling, patient-specific and activity-related variation in hip contact forces (HCFs) in a large cohort of THA patients during common activities of daily living (ADLs). METHODS: A total of 132 THA patients participated in a motion-capture analysis while performing different ADLs, including walk, fast walk, stair ascent, and descent (locomotor); sit to stand, stand to sit, squat, and lunge (nonlocomotor). HCFs were then calculated using the AnyBody Modeling System and qualitatively compared across all activities. The influence of gender on HCFs was analyzed through statistical parametric mapping analysis. RESULTS: Systematic differences were found in HCF magnitudes and individual components in both locomotor and nonlocomotor ADLs. The qualitative analysis of the ADLs revealed a large range and a large variability in forces experienced at the hip during different activities. Significant differences in the 3-dimensional loading patterns were observed between males and females across most activities. CONCLUSION: THA patients present a large variability in the forces experienced at the hip joint during their daily life. The interpatient variation might partially explain the heterogeneity observed in implant survival rates. A more extensive preclinical implant testing standard under clinically relevant loading conditions has been advocated to better predict and avoid clinical wear problems.


Subject(s)
Arthroplasty, Replacement, Hip , Hip Joint , Activities of Daily Living , Biomechanical Phenomena , Female , Hip Joint/surgery , Humans , Male
12.
J Biomech ; 87: 19-27, 2019 04 18.
Article in English | MEDLINE | ID: mdl-30876738

ABSTRACT

To examine functional differences in total hip replacement patients (THR) when stratified either by age or by functional ability as defined by self-selected walking speed. THR patients and a control group underwent three-dimensional motion analysis under self-selected normal and fast walking conditions. Patients were stratified into five age groups for comparison with existing literature. The THR cohort was also stratified into three functional groups determined by their self-selected gait speed (low function <1SD of total cohort's mean walking speed; high function >1SD; normal function within 1SD). Hip kinematics, ground reaction forces, joint moments and joint powers in all three planes (x-y-z) were analysed. 137 THR and 27 healthy control patients participated. When stratified by age, during normal walking the youngest two age groups walked quicker than the oldest two groups (p < 0.0001) but between-group differences were not consistent across age strata. The differences were diminished under the fast walking condition. When stratified by function, under normal walking conditions, the low function and normal function THR groups had a reduced extension angle (mean = 1.75°, SD = ±7.75, 1.26°â€¯±â€¯7.42, respectively) compared to the control group (-6.07°â€¯±â€¯6.43; p < 0.0001). The low function group had a reduced sagittal plane hip power (0.75 W/kg ±â€¯0.24), reduced flexor (0.60 Nm/kg ±â€¯0.85) and extensor moment (0.51 Nm/kg ±â€¯0.17) compared to controls (p < 0.0001). These differences persisted under the fast walking condition. There were systematic differences between patients when stratified by function, in both walking conditions. Age-related differences were less systematic. Stratifying by biomechanical factors such as gait speed, rather than age, might be more robust for investigating functional differences.


Subject(s)
Arthroplasty, Replacement, Hip , Gait , Hip Joint , Walking Speed , Age Factors , Aged , Aged, 80 and over , Biomechanical Phenomena , Cohort Studies , Female , Hip Joint/physiology , Humans , Kinetics , Male , Middle Aged
13.
Orthop Trauma ; 30(3): 232-238, 2016 Jun.
Article in English | MEDLINE | ID: mdl-27594929

ABSTRACT

This paper provides an introduction to the biomechanics of the ankle, introducing the bony anatomy involved in motion of the foot and ankle. The complexity of the ankle anatomy has a significant influence on the biomechanical performance of the joint, and this paper discusses the motions of the ankle joint complex, and the joints at which it is proposed they occur. It provides insight into the ligaments that are critical to the stability and function of the ankle joint. It describes the movements involved in a normal gait cycle, and also highlights how these may change as a result of surgical intervention such as total joint replacement or fusion.

