Stopped: Investigators elected to implement a staged approach, conducting a mechanistic clinical trial first before proceeding with a randomized controlled trial. Consequently, this study is withdrawn.
Previous studies of the exosuit technology have culminated in strong evidence for the gait-restorative effects of soft robotic exosuits for patients post-stroke by means of substitution for lost function. The present study builds on this work by suggesting that an exosuit's immediate gait-restorative effects can be leveraged during high intensity gait training to produce long-lasting gait restoration. Current gait training efforts are focused on either quality or intensity. They focus on gait quality often by reducing the training intensity to allow patients to achieve a more normal gait. In contrast, efforts focused on training intensity push participants without focusing on the quality of their movements. These intervention paradigms generally fail to substantially impact community mobility. In this study, the investigators posit that exosuits can uniquely enable an integration of these paradigms (ie, high intensity gait training that promotes quality of movements). For this protocol, exosuits developed in collaboration with an industry partner, ReWalkâ„¢ Robotics will be used. To evaluate the effects of REAL gait training, the investigators will use clinical measures of motor and gait function, locomotor mechanics and energetics, and physiologic measures that may infer on motor learning. The spectrum of behavioral and physiologic data that we will collect will enable us to understand more comprehensively the gait-restorative effects of REAL.
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6-Minute Walk Test (6MWT)
Timeframe: Baseline (Pre-training Evaluation)
6-Minute Walk Test (6MWT)
Timeframe: Post-training Evaluation (up to 6 weeks)
6-Minute Walk Test (6MWT)
Timeframe: Retention Evaluation (up to 4 weeks post-washout)
10-Meter Walk Test (10MWT)
Timeframe: Baseline (Pre-training Evaluation)
10-Meter Walk Test (10MWT)
Timeframe: Post-training Evaluation (up to 6 weeks)
10-Meter Walk Test (10MWT)
Timeframe: Retention Evaluation (up to 4 weeks post-washout)