Dataset Information

Treadmill training to improve mobility for people with sub-acute stroke: a phase II feasibility randomized controlled trial.

ABSTRACT:

Objective

This phase II study investigated the feasibility and potential effectiveness of treadmill training versus normal gait re-education for ambulant and non-ambulant people with sub-acute stroke delivered as part of normal clinical practice.

Design

A single-blind, feasibility randomized controlled trial.

Setting

Four hospital-based stroke units.

Subjects

Participants within three months of stroke onset.

Interventions

Participants were randomized to treadmill training (minimum twice weekly) plus normal gait re-education or normal gait re-education only (control) for up to eight weeks.

Main measures

Measures were taken at baseline, after eight weeks of intervention and at six-month follow-up. The primary outcome was the Rivermead Mobility Index. Other measures included the Functional Ambulation Category, 10-metre walk, 6-minute walk, Barthel Index, Motor Assessment Scale, Stroke Impact Scale and a measure of confidence in walking.

Results

In all, 77 patients were randomized, 39 to treadmill and 38 to control. It was feasible to deliver treadmill training to people with sub-acute stroke. Only two adverse events occurred. No statistically significant differences were found between groups. For example, Rivermead Mobility Index, median (interquartile range (IQR)): after eight weeks treadmill 5 (4-9), control 6 (4-11) p?=?0.33; or six-month follow-up treadmill 8.5 (3-12), control 8 (6-12.5) p?=?0.42. The frequency and intensity of intervention was low.

Conclusion

Treadmill training in sub-acute stroke patients was feasible but showed no significant difference in outcomes when compared to normal gait re-education. A large definitive randomized trial is now required to explore treadmill training in normal clinical practice.

SUBMITTER: Baer GD

PROVIDER: S-EPMC5777545 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Publications

Treadmill training to improve mobility for people with sub-acute stroke: a phase II feasibility randomized controlled trial.

Baer Gillian D GD Salisbury Lisa G LG Smith Mark T MT Pitman Jane J Dennis Martin M

Clinical rehabilitation 20170721 2

<h4>Objective</h4>This phase II study investigated the feasibility and potential effectiveness of treadmill training versus normal gait re-education for ambulant and non-ambulant people with sub-acute stroke delivered as part of normal clinical practice.<h4>Design</h4>A single-blind, feasibility randomized controlled trial.<h4>Setting</h4>Four hospital-based stroke units.<h4>Subjects</h4>Participants within three months of stroke onset.<h4>Interventions</h4>Participants were randomized to treadm ...[more]

PMID: 28730849

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Project description:BackgroundWe previously characterized hemisphere-specific motor control deficits in the ipsilesional, less-impaired arm of unilaterally lesioned stroke survivors. Our preliminary data indicate these deficits are substantial and functionally limiting in patients with severe paresis.MethodsWe have designed an intervention ("IPSI") to remediate the hemisphere-specific deficits in the ipsilesional arm, using a virtual-reality platform, followed by manipulation training with a variety of real objects, designed to facilitate generalization and transfer to functional behaviors encountered in the natural environment. This is a 2-site (primary site - Penn State College of Medicine, secondary site - University of Southern California), two-group randomized intervention with an experimental group, which receives unilateral training of the ipsilesional arm throughout 3 one-hour sessions per week for 5 weeks, through our Virtual Reality and Manipulation Training (VRMT) protocol. Our control group receives a conventional intervention on the contralesional arm, 3 one-hour sessions per week for 5 weeks, guided by recently released practice guidelines for upper limb rehabilitation in adult stroke. The study aims to include a total of 120 stroke survivors (60 per group) whose stroke was in the territory of the middle cerebral artery (MCA) resulting in severe upper-extremity motor impairments. Outcome measures (Primary: Jebsen-Taylor Hand Function Test, Fugl-Meyer Assessment, Abilhand, Barthel Index) are assessed at five evaluation points: Baseline 1, Baseline 2, immediate post-intervention (primary endpoint), and 3-weeks (short-term retention) and 6-months post-intervention (long-term retention). We hypothesize that both groups will improve performance of the targeted arm, but that the ipsilesional arm remediation group will show greater improvements in functional independence.DiscussionThe results of this study are expected to inform upper limb evaluation and treatment to consider ipsilesional arm function, as part of a comprehensive physical rehabilitation strategy that includes evaluation and remediation of both arms.Trial registrationThis study is registered with ClinicalTrials.gov (Registration ID: NCT03634397 ; date of registration: 08/16/2018).

