Through-knee versus above-knee amputation for vascular and non-vascular major lower limb amputations.

BACKGROUND: Diabetes and vascular disease are the leading causes of lower limb amputation. Currently, 463 million adults are living with diabetes, and 202 million with peripheral vascular disease, worldwide. When a lower limb amputation is considered, preservation of the knee in a below-knee amputation allows for superior functional recovery when compared with amputation at a higher level. When a below-knee amputation is not feasible, the most common alternative performed is an above-knee amputation. Another possible option, which is less commonly performed, is a through-knee amputation which may offer some potential functional benefits over an above-knee amputation. OBJECTIVES: To assess the effects of through-knee amputation compared to above-knee amputation on clinical and rehabilitation outcomes and complication rates for all patients undergoing vascular and non-vascular major lower limb amputation. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases; the World Health Organization International Clinical Trials Registry Platform; and the ClinicalTrials.gov trials register to 17 February 2021. We undertook reference checking, citation searching, and contact with study authors to identify additional studies. SELECTION CRITERIA: Published and unpublished randomised controlled trials (RCTs) comparing through-knee amputation and above-knee amputation were eligible for inclusion in this study. Primary outcomes were uncomplicated primary wound healing and prosthetic limb fitting. Secondary outcomes included time taken to achieve independent mobility with a prosthesis, health-related quality of life, walking speed, pain, and 30-day survival. DATA COLLECTION AND ANALYSIS: Two review authors independently reviewed all records identified by the search. Data collection and extraction were planned in line with recommendations outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We planned to assess the certainty of evidence using the GRADE approach. MAIN RESULTS: We did not identify RCTs that met the inclusion criteria for this review. AUTHORS' CONCLUSIONS: No RCTs have been conducted to determine comparative clinical or rehabilitation outcomes of through-knee amputation and above-knee amputation, or complication rates. It is unknown whether either of these approaches offers improved outcomes for patients. RCTs are needed to guide practice and to ensure the best outcomes for this patient group.

The effects of exercise to promote quality of life in individuals with traumatic brain injuries: a systematic review.

OBJECTIVE: To systematically review the effects of exercise interventions that may enhance quality of life (QOL) in individuals with traumatic brain injury (TBI). METHODS: A systematic search was conducted using five databases up to April 2018. Studies were included if QOL was quantified following an exercise programme for people with a TBI. Methodological quality was assessed using a validated scoring checklist. Two independent reviewers assessed study inclusion and methodological quality. RESULTS: Thirteen studies met the inclusion criteria (seven RCTs, six non-RCTs). The median total scores for the quality assessment tool were 26.1 (RCTs), and 21.3 (non-RCTs), out of 33. Eight out of the 13 studies reported improved QOL following an exercise programme. The duration of the interventions varied from 8-12 weeks. The most common programmes involved moderate to vigorous exercise; with a frequency and duration of 3-5 times/week for 30-60 minutes. CONCLUSION: Due to the diversity of the exercise training interventions, heterogeneity of patient characteristics, multitude of QOL instruments and outcome domains assessed, it was not possible to draw any definitive conclusion about the effectiveness of exercise interventions. However, this review identified positive trends to enhance various aspects of QOL measured using a range of assessment tools.

Do Predictive Relationships Exist Between Postural Control and Falls Efficacy in Unilateral Transtibial Prosthesis Users?

