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A Challenge-Based Approach to Body Weight-Supported Treadmill Training Poststroke: Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Body weight support treadmill training protocols in conjunction with other modalities are commonly used to improve poststroke balance and walking function. However, typical body weight support paradigms tend to use consistently stable balance conditions, often with handrail support and or manual assistance. OBJECTIVE:In this paper, we describe our study protocol, which involved 2 unique body weight support treadmill training paradigms of similar training intensity that integrated dynamic balance challenges to help improve ambulatory function post stroke. The first paradigm emphasized walking without any handrails or manual assistance, that is, hands-free walking, and served as the control group, whereas the second paradigm incorporated practicing 9 essential challenging mobility skills, akin to environmental barriers encountered during community ambulation along with hands-free walking (ie hands-free + challenge walking). METHODS:We recruited individuals with chronic poststroke hemiparesis and randomized them to either group. Participants trained for 6 weeks on a self-driven, robotic treadmill interface that provided body weight support and a safe gait-training environment. We assessed participants at pre-, mid- and post 6 weeks of intervention-training, with a 6-month follow-up. We hypothesized greater walking improvements in the hands-free + challenge walking group following training because of increased practice opportunity of essential mobility skills along with hands-free walking. RESULTS:We assessed 77 individuals with chronic hemiparesis, and enrolled and randomized 30 individuals poststroke for our study (hands-free group=19 and hands-free + challenge walking group=20) from June 2012 to January 2015. Data collection along with 6-month follow-up continued until January 2016. Our primary outcome measure is change in comfortable walking speed from pre to post intervention for each group. We will also assess feasibility, adherence, postintervention efficacy, and changes in various exploratory secondary outcome measures. Additionally, we will also assess participant responses to a study survey, conducted at the end of training week, to gauge each group's training experiences. CONCLUSIONS:Our treadmill training paradigms, and study protocol represent advances in standardized approaches to selecting body weight support levels without the necessity for using handrails or manual assistance, while progressively providing dynamic challenges for improving poststroke ambulatory function during rehabilitation. TRIAL REGISTRATION:ClinicalTrials.gov NCT02787759; https://clinicaltrials.gov/ct2/show/NCT02787759 (Archived by Webcite at http://www.webcitation.org/6yJZCrIea).

SUBMITTER: Naidu A

PROVIDER: S-EPMC5958283 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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A Challenge-Based Approach to Body Weight-Supported Treadmill Training Poststroke: Protocol for a Randomized Controlled Trial.

Naidu Avantika A Brown David D Roth Elliot E

JMIR research protocols 20180503 5

<h4>Background</h4>Body weight support treadmill training protocols in conjunction with other modalities are commonly used to improve poststroke balance and walking function. However, typical body weight support paradigms tend to use consistently stable balance conditions, often with handrail support and or manual assistance.<h4>Objective</h4>In this paper, we describe our study protocol, which involved 2 unique body weight support treadmill training paradigms of similar training intensity that ...[more]

PMID: 29724706

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Project description:Locomotor training, including the use of body-weight support in treadmill stepping, is a physical therapy intervention used to improve recovery of the ability to walk after stroke. The effectiveness and appropriate timing of this intervention have not been established.We stratified 408 participants who had had a stroke 2 months earlier according to the extent of walking impairment--moderate (able to walk 0.4 to <0.8 m per second) or severe (able to walk <0.4 m per second)--and randomly assigned them to one of three training groups. One group received training on a treadmill with the use of body-weight support 2 months after the stroke had occurred (early locomotor training), the second group received this training 6 months after the stroke had occurred (late locomotor training), and the third group participated in an exercise program at home managed by a physical therapist 2 months after the stroke (home-exercise program). Each intervention included 36 sessions of 90 minutes each for 12 to 16 weeks. The primary outcome was the proportion of participants in each group who had an improvement in functional walking ability 1 year after the stroke.At 1 year, 52.0% of all participants had increased functional walking ability. No significant differences in improvement were found between early locomotor training and home exercise (adjusted odds ratio for the primary outcome, 0.83; 95% confidence interval [CI], 0.50 to 1.39) or between late locomotor training and home exercise (adjusted odds ratio, 1.19; 95% CI, 0.72 to 1.99). All groups had similar improvements in walking speed, motor recovery, balance, functional status, and quality of life. Neither the delay in initiating the late locomotor training nor the severity of the initial impairment affected the outcome at 1 year. Ten related serious adverse events were reported (occurring in 2.2% of participants undergoing early locomotor training, 3.5% of those undergoing late locomotor training, and 1.6% of those engaging in home exercise). As compared with the home-exercise group, each of the groups receiving locomotor training had a higher frequency of dizziness or faintness during treatment (P=0.008). Among patients with severe walking impairment, multiple falls were more common in the group receiving early locomotor training than in the other two groups (P=0.02).Locomotor training, including the use of body-weight support in stepping on a treadmill, was not shown to be superior to progressive exercise at home managed by a physical therapist. (Funded by the National Institute of Neurological Disorders and Stroke and the National Center for Medical Rehabilitation Research; LEAPS ClinicalTrials.gov number, NCT00243919.).

