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Feedback-Focused Rehabilitation for Ankle Injury
N/A
Recruiting
Research Sponsored by University of North Carolina, Charlotte
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 immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Awards & highlights
Study Summary
This trial will test if a 4-week rehabilitation program that includes feedback can improve ankle inversion kinematics and self-reported function.
Who is the study for?
This trial is for people who have chronic ankle instability (CAI) from past ankle sprains but haven't had a recent injury or surgery. They should be somewhat active, doing physical activities at least three times a week, and not currently receiving medical treatment for CAI.Check my eligibility
What is being tested?
The study tests if different types of feedback during rehabilitation can improve walking biomechanics and self-reported function in CAI patients. It compares visual, auditory, and video feedback against no feedback over a 4-week program with 12 sessions.See study design
What are the potential side effects?
Since the interventions involve non-invasive feedback methods during movement training, significant side effects are not anticipated. However, participants may experience fatigue or discomfort due to the exercises involved in the rehabilitation program.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes from baseline in lower extremity kinematics and kinetics during walking
Changes from baseline in self-reported ankle function
Secondary outcome measures
Changes from baseline in ankle maximum voluntary isometric strength
Changes from baseline in ankle range of motion measured in degrees
Changes from baseline in static and dynamic balance
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: InFOCUS VisualExperimental Treatment1 Intervention
Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools and will receive internal focus of attention visual feedback via video.
Group II: ExFOCUS VisualExperimental Treatment1 Intervention
Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools and will receive external focus of attention visual feedback.
Group III: ExFOCUS AuditoryExperimental Treatment1 Intervention
Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools and will receive auditory feedback.
Group IV: NoFeedbackActive Control1 Intervention
Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools and receive no feedback.
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Who is running the clinical trial?
University of North Carolina, CharlotteLead Sponsor
23 Previous Clinical Trials
13,118 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a bone or muscle injury in the last 6 weeks.I have had surgery on my ankle.I have a condition affecting my balance.I have or had a leg condition that affects my muscle control.I sprained my ankle in the last 6 weeks.I have had multiple ankle sprains over a year ago and still feel symptoms without seeking treatment.
Research Study Groups:
This trial has the following groups:- Group 1: ExFOCUS Visual
- Group 2: NoFeedback
- Group 3: InFOCUS Visual
- Group 4: ExFOCUS Auditory
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Which patients meet the criteria for participation in this experiment?
"This study seeks to recruit 100 physically active adults, aged between 18 and 40, who have endured a history of recurrent ankle sprains for over 12 months. Furthermore, all participants should be diagnosed with chronic ankle instability (CAI) through self-reported symptoms and disability that has not been addressed via treatment yet. Lastly, participants must partake in physical activity for at least 20 minutes thrice weekly."
Answered by AI
What is the aggregate amount of individuals participating in this research project?
"Affirmative. Data found on clinicaltrials.gov states that the trial, which was first posted in February 18th 2020, is still looking for volunteers to participate. A total of 100 individuals are required at one single medical centre."
Answered by AI
Does this clinical trial include elderly participants?
"This medical trial requires that all participants must be between the age of 18 and 40, in order to meet the enrollment criteria."
Answered by AI
Are there any openings in this research project at present?
"Absolutely. Clinicaltrials.gov currently displays this medical trial, which was initially posted on February 18th 2020 and last updated May 16th 2022, is actively enlisting patients for participation. Approximately 100 individuals must be enrolled from 1 site in order to reach the research's goals."
Answered by AI
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