OBJECTIVE: To assess whether variables from a postural control test relate to and predict falls efficacy in prosthesis users. DESIGN: Twelve-month within- and between-participants repeated measures design. Participants performed the limits of stability (LOS) test protocol at study baseline and at 6-month follow-up. Participants also completed the Falls Efficacy Scale-International (FES-I) questionnaire, reflecting the fear of falling, and reported the number of falls monthly between study baseline and 6-month follow-up, and additionally at 9- and 12-month follow-ups. SETTING: University biomechanics laboratories. PARTICIPANTS: Participants (N=24) included a group of active unilateral transtibial prosthesis users of primarily traumatic etiology (n=12) with at least 1 year of prosthetic experience and age- and sex-matched control participants (n=12). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Postural control variables derived from center of pressure data obtained during the LOS test, which was performed on and reported by the Neurocom Pro Balance Master, namely reaction time, movement velocity (MVL), endpoint excursion (EPE), maximum excursion (MXE), and directional control (DCL). Number of falls and total FES-I scores. RESULTS: During the study period, the prosthesis users group had higher FES-I scores (U=33.5, P=.02), but experienced a similar number of falls, compared to the control group. Increased FES-I scores were associated with decreased EPE (r= -0.73, P=.02), MXE (r= -0.83, P<.01) and MVL (r= -0.7, P=.03) in the prosthesis users group, and DCL (r= -0.82, P<.01) in the control group, all in the backward direction. CONCLUSIONS: Study baseline measures of postural control, in the backward direction only, are related to and potentially predictive of subsequent 6-month FES-I scores in relatively mobile and experienced prosthesis users.

Association between somatosensory, visual and vestibular contributions to postural control, reactive balance capacity and healthy ageing in older women.

We investigated the biological systems involved in maintaining equilibrium during unstable and perturbed conditions in 39 healthy older women and estimated the annual difference in performance across the older age spectrum using regression. The largest annual difference in equilibrium occurred when the somatosensory system received inaccurate feedback and visual input was removed. With age, weight distribution became asymmetric at the onset of backwards perturbations, possibly in preparation for executing a stepping strategy. When one sensory system was challenged, postural responses were stable suggesting other systems compensated. When multiple sensory systems were challenged, significant differences in postural control emerged with age.

A systematic review of muscle morphology and function in intermittent claudication.

OBJECTIVE: Intermittent claudication (IC) is frequently associated with deterioration in walking capacity and physical function, and it can often result in an impairment in balance. Whereas supervised exercise is recommended by the National Institute for Health and Care Excellence as the first-line treatment, the mechanism behind walking improvement is poorly understood. The existing literature suggests that there may be some physiologic change to the skeletal muscle contributing to the functional impairment, but these data are conflicting. We therefore sought to undertake a systematic review to clarify the muscle properties of patients with IC. METHODS: A systematic review of randomized and nonrandomized trials that investigated the role of muscle function in patients diagnosed with IC was undertaken using MEDLINE, Cochrane Central Register of Controlled Trials, and Embase databases. The searches were limited from 1947 to June 2016 in the English language. RESULTS: The search yielded a total of 506 articles, of which 206 were duplicate articles. Of the remaining 300, a total of 201 were excluded from full-text analysis; 99 full-text articles were assessed for eligibility, with 30 articles deemed appropriate for inclusion in the review. There were four main categories of functional outcome measures: muscle strength, muscle size, muscle fiber type, and muscle metabolism. A total of 2837 patients were included in the study. Nine studies reported on muscle strength, incorporating isometric, concentric, eccentric, and endurance measures. Eight studies reported on muscle size, incorporating circumference, computed tomography scans, and ultrasound imaging techniques. Eleven studies reported on muscle fibers, incorporating fiber type proportions, fiber size, and capillarity measures. Seven papers reported on muscle metabolism, incorporating adenosine diphosphate recovery and phosphocreatine recovery measures. CONCLUSIONS: Previous literature has found clear evidence that strength (of the calf and thigh musculature) and calf characteristics are related to mortality and functional declines. However, this review has demonstrated the vast array of muscle groups assessed and multiple methods employed to determine strength; therefore, it is unclear exactly what measure of "strength" is impaired. Furthermore, the underlying morphologic causes of potential changes in strength are unclear. This information is essential for designing optimal exercise interventions. The data acquired during this systematic review are heterogeneous, with a substantial lack of high-quality intervention-based studies. Future research should endeavor to establish standardized testing procedures and to implement randomized controlled trials for targeted therapeutic interventions.

