Assessment of Gait Adaptation Due to an Asymmetric Walking Protocol

U

University of Connecticut

Status

Enrolling

Conditions

Anterior Cruciate Ligament Reconstruction

Treatments

Other: Active Comparator: 0.25 m/s asymmetric session first
Other: Active Comparator: 0.50 m/s asymmetric session first

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05968729
K01AR079043 (U.S. NIH Grant/Contract)
H21-0176

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 30 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

40 participants in 2 patient groups

0.25 m/s asymmetric session first
Active Comparator group
Description:
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.
Treatment:
Other: Active Comparator: 0.25 m/s asymmetric session first
0.50 m/s asymmetric walking session first
Active Comparator group
Description:
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.
Treatment:
Other: Active Comparator: 0.50 m/s asymmetric session first

Trial contacts and locations

0

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Central trial contact

Noah Davidson, BS; Kristin Morgan, PhD

Data sourced from clinicaltrials.gov

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