Robotic Exosuit Augmented Locomotion (REAL)

Withdrawn before enrolling · Not applicable

Conditions studied: Stroke

In brief

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, ReWalk™ 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.

Key facts

Study ID

NCT04818424

Run by

Lou Awad, PT, DPT, PhD

People needed

0

Starts

2021-02-24

Expected to finish

2022-07-01

Last updated by the study team

2026-03-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 - 80 years old
• Stroke event occurred at least 6 months ago
• Observable gait deficits
• Gait speed equal to or less than 1 m/s
• Able to walk without the support of another person for at least 6 minutes (may use an assistive device as needed, but without use of an ankle foot orthosis or brace)
• Passive ankle dorsiflexion range of motion to neutral with the knee extended (i.e., able to achieve an angle of 90 degrees between the shank and the foot)
• Resting heart rate between 40 - 100 bpm, inclusive
• Resting blood pressure between 90/60 and 170/90 mmHg, inclusive

You may not qualify if…

• Score of >1 on question 1b and >0 on question 1c on the NIH Stroke Scale
• Inability to communicate with investigators
• Neglect or hemianopia
• Actively receiving physical therapy for walking
• History of cerebellar strokes
• Known recurring or repeating strokes
• Unexplained dizziness in the last 6 months
• Pressure ulcers or skin wounds located at human-device interface sites
• Other medical, orthopedic, and neurological conditions that prevent full participation in the research

Where it is running

• Harvard University — Boston, Massachusetts, United States
• Boston University — Boston, Massachusetts, United States
• Spaulding Rehabilitation Hospital — Charlestown, Massachusetts, United States

Full record on ClinicalTrials.gov

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