14.
Gait Posture ; 49: 235-240, 2016 09.
Article in English | MEDLINE | ID: mdl-27459418

ABSTRACT

BACKGROUND: Midfoot osteoarthritis (OA) is more prevalent and strongly associated with pain than previously thought. Excessive mechanical loading of the midfoot structures may contribute to midfoot OA and studies suggest that functional foot orthoses (FFO) may relieve pain through improving function. This exploratory study aimed to evaluate the mechanical effect of two off-the-shelf FFOs, compared to a sham orthosis in people with midfoot OA. METHODS: Thirty-three participants with radiographically confirmed symptomatic midfoot OA were randomly assigned to wear either a commercially available FFO or a sham orthosis. After wearing their assigned orthoses for 12 weeks, plantar pressure measurements were obtained under shoe-only and assigned orthoses conditions. Participants assigned to the sham, were additionally tested wearing a second type of FFO at the end of trial. Descriptive mean change (±95% confidence intervals) in plantar pressure for each orthoses condition, versus a shoe only baseline condition are presented. FINDINGS: Compared to the shoe only conditions, both FFOs decreased hindfoot and forefoot maximum force and peak pressure, whilst increasing maximum force and contact area under the midfoot. The sham orthosis yielded plantar pressures similar to the shoe-only condition. INTERPRETATION: Findings suggest that both types of off-the-shelf FFO may provide mechanical benefit, whilst the sham orthoses produced similar findings to the shoe only condition, indicating appropriate sham properties. This paper provides insight into the mechanisms of action underpinning the use of FFOs and sham orthoses, which can inform future definitive RCTs examining the effect of orthoses on midfoot OA.


Subject(s)
Foot Joints , Foot Orthoses , Foot/physiopathology , Osteoarthritis/physiopathology , Shoes , Biomechanical Phenomena , Female , Humans , Male , Middle Aged , Osteoarthritis/rehabilitation , Pressure
15.
Clin Rheumatol ; 35(4): 987-96, 2016 Apr.
Article in English | MEDLINE | ID: mdl-25917211

ABSTRACT

This randomised feasibility study aimed to examine the clinical and biomechanical effects of functional foot orthoses (FFOs) in the treatment of midfoot osteoarthritis (OA) and the feasibility of conducting a full randomised controlled trial. Participants with painful, radiographically confirmed midfoot OA were recruited and randomised to receive either FFOs or a sham control orthosis. Feasibility measures included recruitment and attrition rates, practicality of blinding and adherence rates. Clinical outcome measures were: change from baseline to 12 weeks for severity of pain (numerical rating scale), foot function (Manchester Foot Pain and Disability Index) and patient global impression of change scale. To investigate the biomechanical effect of foot orthoses, in-shoe foot kinematics and plantar pressures were evaluated at 12 weeks. Of the 119 participants screened, 37 were randomised and 33 completed the study (FFO = 18, sham = 15). Compliance with foot orthoses and blinding of the intervention was achieved in three quarters of the group. Both groups reported improvements in pain, function and global impression of change; the FFO group reporting greater improvements compared to the sham group. The biomechanical outcomes indicated the FFO group inverted the hindfoot and increased midfoot maximum plantar force compared to the sham group. The present findings suggest FFOs worn over 12 weeks may provide detectable clinical and biomechanical benefits compared to sham orthoses. This feasibility study provides useful clinical, biomechanical and statistical information for the design and implementation of a definitive randomised controlled trial to evaluate the effectiveness of FFOs in treating painful midfoot OA.


Subject(s)
Foot Orthoses , Foot/physiopathology , Osteoarthritis/therapy , Adult , Aged , Biomechanical Phenomena , Double-Blind Method , Feasibility Studies , Female , Humans , Male , Middle Aged , Pain/physiopathology , Patient Compliance , Pressure , Shoes , Treatment Outcome
16.
Rheumatology (Oxford) ; 55(2): 320-6, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26361882

ABSTRACT

OBJECTIVE: There are unique challenges to designing and carrying out high-quality trials testing therapeutic devices in OA and other rheumatic diseases. Such challenges include determining the mechanisms of action of the device and the appropriate sham. Design of device trials is more challenging than that of placebo-controlled drug trials. Our aim was to develop recommendations for designing device trials. METHODS: An Arthritis Research UK study group comprised of 30 rheumatologists, physiotherapists, podiatrists, engineers, orthopaedists, trialists and patients, including many who have carried out device trials, met and (using a Delphi-styled approach) came to consensus on recommendations for device trials. RESULTS: Challenges unique to device trials include defining the mechanism of action of the device and, therefore, the appropriate sham that provides a placebo effect without duplicating the action of the active device. Should there be no clear-cut mechanism of action, a three-arm trial including a no-treatment arm and one with presumed sham action was recommended. For individualized devices, generalizable indications and standardization of the devices are needed so that treatments can be generalized. CONCLUSION: A consensus set of recommendations for device trials was developed, providing a basis for improved trial design, and hopefully improvement in the number of effective therapeutic devices for rheumatic diseases.


