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Real-time gait biofeedback (RTGBF) for Osteoarthritis

N/A
Waitlist Available
Led By Brian Pietrosimone
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have completed all other formal physical therapy
Underwent an ACLR between 6 and 24 months prior to enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 months
Awards & highlights

Study Summary

This trial found that real-time gait biofeedback can improve early indicators of post-traumatic osteoarthritis development in those who have had an ACLR.

Eligible Conditions
  • Posttraumatic Osteoarthritis
  • Anterior Cruciate Ligament Injury
  • Knee Injuries
  • Osteoarthritis
  • Articular Cartilage
  • Gait

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have finished all other prescribed physical therapy.
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You had a knee surgery called ACLR (anterior cruciate ligament reconstruction) between 6 and 24 months ago.
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You have had surgery to repair a torn ACL.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants recruited using different recruitment modes
Number of subjects who adhered to the intervention
Percentage of participants retained
+3 more
Secondary outcome measures
The change in T1ρ MRI relaxation times before and after intervention
The change in T1ρ MRI relaxation times in the lateral femoral condyle before and after intervention
The change in T1ρ MRI relaxation times in the lateral tibial condyle before and after intervention
+14 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Real-time gait biofeedback (RTGBF)Active Control1 Intervention
The RTGBF regimen delivers biofeedback that cues a personalized target to normalize vertical ground reaction force (vGRF) of each limb.
Group II: Sham real-time gait biofeedback (Sham RTGBF)Placebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,498 Previous Clinical Trials
4,176,188 Total Patients Enrolled
24 Trials studying Osteoarthritis
1,901 Patients Enrolled for Osteoarthritis
Arthritis FoundationOTHER
34 Previous Clinical Trials
46,127 Total Patients Enrolled
11 Trials studying Osteoarthritis
2,754 Patients Enrolled for Osteoarthritis
Brian PietrosimonePrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
31 Total Patients Enrolled
1 Trials studying Osteoarthritis
31 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I be eligible to participate in this clinical experiment?

"This research study is open to young adults aged 18-35 with gait issues, and aims to recruit a total of 70 participants."

Answered by AI

Are there still opportunities available to join this clinical research?

"Clinicaltrials.gov confirms that recruitment is ongoing for this particular medical trial, which was posted on August 5th 2021 and amended most recently on October 11th 2022."

Answered by AI

Is eligibility for this trial restricted to individuals aged 55 and younger?

"This medical trial has set 18 years old as the minimum age for enrollment and 35 years old as the maximum."

Answered by AI

How many individuals have thus far enrolled in this experiment?

"Affirmative. According to the information posted on clinical trials .gov, this medical trial which debuted on August 5th 2021 is presently seeking applicants. The study intends to recruit 70 participants from one site."

Answered by AI

What goals is this clinical trial intending to accomplish?

"The primary goal of this trial, the results of which will be measured after week 4 and 8 respectively, is to determine how many participants were recruited through different recruitment methods. Secondary objectives include measuring changes in Tegner Activity Scale score (a 11-point Likert scale used to quantify activity levels for individuals with ACL injury), peak knee flexion excursion (gait biomechanics collected using an eight camera three-dimensional motion analysis system while walking on a dual-belt, force-sensing treadmill) and joint tissues metabolism by assessing degenerative matrix metalloproteinase-3 (MMP-3) enzyme. Blood samples"

Answered by AI
~7 spots leftby Mar 2025