Gastrocnemius muscle architecture and achilles tendon properties influence walking distance in claudicants with peripheral arterial disease.

INTRODUCTION: The extent to which gastrocnemius muscle and Achilles tendon properties contribute to the impaired walking endurance of claudicants is not known. METHODS: Ultrasound images quantified muscle architecture of the lateral and medial gastrocnemius (GL and GM) and were combined with dynamometry during plantarflexor contractions to calculate tendon stress, strain, stiffness, the Young modulus, and hysteresis. Key parameters were entered into multiple regression models to explain walking endurance. RESULTS: Worse disease severity was significantly associated with longer fascicle: tendon length ratios (GL R = -0.789 and GM R = -0.828) and increased tendon hysteresis (R = -0.740). Walking endurance could be explained by GL and GM pennation angle, maximum tendon force, tendon hysteresis, and disease severity (R(2) = ∼0.6). CONCLUSIONS: Peripheral arterial disease was associated with functionally important changes in muscle and tendon properties, including the usage of stored elastic energy. Interventions known to target these characteristics should be adopted as a means to improve walking endurance.

Acute changes in kinematic and muscle activity patterns in habitually shod rearfoot strikers while running barefoot.

The aim of this study was to observe changes in the kinematics and muscle activities when barefoot running was initially adopted by six habitually shod, recreational rearfoot striking runners. Participants ran on a treadmill shod for 5 min, completed 3 × 10-min intervals of barefoot running and then completed a final minute of shod running at a self-selected pace. Dependent variables (speed, joint angles at foot-contact, joint range of motion (ROM), mean and peak electromyography (EMG) activity) were compared across conditions using repeated measures ANOVAs. Anterior pelvic tilt and hip flexion significantly decreased during barefoot conditions at foot contact. The ROM for the trunk, pelvis, knee and ankle angles decreased during the barefoot conditions. Mean EMG activity was reduced for biceps femoris, gastrocnemius lateralis and tibialis anterior during barefoot running. The peak activity across the running cycle decreased in biceps femoris, vastus medialis, gastrocnemius medialis and tibialis anterior during barefoot running. During barefoot running, tibialis anterior activity significantly decreased during the pre-activation and initial contact phases; gastrocnemius lateralis and medialis activity significantly decreased during the push-off phase. Barefoot running caused immediate biomechanical and neuromuscular adaptations at the hip and pelvis, which persisted when the runners donned their shoes, indicating that some learning had occurred during an initial short bout of barefoot running.

Dynamic muscle quality of the plantar flexors is impaired in claudicant patients with peripheral arterial disease and associated with poorer walking endurance.

OBJECTIVE: Peripheral arterial disease and intermittent claudication (PAD-IC) negatively affects physical activity and function. There is evidence for plantarflexor muscle dysfunction and weakness; however, the extent to which this dysfunction can be attributed to reduced muscle size or quality, or both, is not yet known. This study investigated whether in vivo plantarflexor muscle quality during static and dynamic contractions is altered by PAD-IC and whether such changes are associated with impaired walking endurance according to initial and absolute claudication distances. METHODS: The study recruited 22 participants, consisting of 10 healthy controls and 12 claudicant patients with occlusion of the superficial femoral artery (seven unilateral and five bilateral). Muscle quality of the combined gastrocnemius muscles during static contractions was calculated by normalizing the estimated maximal potential muscle force to the physiological cross-sectional area of the lateral and medial gastrocnemius. Muscle quality during dynamic contractions of the combined plantarflexor muscles was calculated as the ratio of peak voluntary concentric plantarflexor power and the summed volume of lateral and medial gastrocnemius. RESULTS: Dynamic muscle quality was 24% lower in the claudicating-limb and asymptomatic-limb groups compared with controls (P = .017 and P = .023). The differences were most apparent at the highest contraction velocity (180°/s). Dynamic muscle quality was associated with reduced walking endurance (R = 0.689, P = .006 and R = 0.550, P = .042 for initial and absolute claudication distance, respectively). The claudicating-limb group demonstrated a trend toward reduced static muscle quality compared with controls (22%, P = .084). The relative contribution of the soleus muscle to plantarflexion maximum voluntary contraction was significantly higher in the claudicating-limb and asymptomatic-limb groups than in controls (P = .012 and P = .018). CONCLUSIONS: The muscle strength of the plantarflexors in those with PAD-IC appears to be impaired at high contraction velocities. This may be explained by some reduction in gastrocnemii muscle quality and a greater reliance on the prominently type I-fibered soleus muscle. The reduced dynamic capability of the plantarflexor muscles was associated with disease severity and walking ability; therefore, efforts to improve plantarflexor power through dynamic exercise intervention are vital to maintain functional performance.

