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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: Completed NA study, sponsored by Boston University Charles River Campus.
NCT05315310 is a NA study that has completed, run by Boston University Charles River Campus. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This is test of long-distance walking function. The participant will be asked to "cover as much distance as they safely can" for 6 minutes, and total distance is the main metric from this test. This will be performed without wearing the soft exosuit (No Suit) regardless of intervention.
Interventions
- DEVICE Soft Exosuit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2022-03-14 |
| Est. Completion | 2023-07-19 |
| Phase | NA |
What the finished NCT05315310 record still lists
NCT05315310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Soft Exosuit is the first listed.
NCT05315310 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05315310's enrollment target sits among peer trials
26 1710th of 2000 higher than 289 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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