Subject(s)
Clinical Trials as Topic/standards , Consensus , Orthopedic Procedures/standards , Osteoarthritis, Knee/therapy , Humans , Orthopedic Procedures/methods , United Kingdom
17.
J Orthop Res ; 33(11): 1646-54, 2015 Nov.
Article in English | MEDLINE | ID: mdl-25991385

ABSTRACT

Many conservative treatments exist for medial knee osteoarthritis (OA) which aims to reduce the external knee adduction moment (EKAM). The objective of this study was to determine the difference between different shoes and lateral wedge insoles on EKAM, knee adduction angular impulse (KAAI), external knee flexion moment, pain, and comfort when walking in individuals with medial knee OA. Seventy individuals with medial knee OA underwent three-dimensional walking gait analysis in five conditions (barefoot, control shoe, typical wedge, supported wedge, and mobility shoe) with pain and comfort recorded concurrently. The change in EKAM, KAAI, external knee flexion moment, pain, and comfort were assessed using multiple linear regressions and pairwise comparisons. Compared with the control shoe, lateral wedge insoles and barefoot walking significantly reduced early stance EKAM and KAAI. The mobility shoe showed no effect. A significant reduction in latter stance EKAM was seen in the lateral wedge insoles compared to the other conditions, with only the barefoot condition reducing the external knee flexion moment. However, the mobility shoe showed significant immediate knee pain reduction and improved comfort scores. Different lateral wedge insoles show comparable reductions in medial knee loading and in our study, the mobility shoe did not affect medial loading.


Subject(s)
Knee Joint/physiology , Orthotic Devices/statistics & numerical data , Osteoarthritis, Knee/therapy , Shoes/statistics & numerical data , Aged , Arthralgia/therapy , Female , Humans , Male , Middle Aged , Weight-Bearing
18.
J Orthop Res ; 32(9): 1147-54, 2014 Sep.
Article in English | MEDLINE | ID: mdl-24903067

ABSTRACT

Studies of lateral wedge insoles (LWIs) in medial knee osteoarthritis (OA) have shown reductions in the average external knee adduction moment (EKAM) but no lessening of knee pain. Some treated patients actually experience increases in the EKAM which could explain the overall absence of pain response. We examined whether, in patients with painful medial OA, reductions in the EKAM were associated with lessening of knee pain. Each patient underwent gait analysis whilst walking in a control shoe and two LWI's. We evaluated the relationship between change in EKAM and change in knee pain using Spearman Rank Correlation coefficients and tested whether dichotomizing patients into biomechanical responders (decreased EKAM) and non-responders (increased EKAM) would identify those with reductions in knee pain. In 70 patients studied, the EKAM was reduced in both LWIs versus control shoe (-5.21% and -6.29% for typical and supported wedges, respectively). The change in EKAM using LWIs was not significantly associated with the direction of knee pain change. Further, 54% were biomechanical responders, but these persons did not have more knee pain reduction than non-responders. Whilst LWIs reduce EKAM, there is no clearcut relationship between change in medial load when wearing LWIs and corresponding change in knee pain.


Subject(s)
Arthralgia/physiopathology , Foot Orthoses , Knee Joint/physiopathology , Osteoarthritis, Knee/physiopathology , Osteoarthritis, Knee/therapy , Weight-Bearing/physiology , Aged , Arthralgia/epidemiology , Arthralgia/prevention & control , Biomechanical Phenomena/physiology , Female , Gait/physiology , Humans , Male , Middle Aged , Prevalence , Range of Motion, Articular/physiology , Treatment Failure , Treatment Outcome
19.
J Rheumatol ; 40(3): 309-15, 2013 Mar.
Article in English | MEDLINE | ID: mdl-23322462

