Gait Rehabilitation to Treat FastOA

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT05848622
Status
Recruiting
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Conditions

  • Anterior Cruciate Ligament Injuries
  • Cartilage, Articular
  • Gait
  • Knee Injuries
  • Knee Osteoarthritis
  • Osteo Arthritis Knee
  • Post-traumatic Osteoarthritis

Eligibility Criteria

Sex
ALL
Age
16 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Real-time gait biofeedback — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

The purpose of this study is to determine the effects of real-time gait biofeedback delivered over a 6-week period on early markers of FastOA and conduct 6-week and 6-month follow-up assessments in anterior cruciate ligament reconstructed patients.

Key Dates

Start date
Jun 13, 2023
Status verified
Jun 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Active Comparator: 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.
  • Sham Comparator: 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.

Primary Outcome Measure

Mean Change from Baseline to Week 6 in Vertical Ground Reaction Force [ Time Frame: Baseline, Week 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27516-

Find similar trials in Chapel Hill, NC

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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