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NCT Number: NCT05968729

Assessment of Gait Adaptation Due to an Asymmetric Walking Protocol

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut

Storrs, Connecticut, 06269, United States

Location status: Recruiting

Location contact

Kristin Morgan, PhD

CONTACT

[email protected]

860-486-8118

About this study

This is an intervention study in which participants will be randomized as to the order in which each of the two sessions are completed. Forty post-ACLR will who present with between-limb gait differences will perform two asymmetric walking sessions where they will walk with between-limb gait speed differences of 0.25 m/s and 0.50 m/s at three 15-minute intervals to evaluate the restoration of healthy gait. Post-ACLR participants will perform an asymmetric walking intervention protocol session on two different days. On one day they will perform the protocol with a 0.25 m/s between-limb difference and on a separate day they will perform the protocol with a 0.50 m/s between limb difference. For the 0.25 m/s condition, one limb will be set to 1.0 m/s and the other 1.25 m/s (i.e., 1.0 m/s - 1.25 m/s). Similarly, for the 0.50 m/s condition, one limb will be set to 1.0 m/s and the other 1.50 m/s (i.e., 1.0 m/s - 1.50 m/s). Each participant will perform both the 0.25 m/s and 0.50 m/s protocols on separate days, and we will randomize who performs which protocol first or second. At least 3 weeks must pass between the two one-day sessions. Patient-specific simulations will be generated in OpenSim for each of the 40 post-ACLR individuals to assess differences in knee joint loading. Together with machine learning, these models will help evaluate the effectiveness of the asymmetric walking protocol in reducing detrimental knee loading. The study team hypothesizes that the 0.50 m/s perturbation will produce a larger reduction in between-limb asymmetry than the 0.25 m/s perturbation and reduce detrimental knee loading.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Active Comparator: 0.25 m/s asymmetric session first

Other

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

Other

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 outcomes

  1. Change in Loading Rate

    Time frame: Screening, Baseline, and Post-Treatment (immediately following the completion of the second session)

    The rate at which the force is generated (Body Weight/sec). A decrease in loading rate would suggest that the participants adopted improved motor control while an increase would reflect impaired of motor control.

  2. Change in Peak Vertical Ground Reaction Force

    Time frame: Baseline, Post-Treatment (immediately following the completion of the second session)

    The largest force (newtons) produced during stance. An increase in force would that the participants are not properly engaging their muscles to control their movement.

  3. Change in Stride Time

    Time frame: Baseline, Post-Treatment (immediately following the completion of the second session)

    The time (seconds) measure from initial contact on the foot to the next initial contact on the same foot. A reduction in stride time would indicate that the participants are walking faster and more comfortable applying force to their limb during walking. An increase in walking speed, suggests that the participants are uncomfortable applying force to their limb.

  4. Change in Knee Loading

    Time frame: Baseline, Post-Treatment (immediately following the completion of the second session)

    The forces (newtons) experienced at the knee. An increase in knee loading would indicate that they participants are unable to properly support their knee during walking, while a reduction in knee loads would indicate the participants are engaging the appropriate muscles to support their knee during walking.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristin Morgan, PhD

CONTACT

[email protected]

860-486-8118

Noah Davidson, BS

CONTACT

[email protected]

860-486-8118

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 1, 2023
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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