Split-belt Treadmill Training for ACL Injury

(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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different treadmill training methods affect knee loading after ACL surgery. The study compares two walking types: split-belt training, where each leg moves at a different speed, and tied-belt training, where both legs move at the same speed. Researchers aim to determine if these methods aid knee recovery by testing two approaches: training during early stance and training during mid-stance. Individuals who have undergone ACL reconstruction using their own tissue (autograft) within the last 10 months and are willing to participate in follow-up tests may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative rehabilitation methods that could enhance recovery for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that split-belt treadmill training is safe for ACL injury rehabilitation?

Research shows that split-belt treadmill training is generally safe for individuals recovering from ACL injuries. This training can improve walking patterns without causing major side effects. In healthy individuals, it has increased knee strength, indicating the body's ability to handle this exercise safely.

Tied-belt treadmill training, where both legs move at the same speed, is also used in recovery. It aims to enhance the knee's ability to handle weight after ACL surgery. Research suggests that individuals can safely adapt to new walking patterns with this training. No reports of serious side effects indicate it is well-tolerated.

As these are physical therapy methods and not medications, safety concerns differ but remain generally low. The training focuses on altering walking patterns to aid recovery after an ACL injury. Always consult a healthcare provider before starting any new rehabilitation program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about split-belt treadmill training for ACL injuries because it introduces a novel rehabilitation approach that focuses on differential limb speeds. Unlike standard physical therapy, which typically involves uniform gait training, this method uniquely uses varying speeds for the injured and non-injured limbs to improve coordination and recovery. The split-belt training aims to target and retrain the brain's motor control systems more effectively by simulating real-world walking challenges. This innovative approach may lead to faster and more comprehensive recovery for those suffering from ACL injuries.

What evidence suggests that this trial's treatments could be effective for ACL injury?

Research has shown that split-belt treadmill training, one of the methods studied in this trial, can significantly aid individuals who have undergone ACL (anterior cruciate ligament) surgery. This training involves walking on a treadmill where each leg moves at a different speed. Studies have found that this method increases the force applied to the knee over time in the leg on the slower belt. In contrast, tied-belt training, another method under study, involves both legs moving at the same speed and encourages new walking patterns. Both methods aim to enhance recovery after ACL surgery, helping patients regain improved knee function and balance. ^{1 2 3 5 6}

Who Is on the Research Team?

Chandramouli Krishnan, 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 English-speaking individuals aged 14-45 who have had an ACL reconstruction with autograft within the last 10 months due to a complete rupture confirmed by MRI and physical exam. Participants must be willing to follow the study's procedures.

Inclusion Criteria

I am between 14 and 45 years old.

I have a completely torn ACL confirmed by MRI and physical exam.

Willingness to participate in testing and follow-up as outlined in the protocol

Exclusion Criteria

Previous ACL injury

I am not pregnant and do not plan to become pregnant.

I have had surgery on one or both of my knees.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants undergo a 20-minute split-belt treadmill training session to assess knee loading adaptations

1 day

1 visit (in-person)

Follow-up

Participants are monitored for short-term adaptations in knee loading after training

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Split-belt Training
• