Optimizing Gait Biomechanics for Posttraumatic Osteoarthritis Prevention

NCT05007366 | Completed

• 1 other identifier: 21-1489a
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to report the feasibility and determine the initial effects of 18 sessions of real-time gait biofeedback delivered over a 6-week period on retention and transfer of normalized gait biomechanics and improvements in indicators of early post-traumatic osteoarthritis development in those with an anterior cruciate ligament reconstruction (ACLR) at 6 and 8-week posttests.

Conditions

Anterior Cruciate Ligament Injuries; Post-traumatic Osteoarthritis; Knee Osteoarthritis; Knee Injuries; Cartilage, Articular; Gait

Keywords

Biofeedback

Outcome Measures

Primary Outcomes (6)

• Number of participants recruited using different recruitment modes

  The investigators will record the number of participants who were recruited, the frequency at which they were recruited, and where they were recruited from. Range 0-70. Higher number indicates more completion.

  Baseline (pre-intervention)

• The frequency of participant recruitment using different recruitment modes

  The investigators will record the number of participants who were recruited, the frequency at which they were recruited, and where they were recruited from. Range 0-70. Higher number indicates more completion.

  Baseline (pre-intervention)

• Percentage of participants who were successfully enrolled

  The investigators will record the number of participants who were successfully enrolled compared to the total number of participants screened. Range: 0-100. Higher percentage indicates more enrollment.

  Baseline (pre-intervention)

• Percentage of participants retained

  Investigators will record the percentage of patients retained at each monthly data capture timepoint.

  After week 4 and after week 8

• Reasons for refusal to enroll

  Investigators will record the reasons participants opt not to enroll in the study to determine whether there is a trend.

  Baseline (pre-intervention)

• Number of subjects who adhered to the intervention

  Percent of subjects who completed the sequence of training sessions and retention sessions. Range: 0-100. Higher percentage indicates more completion

  About 2 months

Secondary Outcomes (17)

• The change in vertical ground reaction force before and after intervention

  Up to 2 months

• The change in T1ρ MRI relaxation times before and after intervention

  Up to 2 months

• The change in T1ρ MRI relaxation times in the medial femoral condyle before and after intervention

  Up to 2 months

• The change in T1ρ MRI relaxation times in the lateral femoral condyle before and after intervention

  Up to 2 months

• The change in T1ρ MRI relaxation times in the medial tibial condyle before and after intervention

  Up to 2 months

Study Arms (2)

Real-time gait biofeedback (RTGBF)

ACTIVE COMPARATOR

The RTGBF regimen delivers biofeedback that cues a personalized target to normalize vertical ground reaction force (vGRF) of each limb.

Behavioral: Real-time gait biofeedback

Sham real-time gait biofeedback (Sham RTGBF)

SHAM COMPARATOR

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.

Behavioral: Sham real-time gait biofeedback

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 9th and 10th 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.

Real-time gait biofeedback (RTGBF)

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 9th and 10th 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)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Have completed all other formal physical therapy
• Are between the ages of 18 and 35
• Underwent an ACLR between 6 and 24 months prior to enrollment.
• Demonstrate underloading during gait (vGRF- impact peak \<1.09 x BW)
• Demonstrate clinically relevant-knee symptoms (KOOS-QOL \<72)
• Have undergone ACLR surgery

You may not qualify if:

• ACLR revision surgery
• A multiple ligament surgery
• A lower extremity fracture
• Knee osteoarthritis
• The participant has a BMI ≥ 36.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Arthritis Foundation: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Osteoarthritis, Knee; Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Brian Pietrosimone

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 16, 2021
• Study Start: August 5, 2021
• Primary Completion: December 2, 2022
• Study Completion: December 2, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 to 36 months
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

US (1)