Michigan Split-belt Treadmill Training Program to Improve Acute Knee Biomechanics After ACL Reconstruction
Mi-SPA
Mi-SPA: Michigan Split-belt Adaptation Paradigm to Improve Knee Loading After Anterior Cruciate Ligament Reconstruction (Aim 2)
2 other identifiers
interventional
32
1 country
1
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.Are training-mediated aftereffects in the knee joint moment greater for tied-belt walking or split-belt walking?
- 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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
1 active site
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
CompletedFirst Posted
Study publicly available on registry
July 31, 2024
CompletedStudy Start
First participant enrolled
October 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2026
CompletedMay 5, 2026
April 1, 2026
1.3 years
July 26, 2024
April 28, 2026
Conditions
Keywords
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
EXPERIMENTALThis 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.
Mid-Stance Training
EXPERIMENTALThis 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.
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.
Walking on a split-belt treadmill in which the speed of both belts is the same.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Riann M Palmieri-Smith, PhD, ATC
University of Michigan
- PRINCIPAL INVESTIGATOR
Chandramouli Krishnan, PT, PhD
University of Michigan
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
- 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.
De-identified data will be made publicly available via Deep Blue Data which is managed by the University of Michigan.