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Recruiting NCT05848622

Gait Rehabilitation to Treat FastOA

No phase Interventional Anterior Cruciate Ligament Injuries Post-traumatic Osteoarthritis Knee Osteoarthritis Osteo Arthritis Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Real-time gait biofeedback, Sham real-time gait biofeedback.
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament Injuries, Post-traumatic Osteoarthritis, Knee Osteoarthritis, Osteo Arthritis Knee. Basic parameters: 16 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Behavioral 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.
  • Behavioral 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.

Primary outcome measures

  • Mean Change from Baseline to Week 6 in Vertical Ground Reaction Force [Time frame: Baseline, Week 6]
  • Mean Change from Baseline to Month 6 in Vertical Ground Reaction Force [Time frame: Baseline, Month 6]
  • Mean Change from Baseline to Week 6 in Knee Joint Contact Forces [Time frame: Baseline, Week 6]
  • Mean Change from Baseline to Month 6 in Knee Joint Contact Forces [Time frame: Baseline, Month 6]
  • Mean Change from Baseline to Week 6 in Tibial Cartilage Strain [Time frame: Baseline, Week 6]
  • Mean Change from Baseline to Month 6 in Tibial Cartilage Strain [Time frame: Baseline, Month 6]
  • Mean Change from Baseline to Week 6 in the Knee Injury and Osteoarthritis Outcome Quality of Life Subscale Score [Time frame: Baseline, Week 6]
  • Mean Change from Baseline to Month 6 in the Knee Injury and Osteoarthritis Outcome Quality of Life Subscale Score [Time frame: Baseline, Month 6]
  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing Biomarker Chemokine (Monocyte Chemoattractant Protein-1 (MCP-1)). [Time frame: Baseline, Week 6]
  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Biomarker Chemokine (Monocyte Chemoattractant Protein-1 (MCP-1)). [Time frame: Baseline, Month 6]
Secondary outcome measures (3)
  • Change in the International Knee Documentation Committee Subjective Knee Evaluation Form Score [Time frame: Up to 6 months]
  • Change in the Tegner Activity Scale Score [Time frame: Up to 6 months]
  • Change in the Anterior Cruciate Ligament Return to Sport After Injury Scale Score [Time frame: Up to 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of North Carolina at Chapel Hill — Chapel Hill

Identifiers

NCT: NCT05848622 · 21-1489b

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