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NCT02667392 · ClinicalTrials.gov registry record · Phase 1
Biofeedback to Increase Propulsion During Walking After Stroke
A Phase 1 study of Stroke, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT02667392: Completed Phase 1 study of Stroke, sponsored by VA Office of Research and Development.
NCT02667392 is a Phase 1 study of Stroke that has completed, run by VA Office of Research and Development. The registered enrollment target is 11 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02667392, a Phase 1 study of Stroke, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88 million for follow-up care over 6 months post-stroke. Rehabilitation of walking ability contributes to these costs. To "walk again" is the number one stated goal for Veterans who have had a stroke. Teaching patients post-stroke to use their weak leg while they are regaining walking function and to not compensate by over-using their strong leg is necessary to restore safe, efficient walking ability. This project will determine if providing biofeedback (an audible tone) from pressure-sensitive shoe insole sensors, that encourage use of the weaker leg during walking training, in addition to therapists' feedback, will help Veterans regain use of their weak leg, improve their endurance and improve their balance when walking in challenging environments.
Primary Outcome
The propulsive impulse will be derived from the time integral of the positive anterior-posterior ground reaction force for the paretic leg normalized to Body Weight.
Conditions Studied
Interventions
- PROCEDURE Gait Training with Biofeedback
- PROCEDURE Gait Training with Verbal Feedback
Study Locations (1)
Florida
- North Florida/South Georgia Veterans Health System, Gainesville, FL - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-10-02 |
| Est. Completion | 2019-09-30 |
| Phase | Phase 1 |
What the finished NCT02667392 record still lists
NCT02667392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Gait Training with Biofeedback is the first listed.
NCT02667392 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02667392 about?
NCT02667392 is a clinical study titled "Biofeedback to Increase Propulsion During Walking After Stroke". Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88 million for follow-up care over 6 months post-stroke. Rehabilitation of walking ability contributes to these costs. ...
What is the current status of trial NCT02667392?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2017-10-02. Estimated completion is 2019-09-30.
What conditions does trial NCT02667392 study?
This clinical trial studies the following conditions: Stroke.
What interventions are being tested in trial NCT02667392?
The interventions under investigation include: Gait Training with Biofeedback (PROCEDURE), Gait Training with Verbal Feedback (PROCEDURE).
Who is sponsoring clinical trial NCT02667392?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02667392 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stroke
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02667392's enrollment target sits among peer trials
11 409th of 454 higher than 41 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke 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.
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