Project description:BACKGROUND:Aerobic training has the potential to restore function, stimulate brain repair, and reduce inflammation in people with Multiple Sclerosis (MS). However, disability, fatigue, and heat sensitivity are major barriers to exercise for people with MS. We aimed to determine the feasibility of conducting vigorous harness-supported treadmill training in a room cooled to 16?°C (10?weeks; 3times/week) and examine the longer-term effects on markers of function, brain repair, and inflammation among those using ambulatory aids. METHODS:Ten participants (9 females) aged 29 to 74?years with an Expanded Disability Status Scale ranging from 6 to 7 underwent training (40 to 65% heart rate reserve) starting at 80% self-selected walking speed. Feasibility of conducting vigorous training was assessed using a checklist, which included attendance rates, number of missed appointments, reasons for not attending, adverse events, safety hazards during training, reasons for dropout, tolerance to training load, subjective reporting of symptom worsening during and after exercise, and physiological responses to exercise. Functional outcomes were assessed before, after, and 3?months after training. Walking ability was measured using Timed 25 Foot Walk test and on an instrumented walkway at both fast and self-selected speeds. Fatigue was measured using fatigue/energy/vitality sub-scale of 36-Item Short-Form (SF-36) Health Survey, Fatigue Severity Scale, modified Fatigue Impact Scale. Aerobic fitness (maximal oxygen consumption) was measured using maximal graded exercise test (GXT). Quality-of-life was measured using SF-36 Health Survey. Serum levels of neurotrophin (brain-derived neurotrophic factor) and cytokine (interleukin-6) were assessed before and after GXT. RESULTS:Eight of the ten participants completed training (attendance rates ??80%). No adverse events were observed. Fast walking speed (cm/s), gait quality (double-support (%)) while walking at self-selected speed, fatigue (modified Fatigue Impact Scale), fitness (maximal workload achieved during GXT), and quality-of-life (physical functioning sub-scale of SF-36) improved significantly after training, and improvements were sustained after 3-months. Improvements in fitness (maximal respiratory exchange ratio and maximal oxygen consumption during GXT) were associated with increased brain-derived neurotrophic factor and decreased interleukin-6. CONCLUSION:Vigorous cool room training is feasible and can potentially improve walking, fatigue, fitness, and quality-of-life among people with moderate to severe MS-related disability. TRIAL REGISTRATION:The study was approved by the Newfoundland and Labrador Health Research Ethics Board (reference number: 2018.088) on 11/07/2018 prior to the enrollment of first participant (retrospectively registered at ClinicalTrials.gov: NCT04066972. Registered on 26 August 2019.