ABSTRACT

OBJECTIVE: Few if any prevention strategies are available for knee osteoarthritis (OA). In those with symptomatic medial OA, the contralateral knee may be at high risk of disease, and a reduction in medial loading in that knee might prevent disease or its progression there. Our aim was to determine how often persons with medial OA on 1 side had either concurrent or later medial OA on the contralateral side, and whether an intervention known to reduce medial loading in affected knees with medial OA might reduce medial loading in the contralateral knee. Lateral wedge insoles reduce loading across an affected medial knee but their effect on the contralateral knee is unknown. METHODS: To determine the proportion of persons with medial knee OA who had concurrent medial contralateral OA or developed contralateral medial OA later, we examined knee radiographs from the longitudinal Framingham Osteoarthritis Study. Then, to examine an approach to reducing medial load in the contralateral knee, 51 people from a separate study with painful medial tibiofemoral OA underwent gait analysis wearing bilateral controlled shoes with no insoles, and then with 2 types of wedge insoles laterally posted by 5°. Primary outcome was the external knee adduction moment (EKAM) in the contralateral knee. Nonparametric CI were constructed around the median differences in percentage change in the affected and contralateral sides. RESULTS: Of Framingham subjects with medial radiograph knee OA, 137/152 (90%) either had concurrent contralateral medial OA or developed it within 10 years. Of those with medial symptomatic knee OA, 43/67 (64%) had or developed the same disease state in the contralateral knee. Compared to a control shoe, medial loading was reduced substantially on both the affected (median percentage EKAM change -4.84%; 95% CI -11.33% to -0.65%) and contralateral sides (median percentage EKAM change -9.34%; 95% CI -10.57% to -6.45%). CONCLUSION: In persons with medial OA, the contralateral knee is also at high risk of medial OA. Bilateral reduction in medial loading in knees by use of strategies such as lateral wedge insoles might not only reduce medial load in affected knees but prevent knee OA or its progression on the contralateral side.


Subject(s)
Knee Joint/physiopathology , Orthotic Devices , Osteoarthritis, Knee/prevention & control , Weight-Bearing/physiology , Aged , Disease Progression , Female , Gait/physiology , Humans , Knee Joint/diagnostic imaging , Male , Middle Aged , Osteoarthritis, Knee/diagnostic imaging , Osteoarthritis, Knee/physiopathology , Radiography
20.
Exp Brain Res ; 216(1): 71-80, 2012 Jan.
Article in English | MEDLINE | ID: mdl-22038720

ABSTRACT

This study investigated the importance of binocular vision to foot placement accuracy when stepping onto a floor-based target during gait initiation. Starting from stationary, participants placed alternate feet onto targets sequentially positioned along a straight travel path with the added constraint that the initial target (target 1) could move in the medio-lateral (M-L) direction. Repeated trials when target 1 remained stationary or moved laterally at the instant of lead-limb toe-off (TO) or 200 ms after TO (early swing) were undertaken under binocular and monocular viewing. Catch trials when target 1 shifted medially were also undertaken. Foot-reach kinematics, foot trajectory corrections and foot placement accuracy for the step onto target 1 were determined via 3D motion analyses. Peak foot-reach velocity and initial foot-reach duration were unaffected by vision condition but terminal foot-reach duration was prolonged under monocular conditions (p = 0.002). Foot trajectory alteration onsets were unaffected by vision condition, but onsets occurred sooner when the target shifted in early swing compared to at TO (p = 0.033). M-L foot placement accuracy decreased (p = 0.025) and variability increased (p = 0.05) under monocular conditions, particularly when stepping onto the moving target. There was no difference between vision conditions in A-P foot placement accuracy. Results indicate that monocular vision provides sufficient information to determine stepping distance and correctly transport the foot towards the target but binocular vision is required to attain a precise M-L foot placement; particularly so when stepping onto a moving target. These findings are in agreement with those found in the reaching and grasping literature, indicating that binocular vision is important for end-point precision.


Subject(s)
Foot/innervation , Gait/physiology , Locomotion/physiology , Psychomotor Performance/physiology , Vision, Binocular/physiology , Adult , Analysis of Variance , Attention , Biomechanical Phenomena , Female , Floors and Floorcoverings , Humans , Male , Young Adult
SELECTION OF CITATIONS
SEARCH DETAIL
...