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Real-world vibration feedback gait retraining for Chronic Ankle Instability (RWVF Trial)

Q: Are individuals aged under 70 eligible for enrollment in this experiment?

<p>This trial has established that participants should be between 18 and 35 years of age. There are also 3 studies dedicated to those under the legal age, as well as 6 trials for patients over 65 years old.</p>

N/A

Waitlist Available

Led By Kimmery Migel, PT, DPT

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cop location during walking will be measured at baseline, within 72 hours of completing the intervention (p-2), 1 week after the intervention (f-1), 1 month after the intervention (f-4).

Awards & highlights

RWVF Trial Summary

This trial is testing whether two weeks of gait retraining with vibration feedback can restore normal walking mechanics in people with chronic ankle instability, which causes abnormal walking that can lead to lifelong disability.

RWVF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cop location during walking will be measured at baseline, within 72 hours of completing the intervention (p-2), 1 week after the intervention (f-1), 1 month after the intervention (f-4).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cop location during walking will be measured at baseline, within 72 hours of completing the intervention (p-2), 1 week after the intervention (f-1), 1 month after the intervention (f-4).

This trial's timeline: 3 weeks for screening, Varies for treatment, and cop location during walking will be measured at baseline, within 72 hours of completing the intervention (p-2), 1 week after the intervention (f-1), 1 month after the intervention (f-4). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Immediate and retained changes in the center of pressure location under the foot at initial contact within the chronic ankle instability group in response to 2-weeks of RWVF gait retraining.

Secondary outcome measures

Differences between the COP location in people with CAI following 2-weeks of RWVF gait retraining and the COP location in healthy controls.

Immediate and retained changes in the center of pressure location under the foot from 20% to 100% of the walking stance phase within the chronic ankle instability group in response to 2-weeks of RWVF gait retraining.

RWVF Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

All CAI participants will complete the same intervention and will walk 6, 1-mile paths in the real wold (ie: around campus) with vibration feedback within 2 weeks of baseline assessment. A study team member will accompany each participant during each training.

Group II: Healthy ControlActive Control1 Intervention

Posttest data from CAI participants will be compared to de-identified healthy control data collected as part of a previous study. Healthy control participants completed a single research session to collect walking biomechanics using the same methods as this project. They received no further follow up or intervention and the inclusion/ exclusion criteria for this group match those of the chronic ankle instability cohort.

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Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,506 Previous Clinical Trials

4,190,541 Total Patients Enrolled

Academy of Orthopaedic Physical TherapyUNKNOWN

1 Previous Clinical Trials

60 Total Patients Enrolled

Kimmery Migel, PT, DPTPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants does this trial have a capacity for?

"Affirmative. According to data hosted on clinicaltrials.gov, this medical trial is actively recruiting patients since its initial posting date of June 9th 2022 and latest edit on August 15th 2022. The study requires 20 participants from one location."

Answered by AI

Are recruitment efforts ongoing for this research endeavor?

"As indicated on clinicaltrials.gov, this investigation is presently looking for suitable participants and was initially posted June 9th 2022, with the most recent update having occurred August 15th of the same year."

Answered by AI

Who is eligible to join the trial cohort?

"This clinical investigation is recruiting 20 young adults aged 18-35 who have articulated ankle instability. To qualify, they must additionally score ≥ 11 on the Identification of Functional Ankle Instability (IdFAI) and report functional limitations with a FAAM Activities of Daily Living subscale rating < 90% and Sport subscale reading below 80%. Additionally, their joint instability must be attributable to at least one major sprain occurring over 12 months before enrolling."

Answered by AI

Are individuals aged under 70 eligible for enrollment in this experiment?

"This trial has established that participants should be between 18 and 35 years of age. There are also 3 studies dedicated to those under the legal age, as well as 6 trials for patients over 65 years old."

Answered by AI

Recent research and studies

Journal of Athletic TrainingJournal

Selection Criteria for Patients with Chronic Ankle Instability in Controlled Research: A Position Statement of the International Ankle Consortium

Gribble, Phillip A., Eamonn Delahunt, Christopher M. Bleakley, Brian Caulfield, Carrie L. Docherty, Daniel Tik-Pui Fong, François Fourchet, et al.. 2014. “Selection Criteria for Patients with Chronic Ankle Instability in Controlled Research: A Position Statement of the International Ankle Consortium”. Journal of Athletic Training. Journal of Athletic Training/NATA. doi:10.4085/1062-6050-49.1.14.

Osteoarthritis and CartilageJournal

T1ρ MRI of the Talar Articular Cartilage Is Increased in Those with Chronic Ankle Instability

Wikstrom, E.A., K. Song, J.N. Tennant, K.M. Dederer, C. Paranjape, and B. Pietrosimone. 2019. “T1ρ MRI of the Talar Articular Cartilage Is Increased in Those with Chronic Ankle Instability”. Osteoarthritis and Cartilage. Elsevier BV. doi:10.1016/j.joca.2018.12.019.

Journal of Orthopaedic & Sports Physical TherapyJournal

Feedback and Feedforward Control During Walking in Individuals with Chronic Ankle Instability

Yen, Sheng-Che, Marie B. Corkery, Amy Donohoe, Maddison Grogan, and Yi-Ning Wu. 2016. “Feedback and Feedforward Control During Walking in Individuals with Chronic Ankle Instability”. Journal of Orthopaedic & Sports Physical Therapy. Journal of Orthopaedic & Sports Physical Therapy (JOSPT). doi:10.2519/jospt.2016.6403.

Gait & PostureJournal