Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2023-06-13
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Real-time gait biofeedback (RTGBF)
The RTGBF regimen delivers biofeedback that cues a personalized target to normalize vertical ground reaction force (vGRF) of each limb.
Real-time gait biofeedback
The RTGBF interventions will include eighteen step gait training sessions. The intervention will gradually increase to 3,000 steps at the 5th session with 100% feedback. During the remaining sessions, the intervention will include 3,000 steps, but the feedback will be gradually tapered off starting with the 11th session.
Sham real-time gait biofeedback (Sham RTGBF)
The Sham RTGBF regimen will receive biofeedback that cues their habitual step length determined during the accommodation period on the first session of treadmill walking.
Sham real-time gait biofeedback
The Sham RTGBF interventions will include eighteen step gait training sessions. The intervention will gradually increase to 3,000 steps at the 5th session with 100% feedback. During the remaining sessions, the intervention will include 3,000 steps, but the feedback will be gradually tapered off starting with the 11th session.
Interventions
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Real-time gait biofeedback
The RTGBF interventions will include eighteen step gait training sessions. The intervention will gradually increase to 3,000 steps at the 5th session with 100% feedback. During the remaining sessions, the intervention will include 3,000 steps, but the feedback will be gradually tapered off starting with the 11th session.
Sham real-time gait biofeedback
The Sham RTGBF interventions will include eighteen step gait training sessions. The intervention will gradually increase to 3,000 steps at the 5th session with 100% feedback. During the remaining sessions, the intervention will include 3,000 steps, but the feedback will be gradually tapered off starting with the 11th session.
Eligibility Criteria
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Inclusion Criteria
* Are between the ages of 16 and 35
* Underwent an anterior cruciate ligament reconstruction (ACLR) between 6 and 60 months prior to enrollment
* Demonstrate underloading during gait (vGRF- impact peak \<1.12 x BW)
Exclusion Criteria
* A lower extremity fracture (i.e., displaced tibial plateau fracture)
* Knee osteoarthritis
* The participant has a BMI ≥ 36.
16 Years
35 Years
ALL
No
Sponsors
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Arthritis Foundation
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Brian Pietrosimone, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Other Identifiers
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21-1489b
Identifier Type: -
Identifier Source: org_study_id
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