'A whole different ball game': the qualitative experience of older adults with a transtibial amputation and the use of a self-aligning prosthetic ankle-foot on the STEPFORWARD trial.

BACKGROUND: Older patients with lower limb amputation, categorised as having "limited community mobility", are under-researched. Understanding their experience with a new prosthetic ankle-foot is important when designing clinical trials. The aim of this qualitative study was to explore the adjustments they made after amputation and the acceptability of a self-aligning ankle-foot (SA-AF) to older adults. METHODS: Fourteen participants, who took part in the STEPFORWARD randomised controlled feasibility trial (ISRCTN15043643), were purposively recruited; nine were intervention participants and five were standard care participants. They were asked to reflect on their life prior to and consider the adjustments they made following their amputation. Participants in the intervention group were also asked about their views of the new SA-AF compared to their standard non-SA-AF. A thematic analysis was undertaken. RESULTS: Three broad themes were identified: The impact of the amputation; Role of clinical support; and Experiences of the SA-AF. The findings tell a narrative of the long-term impact that amputation has on these individuals' lives. Participants randomised to receive the SA-AF were very positive about it, reporting less pain, greater mobility and being able to do more. CONCLUSION: Participants who used the SA-AF found it an acceptable intervention. These findings suggest that a full-scale RCT is warranted.

There is a high degree of acceptability among an older patient group with a transtibial amputation to use a self-aligning ankle foot.Patients reported experiencing better mobility and more prosthetic comfort with the self-aligning ankle-foot.Key outcomes important to participants include engagement in social and daily activities and balance confidence.

Percutaneous transluminal angioplasty results in improved physical function but not balance in patients with intermittent claudication.

OBJECTIVE: The aim of this study was to identify whether revascularization by percutaneous transluminal angioplasty (PTA) for patients with intermittent claudication improved measures of functional performance including balance. METHODS: A prospective observational study was performed at a single tertiary vascular center. Patients with symptomatic intermittent claudication (Rutherford grades 1-3) were recruited to the study. Participants were assessed at baseline (pre-PTA) and then 3, 6, and 12 months post-PTA for markers of (1) lower limb ischemia (treadmill walking distances and ankle-brachial pressure index), (2) physical function (6-minute walk, Timed Up and Go, and chair stand time), (3) balance impairment using computerized dynamic posturography with the Sensory Organization Test, and (4) quality of life (VascuQoL and Short Form Health Survey [SF-36]). RESULTS: Forty-three participants underwent PTA. Over 12 months, a significant improvement was demonstrated in initial (P = .04) and maximum treadmill walking distance (P = .019). Physical functional ability improved across all outcome measures (P < .02), and some domains of both generic (P < .03) and disease-specific quality of life (P < .01). No significant improvement in balance was demonstrated by the Sensory Organization Test (P = .24). CONCLUSIONS: Balance impairment is common in claudicants and does not improve with revascularization. Further research regarding effective treatment of balance impairment is required in this specific group of patients.

