Recruiting

Observational Study

Sponsor:

University of Connecticut

Code:

NCT05968729

Conditions

Anterior Cruciate Ligament Reconstruction

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Interventions

Active Comparator: 0.25 m/s asymmetric session first

Active Comparator: 0.50 m/s asymmetric session first

Study Details

Brief summary:

The purpose of this work is to conduct a comparative research-focused study to evaluate the effectiveness of how purposefully induced asymmetric walking protocols restore healthy, symmetric limb loading in individuals following post-anterior cruciate ligament reconstruction (ACLR) surgery. Additionally, computational modeling and machine learning to model knee loading in the clinic to determine the optimal asymmetric walking protocol to restore healthy gait in post-ACLR individuals.

Conditions

Anterior Cruciate Ligament Reconstruction

Study ID

NCT05968729

Start date

Sep 1, 2022

Status verified date

Jul, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Able to read and speak English
2. Age 18 - 30 years old
3. Undergone ACLR surgery at the UConn Musculoskeletal Institute
4. Must not have any concomitant surgeries or injuries
5. Must be cleared to return-to-sport by a physician after they have completed rehabilitation
6. Must be within 1 month of having been cleared for return-to-sport
7. Must present with between-limb gait differences in load rate greater than 10%

Exclusion Criteria:

1. Participants who have any recent inflammation, bleeding disorders, active bleeding, or infection within the lower limbs.
2. History of injuries to their patellar tendon
3. Cannot walk for extended periods of time
4. Cannot have had any back and/or lower extremity injury that affects their ability to move.
5. Cannot have difficulty or pain with walking, raising your arms, jogging, or jumping
6. Must not be allergic to tape.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: 0.25 m/s asymmetric session first

Participants will perform three 15-minute sessions of walking with a 0.25 m/s asymmetric walking gait speed difference where one limb is set at 1.0 m/s and the other limb is set at 1.25 m/s. Each of these sessions will be followed by 5-minute de-adaptation sessions where they will perform a symmetric walking trial at 1.0 m/s.

active comparator: 0.50 m/s asymmetric walking session first

Participants will perform three 15-minute sessions of walking with a 0.50 m/s asymmetric walking gait speed difference where one limb is set at 1.0 m/s and the other limb is set at 1.5 m/s. Each of these sessions will be followed by 5-minute de-adaptation sessions where they will perform a symmetric walking trial at 1.0 m/s.

Interventions

Active Comparator: 0.25 m/s asymmetric session first

Participants will first perform an asymmetric walking trial where the between-limb gait speed difference is 0.25 m/s on day one. On the second day, participants will perform an asymmetric walking trial where the between-limb gait speed difference is 0.50 m/s.

Active Comparator: 0.50 m/s asymmetric session first

Participants will first perform an asymmetric walking trial where the between-limb gait speed difference is 0.50 m/s on day one. On the second day, participants will perform an asymmetric walking trial where the between-limb gait speed difference is 0.25 m/s.

Primary outcome measure

  • Change in Loading Rate [ Time Frame: Screening, Baseline, and Post-Treatment (immediately following the completion of the second session) ]
  • Change in Peak Vertical Ground Reaction Force [ Time Frame: Baseline, Post-Treatment (immediately following the completion of the second session) ]
  • Change in Stride Time [ Time Frame: Baseline, Post-Treatment (immediately following the completion of the second session) ]
  • Change in Knee Loading [ Time Frame: Baseline, Post-Treatment (immediately following the completion of the second session) ]

Central Contacts and Locations

Central contacts

Kristin Morgan, PhD

860-486-8118kristin.2.morgan@uconn.edu

Noah Davidson, BS

860-486-8118noah.davidson@uconn.edu

Locations

University of Connecticut

Recruiting

Storrs, Connecticut, United States, 06269

Contacts

Kristin Morgan, PhD

860-486-8118kristin.2.morgan@uconn.edu

More Information

Sponsor

University of Connecticut

Last update posted

Aug 27, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Connecticut on 2025-08-27.