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NCT05327244 · ClinicalTrials.gov registry record · NA
The Impact of Real-World Vibration Feedback Gait Retraining on Gait Biomechanics in People With Chronic Ankle Instability
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT05327244 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 20 participants.
The verdict
NCT05327244, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
People with chronic ankle instability (CAI) demonstrate altered gait or walking mechanics which cause people to walk on the outside of their foot and increases the risk of additional ankle sprains, abnormal cartilage strain, and early joint degeneration. Evidence indicates that common treatments for CAI do not impact gait, leaving unresolved impairments that can lead to lifelong disability. Recent lab-based gait retraining with visual and auditory feedback has immediately improved walking mechanics. However, real-world training is hypothesized to generate long-term changes by incorporating short, frequent training sessions over a variety of surfaces. These are key training parameters to produce lasting change. Pilot data using real-world vibration feedback (RW-VF) suggest that a single session immediately improves walking mechanics with changes lasting for up to 5 minutes. Despite promising initial results, there remains a critical need to determine the impact of multiple RW-VF sessions as an initial step to developing a protocol capable of long-term improvements. The purpose of this proposal is to determine the extent to which 2-weeks of RW-VF restores gait biomechanics in those with CAI. Twenty people with CAI will be enrolled and complete a two-week gait retraining protocol with vibration feedback. Walking mechanics before, immediately after, and 1 week and 4 weeks following the training will be compared. These contributions can be significant as positive results will support a paradigm shift in treatments for people with CAI and lay the foundation for large scale clinical trials aimed at optimizing long term gains. The outcomes of future research have the potential to advance evidenced based rehabilitation interventions not only for people with CAI but also for people who have sustained a variety of musculoskeletal injuries as there is strong evidence that other lower extremity pathologies cause lifelong limitations, including changes in walking mechanics which
Interventions
- OTHER Real-world vibration feedback gait retraining
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-06-09 |
| Est. Completion | 2023-04-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05327244
The ClinicalTrials.gov registry entry for NCT05327244 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Real-world vibration feedback gait retraining is the first listed.
NCT05327244 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05327244 about?
NCT05327244 is a clinical study titled "The Impact of Real-World Vibration Feedback Gait Retraining on Gait Biomechanics in People With Chronic Ankle Instability". People with chronic ankle instability (CAI) demonstrate altered gait or walking mechanics which cause people to walk on the outside of their foot and increases the risk of additional ankle sprains, abnormal cartilage strain, and early joint degeneration. Evidence indicates that common treatments for...
What is the current status of trial NCT05327244?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2022-06-09. Estimated completion is 2023-04-06.
What interventions are being tested in trial NCT05327244?
The interventions under investigation include: Real-world vibration feedback gait retraining (OTHER).
Who is sponsoring clinical trial NCT05327244?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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