Balance impairment, physical ability, and its link with disease severity in patients with intermittent claudication.

BACKGROUND: To determine whether increasing claudication severity is associated with impaired balance and physical functional ability. METHODS: A prospective observational study in claudicants was performed. Disease severity was determined according to Rutherford's criteria. Patient's balance was assessed objectively using computerized dynamic posturography (CDP-Sensory Organization Test [SOT]; NeuroCom). "Bedside" assessment of balance was performed using the Timed Up and Go (TUG) test (dynamic balance) and the Full Tandem Stance test (static balance). Physical function was assessed using the Summary Physical Performance Battery (SPPB) score. RESULTS: 185 claudicants were assessed (median age of 69 [IQR 63-74] years; 137 [74.1%] men). Fourteen claudicants were classified as Rutherford grade 0, 26 as grade I, 76 as grade II, and 69 as grade III. All Rutherford groups were comparable for age, gender, BMI, and comorbidities. Increasing Rutherford grade was associated with a significant deterioration in objective balance as determined by a failed SOT test: 3 (21.4%) in grade 0; 9 (34.6%) in grade I; 39 (52.7%) in grade II; and 41 (59.4%) in grade III (chi-squared 9.693, df 3, P = 0.021). A significant difference was also found with dynamic balance (TUG test), but not static balance (full tandem stance). Increasing claudication severity was also associated with significantly worse physical function: SPPB score. CONCLUSIONS: Specific objective tests demonstrate impaired balance and physical function are common in claudicants and become more frequent with increasing severity of claudication. Simple "bedside" measures may be sufficiently sensitive to detect this.

Relationship between stair ascent gait speed, bone density and gait characteristics of postmenopausal women.

Stair ascent is a biomechanically challenging task for older women. Bone health may affect gait stability during stair walking. This study investigated the gait biomechanics associated with stair ascent in a group of postmenopausal women in relation to walking speed and bone health, quantified by T-score. Forty-five healthy women (mean (SD) age: 67 (14) years), with bone density ranging from healthy to osteoporotic (T-score range +1 to -3), ascended a custom-made five-step staircase with two embedded force plates, surrounded by 10 motion capture cameras, at their self-selected speed. Multivariate regression analyses investigated the explained variance in gait parameters in relation to stair ascent speed and T-score of each individual. Stair ascent speed was 0.65 (0.1) m·s-1 and explained the variance (R2 = 9 to 47%, P ≤ 0.05) in most gait parameters. T-score explained additional variance in stride width (R2 = 20%, P = 0.014), pelvic hike (R2 = 19%, P = 0.011), pelvic drop (R2 = 21%, P = 0.007) and hip adduction (R2 = 7%, P = 0.054). Increased stride width, and thereby a wider base of support, accompanied by increased frontal plane hip kinematics, could be important strategies to improve dynamic stability during stair ascent among this group of women. These findings suggest that targeted exercises of the hip abductors and adductors, including core trunk musculature, could improve dynamic stability during more challenging locomotor tasks. Balance exercises that challenge base of support could also benefit older women with low bone mineral density who may be at risk of falls.

Agreement and relationship between measures of absolute and relative intensity during walking: A systematic review with meta-regression.