Project description:BackgroundExercise has failed to reduce falls in those with chronic stroke. A limitation of traditional exercise is that the motor responses needed to prevent a fall are not elicited (i.e. they lack processing specificity). Balance reactions often require compensatory steps. Therefore, interventions that target such steps have the potential to reduce falls. Computerized treadmills can deliver precise, repeatable, and challenging perturbations as part of a training protocol. The objective of this study was to develop and determine the feasibility of such training applied to those with chronic stroke. We developed the training to address specificity, appropriate duration and repetition, and progressive overloading and individualization. We hypothesized that our intervention would be acceptable, practical, safe, and demonstrate initial signs of efficacy.MethodsIn this single-arm study, thirteen individuals with chronic stroke (29-77 years old, 2-15 years post stroke) performed up to six training sessions using a computer-controlled treadmill. Each session had separate progressions focused on initial steps with the non-paretic or paretic limbs in response to anterior or posterior falls. Perturbation magnitudes were altered based on performance and tolerance. Acceptability was determined by adherence, or the number of sessions completed. Practicality was documented by the equipment, space, time, and personnel. Adverse events were documented to reflect safety. In order to determine the potential-efficacy of this training, we compared the proportion of successful recoveries and the highest perturbation magnitude achieved on the first and last sessions.ResultsThe training was acceptable, as evident by 12/13 participants completing all 6 sessions. The protocol was practical, requiring one administrator, the treadmill, and a harness. The protocol was safe, as evident by no serious or unanticipated adverse events. The protocol demonstrated promising signs of efficacy. From the first to last sessions, participants had a higher proportion of successful recoveries and progressed to larger disturbances.ConclusionsUsing a computerized treadmill, we developed an approach to fall-recovery training in individuals with chronic stroke that was specific, considered duration and repetition, and incorporated progressive overloading and individualization. We demonstrated that this training was acceptable, practical, safe, and potentially beneficial for high-functioning individuals with chronic stroke.Trial registrationRetrospectively registered at clinicaltrials.gov ( NCT03638089 ) August 20, 2018.

Project description:Background People with mobility limitations can benefit from rehabilitation programs incorporating intensive, repetitive, and task-specific exercises using digital devices such as virtual reality gaming systems, tablet and smartphone applications, and wearable devices. The Activity and MObility UsiNg Technology (AMOUNT) rehabilitation trial (n = 300) showed improvements in mobility in people using these types of digital devices in addition to their usual rehabilitation care when the intervention was provided by an additional study-funded physiotherapist. However, it is not clear if this intervention can be implemented by hospital physiotherapists with a usual clinical load. The AMOUNT Implementation trial aims to explore the feasibility of conducting a large-scale implementation trial. Methods A pragmatic, assessor blinded, feasibility hybrid type II randomized controlled trial will be undertaken at a public hospital in Australia. There will be two phases. Phase I (Implementation phase) will involve implementing the digital devices into physiotherapy practice. Physiotherapists from the rehabilitation ward will receive a multifaceted implementation strategy guided by the Capabilities, Opportunities, Motivation-Behaviour (COM-B) theoretical model. The implementation strategy includes identifying and training a clinical champion; providing digital devices and education and training; facilitating use of the devices through clinical reasoning sessions and journal clubs; and audit and feedback of exercise dosage documentation. Phase II (Trial phase) will involve randomising 30 eligible inpatients from the same ward into either usual care or usual care plus an additional 30 min or more of exercises using digital devices. This intervention will be provided by the physiotherapists who took part in the implementation phase. We will collect data on feasibility, implementation, and patient-level clinical outcomes. The three primary outcome measures are the extent to which physiotherapists document the dosage of exercises provided to participants (feasibility criteria: exercise practice sheets complete for ≥85% of all participants); ability to recruit participants; and fidelity to the protocol of using digital devices to prescribe exercises (feasibility criteria: average of ≥ 30mins per day for > 50% intervention participants). Discussion This feasibility study will provide important information to guide the planning and conduct of a future large-scale implementation trial. Trial registration Australian and New Zealand Clinical Trial Registry; ACTRN12621000938808; registered 19/07/2021. Trial sponsor: Prince of Wales Hospital. 320–346 Barker Street, Randwick, NSW, 2031, Australia. Protocol version: 6.2 7th April 2021. Supplementary Information The online version contains supplementary material available at 10.1186/s40814-023-01298-y.

