Auditory Biofeedback Gait Training Individuals With Chronic Ankle Instability
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorDanielle Torp
About this trial
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. * Specific Aim 2: Determine if a 6-week gait training with AudFB reduces talar cartilage deformation compared to a Control condition in participants with CAI. * Specific Aim 3: Determine if a 6-week gait training with AudFB reduces episodes of ankle giving-way and reduces self-perceived severity of symptoms relative to a Control condition in participants with CAI.
Participants will:
* Complete 12 intervention sessions over a 6-week period of walking, ruck marching, and runninig. * Complete testing sessions before and after the intervention, then after 6 and 12-months following the intervention.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Walking
Other interventionWeeks 1-2, Sessions 1-4: The first condition will be walking with the speed self-selected based on "a comfortable pace to walk for exercise" as determined during the Baseline testing session. This speed will be held constant for the 10-minute walking portion prior to each condition but will be progressed for the remaining walking condition sessions (Sessions 2-4). The minimum speed will be limited to 1 mph.
Rucking
Other interventionWeeks 3-4, Session 5-8: The second condition will require participants to wear a standard rucksack equal to 20% of their body weight (minimum ruck weight: 15 pounds, maximum ruck weight: 45 pounds). The initial speed used during this condition will be self-selected based on "a comfortable pace to walk for exercise carrying this weight" as determined during the Baseline testing session.
Running
Other interventionWeeks 5-6, Sessions 9-12: The final condition is running. The self-selected running pace will be chosen as a pace that the participant can "sustain for a leisure run for 20 minutes," as determined at the Baseline testing session. Participants will only run for the 15-minute condition period.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 3 interventions
Group B: auditory biofeedback (AudFB) gait trainingExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Change in lower extremity biomechanics - peak pressure
The assessment will consist of a 45-minute treadmill loading protocol with 15 minutes of each: walking, running, and ruck marching.
Time frame
baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention2
Change in lower extremity biomechanics - maximum force
The assessment will consist of a 45-minute treadmill loading protocol with 15 minutes of each: walking, running, and ruck marching.
Time frame
baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention3
Change in lower extremity biomechanics - pressure-time integral
The assessment will consist of a 45-minute treadmill loading protocol with 15 minutes of each: walking, running, and ruck marching.
Time frame
baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention4
Change in lower extremity biomechanics - force-time integral
The assessment will consist of a 45-minute treadmill loading protocol with 15 minutes of each: walking, running, and ruck marching.
Time frame
baseline, immediately following the intervention, 6 months post intervention, and 12 months post interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Danielle Torp
Lead sponsor
University of Kentucky
Sponsor institution
Source ClinicalTrials.gov