INTRODUCTION: A metabolic equivalent (MET) is one of the most common methods used to objectively quantify physical activity intensity. Although the MET provides an 'objective' measure, it does not account for inter-individual differences in cardiorespiratory fitness. In contrast, 'relative' measures of physical activity intensity, such as heart rate reserve (HRR), do account for cardiorespiratory fitness. The purpose of this systematic review with meta-regression was to compare measures of absolute and relative physical activity intensity collected during walking. METHODS: A systematic search of four databases (SPORTDiscus, Medline, Academic Search Premier and CINAHL) was completed. Keyword searches were: (i) step* OR walk* OR strid* OR "physical activity"; (ii) absolute OR "absolute intensity" OR mets OR metabolic equivalent OR actigraph* OR acceleromet*; (iii) relative OR "relative intensity" OR "heart rate" OR "heart rate reserve" OR "VO2 reserve" OR VO2* OR "VO2 uptake" OR HRmax* OR metmax. Categories (i) to (iii) were combined using 'AND;' with studies related to running excluded. A Bayesian regression was conducted to quantify the relationship between METs and %HRR, with Bayesian logistic regression conducted to examine the classification agreement between methods. A modified Downs and Black scale incorporating 13 questions relative to cross-sectional study design was used to assess quality and risk of bias in all included studies. RESULTS: A total of 15 papers were included in the systematic review. A comparison of means between absolute (METs) and relative (%HRR, %HRmax, %VO2R, %VO2max, HRindex) values in 8 studies identified agreement in how intensity was classified (light, moderate or vigorous) in 60% of the trials. We received raw data from three authors, incorporating 3 studies and 290 participants. A Bayesian random intercept logistic regression was conducted to examine the agreement between relative and absolute intensity, showing agreement in 43% of all trials. Two studies had identical relative variables (%HRR) totalling 240 participants included in the Bayesian random intercept regression. The best performing model was a log-log regression, which showed that for every 1% increase in METs, %HRR increased by 1.12% (95% CI: 1.10-1.14). Specifically, the model predicts at the lower bound of absolute moderate intensity (3 METs), %HRR was estimated to be 33% (95%CI: 18-57) and at vigorous intensity (6 METs) %HRR was estimated to be 71% (38-100). CONCLUSION: This study highlights the discrepancies between absolute and relative measures of physical activity intensity during walking with large disagreement observed between methods and large variation in %HRR at a given MET. Consequently, health professionals should be aware of this lack of agreement between absolute and relative measures. Moreover, if we are to move towards a more individualised approach to exercise prescription and monitoring as advocated, relative intensity could be more highly prioritised.

Biomechanical differences between able-bodied and spinal cord injured individuals walking in an overground robotic exoskeleton.

BACKGROUND: Robotic assisted gait training (RAGT) uses a powered exoskeleton to support an individual's body and move their limbs, with the aim of activating latent, pre-existing movement patterns stored in the lower spinal cord called central pattern generators (CPGs) to facilitate stepping. The parameters that directly stimulate the stepping CPGs (hip extension and ipsilateral foot unloading) should be targeted to maximise the rehabilitation benefits of these devices. AIM: To compare the biomechanical profiles of individuals with a spinal cord injury (SCI) and able-bodied individuals inside the ReWalkTM powered exoskeleton and to contrast the users' profiles with the exoskeleton. METHODS: Eight able-bodied and four SCI individuals donned a ReWalkTM and walked along a 12-meter walkway, using elbow crutches. Whole-body kinematics of the users and the ReWalkTM were captured, along with GRF and temporal-spatial characteristics. Discreet kinematic values were analysed using a Kruskall-Wallis H and Dunn's post-hoc analysis. Upper-body differences, GRF and temporal-spatial characteristics were analysed using a Mann-Whitney U test (P<0.05). RESULTS: Walking speed ranged from 0.32-0.39m/s. Hip abduction, peak knee flexion and ankle dorsiflexion for both the SCI and able-bodied groups presented with significant differences to the ReWalkTM. The able-bodied group presented significant differences to the ReWalkTM for all kinematic variables except frontal plane hip ROM (P = 0.093,δ = -0.56). Sagittal plane pelvic and trunk ROM were significantly greater in the SCI vs. able-bodied (P = 0.004,δ = -1; P = 0.008,δ = -0.94, respectively). Posterior braking force was significantly greater in the SCI group (P = 0.004, δ = -1). DISCUSSION: The different trunk movements used by the SCI group and the capacity for the users' joint angles to exceed those of the device suggest that biomechanical profiles varied according to the user group. However, upright stepping with the ReWalkTM device delivered the appropriate afferent stimulus to activate CPGs as there were no differences in key biomechanical parameters between the two user groups.

