NCT06529679

Brief Summary

The goal of this study is to determine short-term adaptations (aftereffects) in knee loading after a 20-minute split-belt treadmill training session in patients with ACL reconstruction. Our main question for this aim are:

  1. 1.Are training-mediated aftereffects in the knee joint moment greater for tied-belt walking or split-belt walking?
  2. 2.Are training-mediated aftereffects in the knee joint moment different between subjects who train early stance knee loading versus subjects who train mid-stance knee loading?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 29, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

July 26, 2024

Last Update Submit

April 28, 2026

Conditions

Keywords

BiomechanicsKnee loadingSplit-beltAsymmetric Walking

Outcome Measures

Primary Outcomes (1)

  • ACL Limb Sagittal Plane Knee Joint Moment

    Peak sagittal plane knee moment recorded from the ACL limb during walking gait

    Before (10min), during (20min), & after training (10min)

Other Outcomes (5)

  • Non-ACL Limb Sagittal Plane Knee Joint Moment

    Before (10min), during (20min), & after training (10min)

  • ACL Limb Vertical Ground Reaction Force

    Before (10min), during (20min), & after training (10min)

  • Non-ACL Limb Vertical Ground Reaction Force

    Before (10min), during (20min), & after training (10min)

  • +2 more other outcomes

Study Arms (2)

Early Stance Training

EXPERIMENTAL

This study arm will complete both a 20-minute split-belt \& tied-belt session. During the split-belt session, the ACL limb will walk at a faster speed (150-170% of 1.1 m/s) than the non-ACL limb (1.1 m/s). During the tied-belt session both limbs will walk at the same speed which will be set to match the faster speed of the ACL leg from the split-belt training day.

Behavioral: Split-belt TrainingBehavioral: Tied-Belt Training

Mid-Stance Training

EXPERIMENTAL

This study arm will complete both a 20-minute split-belt \& tied-belt session. During the split-belt session, the ACL limb will walk at a slower speed (30-50% of 1.1 m/s) than the non-ACL limb (1.1 m/s). During the tied-belt session both limbs will walk at the same speed which will be set to match the slower speed of the ACL leg from the split-belt training day.

Behavioral: Split-belt TrainingBehavioral: Tied-Belt Training

Interventions

Walking on a split-belt treadmill in which the speed of one belt will be different (move faster or slower) than the speed of the other belt.

Early Stance TrainingMid-Stance Training

Walking on a split-belt treadmill in which the speed of both belts is the same.

Early Stance TrainingMid-Stance Training

Eligibility Criteria

Age14 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • aged 14-45 years
  • suffered an acute, complete ACL rupture as confirmed by MRI and physical exam
  • have undergone ACL reconstruction w autograft within the past 10 months
  • willingness to participate in testing and follow-up as outlined in the protocol
  • English-speaking

You may not qualify if:

  • inability to provide written informed consent
  • female subjects who are pregnant or are planning to become pregnant (self-reported)
  • previous ACL injury
  • previous surgery to either knee
  • bony fracture accompanying ACL injury
  • patients who experienced a knee dislocation
  • patients who had their ACL reconstructed with an allograft
  • patients who underwent a multi-ligamentous and/or staged ACL reconstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Riann M Palmieri-Smith, PhD, ATC

    University of Michigan

    PRINCIPAL INVESTIGATOR
  • Chandramouli Krishnan, PT, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor School of Kinesiology

Study Record Dates

First Submitted

July 26, 2024

First Posted

July 31, 2024

Study Start

October 29, 2024

Primary Completion

February 25, 2026

Study Completion

February 25, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

De-identified data will be made publicly available via Deep Blue Data which is managed by the University of Michigan.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
We will strive to release data to the repository as rapidly as it is possible to analyze experiments and publish results. Data used in publications will be released at the time of publication.

Locations