Project description:Walking impairment impacts nearly 66% of stroke survivors and is a rising cause of morbidity worldwide. Despite conventional post-stroke rehabilitative care, the majority of stroke survivors experience continued limitations in their walking speed, temporospatial dynamics and walking capacity. Hence, novel and comprehensive approaches are needed to improve the trajectory of walking recovery in stroke survivors. Herein, we test the safety, feasibility and preliminary efficacy of two approaches for post-stroke walking recovery: backward locomotor treadmill training and transcutaneous spinal direct current stimulation. In this double-blinded study, 30 chronic stroke survivors (>6 months post-stroke) with mild-severe residual walking impairment underwent six 30-min sessions (three sessions/week) of backward locomotor treadmill training, with concurrent anodal (N = 19) or sham transcutaneous spinal direct current stimulation (N = 11) over the thoracolumbar spine, in a 2:1 stratified randomized fashion. The primary outcomes were: per cent participant completion, safety and tolerability of these two approaches. In addition, we collected data on training-related changes in overground walking speed, cadence, stride length (baseline, daily, 24-h post-intervention, 2 weeks post-intervention) and walking capacity (baseline, 24-h post-intervention, 2 weeks post-intervention), as secondary exploratory aims testing the preliminary efficacy of these interventions. Eighty-seven per cent (N = 26) of randomized participants completed the study protocol. The majority of the study attrition involved participants with severe baseline walking impairment. There were no serious adverse events in either the backward locomotor treadmill training or transcutaneous spinal direct current stimulation approaches. Also, both groups experienced a clinically meaningful improvement in walking speed immediately post-intervention that persisted at the 2-week follow-up. However, in contrast to our working hypothesis, anodal-transcutaneous spinal direct current stimulation did not enhance the degree of improvement in walking speed and capacity, relative to backward locomotor treadmill training + sham, in our sample. Backward locomotor treadmill training and transcutaneous spinal direct current stimulation are safe and feasible approaches for walking recovery in chronic stroke survivors. Definitive efficacy studies are needed to validate our findings on backward locomotor treadmill training-related changes in walking performance. The results raise interesting questions about mechanisms of locomotor learning in stroke, and well-powered transcutaneous spinal direct current stimulation dosing studies are needed to understand better its potential role as a neuromodulatory adjunct for walking rehabilitation.

Project description:BackgroundStroke rehabilitation often uses the motor relearning concept that require patients to perform active practice of skill-specific training and to receive feedback. Treadmill training augmented with real-time visualisation feedback and functional electrical stimulation may have a beneficial synergistic effect on motor recovery. This study aims to determine the feasibility of this kind of enhanced treadmill training for gait rehabilitation among patients after stroke. A system for dynamic visualisation of lower-limb movement based on 3-dimentional motion capture and a computer timed functional electrical stimulation system was developed. Participants received up to 20-min enhanced treadmill training instead of their over-ground gait training once or twice a week for 6 weeks at Coathill hospital, Lanarkshire, United Kingdom. Number of training sessions attended, and training duration were used to assess feasibility. Ankle kinematics in the sagittal plane of walking with and without functional electrical stimulation support of the pre-tibial muscles were also compared and used to confirm the functional electrical stimulation was triggered at the targeted time.ResultsSix patients after stroke participated in the study. The majority of participants were male (5/6) with a age range from 30 to 84 years and 4/6 had left hemiplegia. All participants suffered from brain infarction and were at least 3 months after stroke. Number of training sessions attended ranged from 5 to 12. The duration of training sessions ranged from 11 to 20 min. No serious adverse events were reported. The computerised functional electrical stimulation to the pre-tibial muscles was able to reduce plantarflexion angle during the swing phase with statistical significance (p = 0.015 at 80%; p = 0.008 at 90 and 100% of the gait cycle).ConclusionsIt is safe and feasible to use treadmill gait training augmented with real-time visual feedback and computer-controlled functional electrical stimulation with patients after stroke in routine clinical practice.Trial registrationNCT03348215. Registered 20 November 2017.