Computerized dynamic posturography in the objective assessment of balance in patients with intermittent claudication.

One-third of all elderly patients fall each year and impaired balance has been recognized as a specific risk factor. Intermittent claudication is common among the elderly population, affecting approximately 5% of the population over the age of 50. The aim of this proof-of-concept study was to assess the prevalence of impaired balance among elderly claudicants and to assess each patient's insight into their own risk of falling. A total of 58 claudicants (45 men), median age of 70 (interquartile range = 65-73) years, underwent objective balance assessment by using computerized dynamic posturography. As compared with 195 (5%) historic controls, 24 (41%) of the claudicants demonstrated abnormal balance when the Sensory Organization Test (SOT) was used. Vestibular dysfunction occurred in 52% of the claudicants. Abnormalities including somatosensory (22%), visual function (17%), and preferential reliance on inaccurate visual cues (17%) occurred less often. Prolonged Motor Control Test latency times were uncommon (n = 13) and were in most cases evenly distributed between those with normal (n = 7) and abnormal (n = 6) composite SOT scores. There was a significant difference in history of falling between claudicants with abnormal and normal SOT scores (p = 0.003), with a higher number of patients with abnormal SOT having experienced falling in the past year. However, no correlation between fear of falling and composite SOT score was found (Spearman rank correlation, r = 0.124; p = 0.381). Impaired balance, particularly secondary to vestibular problems, is very common among claudicants and may predispose to a high incidence of falls. Claudicants with abnormal balance are more likely to have a history of falls but not a fear of falling, thus potentially rendering these patients to be at a greater risk.

A block randomised controlled trial investigating changes in postural control following a personalised 12-week exercise programme for individuals with lower limb amputation.

BACKGROUND: Individuals with a lower limb amputation (LLA) have an increased risk of falls and often report lower balance confidence. They must compensate for altered mechanics and prosthetic limitations in order to execute appropriate motor responses to postural perturbations. Personalised exercise could be an effective strategy to enhance balance and reduce falls. RESEARCH QUESTION: In this study, we investigated whether a personalised exercise programme could improve postural control and self-reported balance confidence in individuals with an LLA. METHODS: Participants were block randomised into two groups (exercise, n = 7; control, n = 7) based on age and level of amputation. The exercise group completed a 12-week personalised exercise programme, including home-based exercise sessions, consisting of balance, endurance, strength, and flexibility training. The control group continued with their normal daily activities. All participants performed the Sensory Organization Test (SOT) and Motor Control Test (MCT) on the NeuroCom SMART Equitest, and completed the Activities-specific Balance Confidence-UK (ABC) self-report questionnaire, at baseline and post-intervention. RESULTS AND SIGNIFICANCE: Exercise group equilibrium scores improved significantly when standing on an unstable support surface with no visual input and inaccurate somatosensory feedback (SOT condition 5, P < 0.012, d = 1.45). There were significant group*time interactions for medium (P = 0.029) and large (P = 0.048) support surface forward translations, which were associated with a trend towards increased weight-bearing on the intact limb in the control group (medium: P = 0.055; large: P = 0.087). No significant changes in ABC score were observed. These results indicate reduced reliance on visual input, and/or enhanced interpretation of somatosensory input, following an exercise programme. However, objective improvements in aspects of postural control were not associated with subjective improvements in self-reported balance confidence. More weight-bearing asymmetry in the control group suggests that a lack of targeted exercise training may have detrimental effects, with potential adverse long-term musculoskeletal consequences, that were quantifiable within a short timeframe.

STEPFORWARD study: a randomised controlled feasibility trial of a self-aligning prosthetic ankle-foot for older patients with vascular-related amputations.

