Split-Belt Training for ACL Reconstruction

(Mi-SPA Trial)

Overseen By Riann M Palmieri-Smith, PhD, ATC

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Previous ACL injury, Knee surgery, others

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

9 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special treadmill training program for individuals who have undergone ACL (a knee ligament) reconstruction. Researchers aim to determine if walking on a split-belt treadmill, where each leg moves at a different speed, alters how the knee manages pressure. Participants are divided into two groups: one focuses on early stance and the other on midstance during walking, along with a placebo group receiving placebo split-belt training. Ideal candidates for this trial have had a complete ACL tear confirmed by MRI, have undergone surgery to repair it with an autograft (using their own tissue) within the last 10 months, and are willing to participate in follow-ups. As an unphased trial, this study offers participants the chance to contribute to innovative rehabilitation research that could enhance recovery for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this split-belt training is safe for ACL reconstruction?

Research shows that both early and mid-stance split-belt treadmill training programs have been tested for safety in people recovering from ACL surgery. Previous studies found these training methods generally easy for participants to handle. The research did not report any major negative effects, suggesting participants adjusted well to the new walking patterns.

In the studies, participants who underwent split-belt treadmill training learned and retained new walking patterns. This indicates that the body can adapt to this type of training without major problems. Although these studies didn't focus specifically on safety, the absence of reported negative effects suggests it is safe.

Since this study is in an early phase, it aims to collect initial data, so detailed safety information is not yet available. However, using split-belt training in similar situations has shown promising safety results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the split-belt training for ACL reconstruction because it offers a fresh approach to rehabilitation. Unlike traditional physical therapy, which often focuses on standard exercises and strengthening, this method uses a split-belt treadmill to create an asymmetrical walking pattern. This unique technique aims to retrain the brain and body to adapt to different walking speeds, potentially improving balance and movement efficiency post-surgery. The trial explores how varying the speed for the ACL leg can optimize recovery, offering a personalized and dynamic rehabilitation strategy that could enhance outcomes beyond what's currently possible with conventional therapies.

What evidence suggests that this trial's split-belt training interventions could be effective for ACL reconstruction?

Research has shown that split-belt treadmill training can improve knee function after ACL surgery. Studies have found that individuals who undergo ACL surgery can adapt and maintain improvements in their walking, resulting in more even step lengths. This balance is crucial for healing. In this trial, participants will be assigned to different training methods. The Early Stance Training arm focuses on reducing uneven knee pressure by having the ACL leg walk at 150-170% of 1.1 m/s, while the Mid-Stance Training arm has the ACL leg walk at 30-50% of 1.1 m/s. Both early and mid-stance training methods aim to enhance knee movement, though the benefits of each may vary. This approach offers hope for a more balanced and effective recovery. ^{4 5 6 7 8}

Who Is on the Research Team?

Chandramouli Krishnan, PT, PhD

Principal Investigator

University of Michigan

Riann M Palmieri-Smith, PhD, ATC

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals aged 14-45 who have had ACL reconstruction with autograft in the last 10 months. Participants must be willing to follow the study's procedures, speak English, and have confirmed acute complete ACL rupture by MRI and physical exam.

Inclusion Criteria

I speak English.

I am between 14 and 45 years old.

I am willing to follow the study's testing and follow-up schedule.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-week split-belt treadmill training program, with different protocols for early stance, mid-stance, and placebo groups

6 weeks

2 visits per week (in-person)

Follow-up

Participants are monitored for changes in knee biomechanics and other outcomes after the training period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Split-Belt Training
• Split-Belt Training

Trial Overview The study tests a split-belt treadmill training program designed to improve knee loading after ACL reconstruction. Nine subjects will be randomly assigned to two active training groups or a placebo group, comparing early stance versus midstance loading over six weeks.

How Is the Trial Designed?

Group I: Mid-Stance Training Experimental Treatment 1 Intervention

This study arm will complete 6-weeks of a split-belt treadmill training program. The program will require participants to walk on a split-belt treadmill 2 times a week for 20 minutes with the ACL leg walking at 30-50% of 1.1 m/s and the Non-ACL leg walking at 1.1 m/s.

Group II: Early Stance Training Experimental Treatment 1 Intervention

This study arm will complete 6-weeks of a split-belt treadmill training program. The program will require participants to walk on a split-belt treadmill 2 times a week for 20 minutes with the ACL leg walking at 150-170% of 1.1 m/s and the Non-ACL leg walking at 1.1 m/s.

Group III: Placebo Split-Belt Training Placebo Group 1 Intervention

This study arm will complete 6-weeks of a split-belt treadmill training program. The program will require participants to walk on a split-belt treadmill 2 times a week for 20 minutes with the ACL leg walking at a speed that is 10% different from 1.1 m/s and the Non-ACL leg walking at 1.1 m/s.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

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

Collaborator

Trials

508

Recruited

1,090,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0268003324000883

Individuals early after anterior cruciate ligament ... Results suggested individuals after anterior cruciate ligament reconstruction were able to adapt and retain step length symmetry changes as well as controls.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38669917/

Individuals early after anterior cruciate ligament reconstruction ... Findings: Results suggested individuals after anterior cruciate ligament reconstruction were able to adapt and retain step length symmetry changes as well as ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/03635465251365035?int.sj-full-text.similar-articles.9

The Effect of Decoupling Speed on Knee Biomechanics ... Split-belt treadmill training could be a viable intervention to target the loading asymmetry that is prevalent in persons post-ACLR. Anterior ...

4. withpower.com withpower.com/trial/phase-anterior-cruciate-ligament-injuries-8-2024-4795e

Split-belt Treadmill Training for ACL Injury (Mi-SPA Trial) The study tests how effective two types of treadmill training, tied-belt and split-belt, are at improving knee joint loading after ACL reconstruction.

5. clinicaltrial.be clinicaltrial.be/en/details/459329?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Michigan Split-belt Treadmill Training Program to Improve... Walking on a split-belt treadmill in which the belt under the ACL leg will move at a speed that is minimally slower than the other belt.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06529692

Michigan Split-belt Treadmill Training Program to Improve ... This study arm will complete 6-weeks of a split-belt treadmill training program. The program will require participants to walk on a split-belt treadmill 2 times ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11312549/

Individuals Early after ACL Reconstruction Show Intact Motor ... Individuals after anterior cruciate ligament reconstruction can learn a new gait pattern using sensorimotor adaptation, retain, and partially transfer the ...

8. trialx.com trialx.com/clinical-trials/listings/322839/michigan-split-belt-treadmill-training-program-to-improve-long-term-knee-biomechanics-after-acl-reconstruction/

Michigan Split-belt Treadmill Training Program to Improve ... Overview. The goal of this study is to gather pilot data to help inform a future clinical trial. As such, the investigators will employ a ...