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NCT05315310 · ClinicalTrials.gov registry record · NA
Robotic Exosuit Augmented Locomotion (REAL) in the Clinic and Community
A NA study, sponsored by Boston University Charles River Campus.
- Completed
- Registry status
- NA
- Development phase
- 26
- Enrollment target
NCT05315310 is a NA study that has completed, run by Boston University Charles River Campus. The registered enrollment target is 26 participants.
The verdict
NCT05315310, a NA study, has completed, sponsored by Boston University Charles River Campus.
- COMPLETED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
Study Summary
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. This study is a single-arm mechanistic clinical trial that will examine clinical and physiological factors that determine response to the intervention. This study will assist in informing best candidates and outcomes for future randomized controlled trials.
Interventions
- DEVICE Soft Exosuit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2022-03-14 |
| Est. Completion | 2023-07-19 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05315310
The ClinicalTrials.gov registry entry for NCT05315310 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University Charles River Campus, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Soft Exosuit is the first listed.
NCT05315310 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05315310 about?
NCT05315310 is a clinical study titled "Robotic Exosuit Augmented Locomotion (REAL) in the Clinic and Community". 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-restorativ...
What is the current status of trial NCT05315310?
This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2022-03-14. Estimated completion is 2023-07-19.
What interventions are being tested in trial NCT05315310?
The interventions under investigation include: Soft Exosuit (DEVICE).
Who is sponsoring clinical trial NCT05315310?
This trial is sponsored by Boston University Charles River Campus, which has 104 total clinical trials registered on ClinicalTrials.gov.
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