Gait rehabilitation using biofeedback for knee injuries
Gait Rehabilitation to Treat FastOA
This study is testing if real-time feedback on walking can help younger people who had knee surgery recover better and avoid early signs of osteoarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 16 Years to 35 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05848622 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of real-time gait biofeedback on early markers of fast osteoarthritis in patients who have undergone anterior cruciate ligament reconstruction. Participants will receive either active or sham biofeedback over a 6-week period, followed by assessments at 6 weeks and 6 months post-intervention. The focus is on understanding how gait modifications can influence recovery and prevent the onset of osteoarthritis. The study targets younger individuals who have completed their physical therapy and exhibit specific gait characteristics.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 to 35 who have had anterior cruciate ligament reconstruction within the last 6 months to 5 years and show specific gait patterns.
Not a fit: Patients with multiple ligament surgeries, significant knee osteoarthritis, or a high BMI may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and reduce the risk of developing osteoarthritis in young patients post knee surgery.
How similar studies have performed: While the specific approach of real-time gait biofeedback is relatively novel, similar interventions have shown promise in improving rehabilitation outcomes in related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have completed all other formal physical therapy * 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 multiple ligament surgery (i.e., PCL) * A lower extremity fracture (i.e., displaced tibial plateau fracture) * Knee osteoarthritis * The participant has a BMI ≥ 36.
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Brian Pietrosimone, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Natalia Favoreto, MS
- Email: favoreto@med.unc.edu
- Phone: 9199622025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.