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

Avantika Naidu,Elliot Roth,David Brown

doi:10.2196/resprot.9308

Avantika Naidu, Elliot Roth + Show 1 more

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https://doi.org/10.2196/resprot.9308

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Abstract

BackgroundBody 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.ObjectiveIn 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).MethodsWe 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.ResultsWe 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.ConclusionsOur 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 RegistrationClinicalTrials.gov NCT02787759; https://clinicaltrials.gov/ct2/show/NCT02787759 (Archived by Webcite at http://www.webcitation.org/6yJZCrIea)

Highlights

BackgroundStroke continues to remain the leading cause of long-term neurological disability in the United States [1]
We assessed 77 individuals with chronic hemiparesis, and enrolled and randomized 30 individuals poststroke for our study from June 2012 to January 2015
We conducted a 6-week, single-blinded, randomized, and parallel-arm study to examine the effects of 2 intent-driven, body weight support (BWS) treadmill training intervention groups (ie, hands-free HF+C (HF) training, and challenge (C) with HF (HF+C) training), on improving balance and functional walking outcomes in community-dwelling chronic stroke survivors, with mild-to-moderate hemiparetic gait impairments

Summary

Introduction

BackgroundStroke continues to remain the leading cause of long-term neurological disability in the United States [1]. Altered hemiparetic motor control causes balance and gait impairments, which result in asymmetric, slow (ie, 0.1 to 0.8 m/s), and inefficient walking patterns [3,4,5] Such walking patterns place stroke survivors at a greater fall risk, with ambulatory stroke survivors being twice as likely to experience falls compared with elderly individuals [6,7]. Along with generalized deconditioning, comorbidity burden, and lack of social support and self-confidence, confines stroke survivors to sedentary lifestyles [8] Such lifestyles limit participation in daily activities and predispose stroke survivors to secondary health conditions that negatively impact their overall quality of life [9]. Typical body weight support paradigms tend to use consistently stable balance conditions, often with handrail support and or manual assistance

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