Project description:Although task-oriented training has been shown to improve walking outcomes after stroke, it is not yet clear whether one task-oriented approach is superior to another. The purpose of this study is to compare the effectiveness of the Motor Learning Walking Program (MLWP), a varied overground walking task program consistent with key motor learning principles, to body-weight-supported treadmill training (BWSTT) in community-dwelling, ambulatory, adults within 1 year of stroke.A parallel, randomized controlled trial with stratification by baseline gait speed will be conducted. Allocation will be controlled by a central randomization service and participants will be allocated to the two active intervention groups (1:1) using a permuted block randomization process. Seventy participants will be assigned to one of two 15-session training programs. In MLWP, one physiotherapist will supervise practice of various overground walking tasks. Instructions, feedback, and guidance will be provided in a manner that facilitates self-evaluation and problem solving. In BWSTT, training will emphasize repetition of the normal gait cycle while supported over a treadmill, assisted by up to three physiotherapists. Outcomes will be assessed by a blinded assessor at baseline, post-intervention and at 2-month follow-up. The primary outcome will be post-intervention comfortable gait speed. Secondary outcomes include fast gait speed, walking endurance, balance self-efficacy, participation in community mobility, health-related quality of life, and goal attainment. Groups will be compared using analysis of covariance with baseline gait speed strata as the single covariate. Intention-to-treat analysis will be used.In order to direct clinicians, patients, and other health decision-makers, there is a need for a head-to-head comparison of different approaches to active, task-related walking training after stroke. We hypothesize that outcomes will be optimized through the application of a task-related training program that is consistent with key motor learning principles related to practice, guidance and feedback.ClinicalTrials.gov # NCT00561405.

Project description:BackgroundBody weight supported treadmill training (BWSTT) is a frequently used approach for restoring the ability to walk after spinal cord injury (SCI). However, the duration of BWSTT is usually limited by fatigue of the therapists and patients. Robotic-assisted body weight supported treadmill training (RABWSTT) was developed to tackle the aforesaid limitation. Currently, limited randomized controlled trials are available to investigate its effectiveness, especially on cardiopulmonary function. The aim of this two-arm, parallel-group randomized controlled trial is to examine the feasibility of adapting an EMG-biofeedback system for assist-as-needed RABWSTT and its effects on walking and cardiopulmonary function in people with SCI.MethodsSixteen incomplete SCI subjects were recruited and randomly allocated into an intervention group or control group. The intervention group received 30 min of RABWSTT with EMG biofeedback system over the vastus lateralis muscle to enhance active participation. Dose equivalent passive lower limbs mobilization exercise was provided to subjects in the control group.ResultsSignificant time-group interaction was found in the Walking Index for Spinal Cord Injury version II (WISCI II) (p = 0.020), Spinal Cord Independence Measure version III (SCIM III) mobility sub-score (p < 0.001), bilateral symmetry (p = 0.048), maximal oxygen consumption (p = 0.014) and peak expiratory flow rate (p = 0.048). Wilcoxon signed-rank test showed that the intervention group had significant improvement in the above-mentioned outcomes after the intervention except WISCI II, which also yielded marginal significance level.ConclusionThe present study demonstrated that the use of EMG-biofeedback RABWSTT enhanced the walking performance for SCI subjects and improve cardiopulmonary function. Positive outcomes reflect that RABSTT training may be able to enhance their physical fitness.Trial registrationThe study protocol was approved by the Research Ethics Committee (Kowloon Central/ Kowloon East), Hospital Authority on 6 December 2013, and the Human Subjects Ethics Sub-committee of The Hong Kong Polytechnic University on 15 May 2013, with reference numbers KC/KC-13-0181/ER-2 and HSEARS20130510002 respectively. The study was registered in ClinicalTrials.gov on 20 November 2013, with reference number NCT01989806 .).

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

A Challenge-Based Approach to Body Weight-Supported Treadmill Training Poststroke: Protocol for a Randomized Controlled Trial.

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A Challenge-Based Approach to Body Weight-Supported Treadmill Training Poststroke: Protocol for a Randomized Controlled Trial.

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