Assessment of Gait Adaptation Due to an Asymmetric Walking Protocol

NCT05968729 | Recruiting

• 2 other identifiers: H21-0176K01AR079043
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Change in Loading Rate

  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.

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

• Change in Peak Vertical Ground Reaction Force

  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.

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

• Change in Stride Time

  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.

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

• Change in Knee Loading

  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.

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

Study Arms (2)

0.25 m/s asymmetric session first

ACTIVE COMPARATOR

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.

Other: Active Comparator: 0.25 m/s asymmetric session first

0.50 m/s asymmetric walking session first

ACTIVE COMPARATOR

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.

Other: Active Comparator: 0.50 m/s asymmetric session first

Interventions

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.

0.25 m/s asymmetric session first

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.

0.50 m/s asymmetric walking session first

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Connecticut: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

RECRUITING

Study Officials

• Kristin Morgan, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Morgan, PhD

CONTACT

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

Noah Davidson, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 1, 2023
• Study Start: September 1, 2022
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)