OBJECTIVES: To determine the feasibility of conducting a full-scale randomised controlled trial (RCT) of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard prosthetic ankle-foot. DESIGN: Multicentre parallel group feasibility RCT. SETTING: Five prosthetics centres in England recruiting from July 2018 to August 2019. PARTICIPANTS: Adults aged ≥50 years with a vascular-related or non-traumatic transtibial amputation for 1 year or longer, categorised as having 'limited community mobility' and using a non-self-aligning ankle-foot. INTERVENTION: Participants were randomised into one of two groups for 12 weeks: self-aligning prosthetic ankle-foot or existing non-self-aligning prosthetic ankle-foot. OUTCOMES: Feasibility measures: recruitment, consent and retention rates; and completeness of questionnaire and clinical assessment datasets across multiple time points. Feasibility of collecting daily activity data with wearable technology and health resource use data with a bespoke questionnaire. RESULTS: Fifty-five participants were randomised (61% of the target 90 participants): n=27 self-aligning ankle-foot group, n=28 non-self-aligning ankle-foot group. Fifty-one participants were included in the final analysis (71% of the target number of participants). The consent rate and retention at final follow-up were 86% and 93%, respectively. The average recruitment rate was 1.25 participants/site/month (95% CI 0.39 to 2.1). Completeness of questionnaires ranged from 89%-94%, and clinical assessments were 92%-95%, including the activity monitor data. The average completion rates for the EQ-5D-5L and bespoke resource use questionnaire were 93% and 63%, respectively. CONCLUSIONS: This feasibility trial recruited and retained participants who were categorised as having 'limited community mobility' following a transtibial amputation. The high retention rate of 93% indicated the trial was acceptable to participants and feasible to deliver as a full-scale RCT. The findings support a future, fully powered evaluation of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard non-self-aligning version with some adjustments to the trial design and delivery. TRIAL REGISTRATION NUMBER: ISRCTN15043643.

Hull early walking aid for rehabilitation of transtibial amputees--randomized controlled trial (HEART).

PURPOSE: To compare articulated and nonarticulated early walking aids (EWAs) for clinical and quality-of-life outcomes in transtibial amputees. METHODS: Patients undergoing lower limb amputation in a tertiary-care vascular surgical unit were screened over a 4-year period. Recruited patients were randomized to receive articulated amputee mobility aid (AMA) or nonarticulated pneumatic postamputation mobility aid (PPAMA) during early rehabilitation. Primary (10-meter walking velocity) and secondary clinical (number and duration of physiotherapy treatments during EWA/prosthesis use) and quality-of-life (SF-36) outcome measures were recorded at five standardized assessment visits. Inter-group and intra-group analyses were performed. RESULTS: Two hundred seventy-two patients were screened and 29 transtibial amputees (median age, 56 years) were recruited (14/treatment arm). No significant difference was seen in demographics and comorbidities at baseline. Inter-group analysis: Median 10-meter walking velocity was significantly (Mann-Whitney, P = .020) faster in the PPAMA group (0.245 m/s, interquartile range [IQR] 0.218-0.402 m/s) compared with the AMA group (0.165 m/s; IQR, 0.118-0.265 m/s) at visit 1. However, there was no difference between the groups at any other visit. Similarly, the number of treatments using EWA was significantly (P = .045) lower in the PPAMA group (5.0; IQR, 3.5-8.0) compared with the AMA group (6.0; IQR, 6.0-10.5). No difference was observed between the groups in duration of physiotherapy or SF-36 domain and summary scores. Intra-group analysis: Both treatment groups showed significant improvement in 10-meter walking velocity (Friedman test; AMA P = .001; PPAMA P = .007); however, other clinical outcomes did not show any statistically significant improvement. Only physical function domain of SF-36 demonstrated significant improvement (Friedman test; AMA P = .037; PPAMA P = .029). CONCLUSIONS: There is no difference in clinical and QOL outcomes between articulated and nonarticulated EWAs in rehabilitation of transtibial amputees.