Project description:BACKGROUND:For stroke survivors, balance deficits that persist after the completion of the rehabilitation process lead to a significant risk of falls. We have recently developed a balance-assessment robot (BAR-TM) that enables assessment of balancing abilities during walking. The purpose of this study was to test feasibility of using the BAR-TM in an experimental perturbed-balance training program with a selected high-functioning stroke survivor. METHODS:A control and an individual with right-side chronic hemiparesis post-stroke were studied. The individual post-stroke underwent thirty sessions of balance-perturbed training that involved walking on an instrumented treadmill while the BAR-TM delivered random pushes to the participant's pelvis; these pushes were in various directions, at various speeds, and had various perturbation amplitudes. We assessed kinematics, kinetics, electromyography, and spatio-temporal responses to outward-directed perturbations of amplitude 60 N (before training) and 60 N and 90 N (after training) commencing on contact of either the nonparetic-left foot (LL-NP/L perturbation) or the paretic-right foot (RR-P/R perturbation) while the treadmill was running at a speed of 0.4 m/s. RESULTS:Before training, the individual post-stroke primarily responded to LL-NP/L perturbations with an in-stance response on the non-paretic leg in a similar way to the control participant. After training, the individual post-stroke added adequate stepping by making a cross-step with the paretic leg that enabled successful rejection of the perturbation at lower and higher amplitudes. Before training, the individual post-stroke primarily responded to RR-P/R perturbations with fast cross-stepping using the left, non-paretic leg while in-stance response was entirely missing. After training, the stepping with the non-paretic leg was supplemented by partially recovered ability to exercise in-stance responses on the paretic leg and this enabled successful rejection of the perturbation at lower and higher amplitudes. The assessed kinematics, kinetics, electromyography, and spatio-temporal responses provided insight into the relative share of each balancing strategy that the selected individual post-stroke used to counteract LL-NP/L and RR-P/R perturbations before and after the training. CONCLUSIONS:The main finding of this case-control study is that robot-based perturbed-balance training may be a feasible approach. It resulted in an improvement the selected post-stroke participant's ability to counteract outward-directed perturbations. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03285919 - retrospectively registered.

Project description:BACKGROUND:Treadmill training, with or without body-weight support (BWSTT), typically involves high step count, faster walking speed, and higher heart-rate intensity than overground walking training. The addition of challenging mobility skill practice may offer increased opportunities to improve walking and balance skills. Here we compare walking and balance outcomes of chronic stroke survivors performing BWSTT with BWSTT including challenging mobility skills. METHODS:Single-blind randomized clinical trial comparing two BWSTT interventions performed in a rehabilitation research laboratory facility over 6 weeks. Participants were 18+ years of age with chronic (?5 months) poststroke hemiparesis due to a cortical or subcortical ischemic or hemorrhagic stroke and walking speeds <?1.1 m/s at baseline. A hands-free group (HF; n?=?15) performed BWSTT without assistance from handrails or assistive devices, and a hands-free plus challenge group (HF?+?C; n?=?14) performed the same protocol while additionally practicing challenging mobility skills. The primary outcome was change in comfortable walking speed (CWS), with secondary outcomes of fast walk speed (FWS), six-minute walk distance, Berg Balance Scale (BBS) scores, and Activities Specific Balance Confidence (ABC) scores. RESULTS:Significant pre-post improvement of CWS (Z?=?-?4.2, p???0.0001) from a median of 0.35 m/s (range 0.10 to 1.09) to a median of 0.54 m/s (range 0.1 to 1.17), but no difference observed between groups (U?=?96.0, p?=?0.69). Pre-post improvements across all participants resulted in reclassified baseline ambulation status from sixteen to ten household ambulators, three to seven limited community ambulators, and ten to twelve community ambulators. Secondary outcomes showed similar pre-post improvements with no between-group differences. CONCLUSIONS:The addition of challenging mobility skills to a hands-free BWSTT protocol did not lead to greater improvements in CWS following 6 weeks of training. One reason for lack of group differences may be that both groups were adequately challenged by walking in an active, self-driven treadmill environment without use of handrails or assistive devices. TRIAL REGISTRATION:NCT02787759 Falls-based Training for Walking Post-Stroke (FBT); retrospectively registered June 1st, 2016.

Dataset Information

Treadmill training to improve mobility for people with sub-acute stroke: a phase II feasibility randomized controlled trial.

Objective

Design

Setting

Subjects

Interventions

Main measures

Results

Conclusion

Publications

Treadmill training to improve mobility for people with sub-acute stroke: a phase II feasibility randomized controlled trial.

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