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New treatment option for Ankle Sprains
Official title Auditory Biofeedback Gait Training Individuals With Chronic Ankle Instability
ClinicalTrials.gov ID: NCT06868316
What this study is testing
- What it's testing
- The goal of this randomized clinical controlled trial is examine the effects of gait training with auditory biofeedback (AudFB) on gait biomechanics, clinical measures of ankle joint health, and patient-centered outcomes. The following specific aims will achieve this objective: Specific Aim 1: Determine if a 6-week gait training with AudFB intervention improves lower extremity biomechanics compared to a Control condition in participants with CAI.
- Time commitment: about 6 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- Physically active adults (defined as participants reporting a score of =4 on the National Aeronautics and Space Administration (NASA) Activity...
- History of ankle sprain
- 2 episodes of "giving way" in the past 6-months
- must answer "yes" to =5 questions on the Ankle Instability Instrument (AII) and =11 on the Identification of Functional Ankle Instability (IdFAI)
You likely can't join if
- an ankle sprain in the previous four weeks or lower extremity neuromusculoskeletal injury other than to the ankle in the last 12 months
- history of surgery in the lower extremity
- fracture to the lower extremity in the past 12 months or a fracture that required open-reduction internal fixation
- history of neurological disease, vestibular or visual disturbance or any other pathology that would impair sensorimotor performance or gait
- current participation in a formal ankle joint rehabilitation program
- a concussion in the last 12 months
See the full eligibility criteria
- Physically active adults (defined as participants reporting a score of =4 on the National Aeronautics and Space Administration (NASA) Activity Instrument and indicating they can run for at least 20 consecutive minutes)
- History of ankle sprain
- 2 episodes of "giving way" in the past 6-months
- must answer "yes" to =5 questions on the Ankle Instability Instrument (AII) and =11 on the Identification of Functional Ankle Instability (IdFAI)
- an ankle sprain in the previous four weeks or lower extremity neuromusculoskeletal injury other than to the ankle in the last 12 months
- history of surgery in the lower extremity
- fracture to the lower extremity in the past 12 months or a fracture that required open-reduction internal fixation
- history of neurological disease, vestibular or visual disturbance or any other pathology that would impair sensorimotor performance or gait
- current participation in a formal ankle joint rehabilitation program
- a concussion in the last 12 months
- report a cardiovascular, metabolic, or renal disease, or signs and symptoms that suggest such condition or have been told by a medical provider not to engage in vigorous physical activity (such as running).
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, United States
- Charlotte, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, United States; Charlotte, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.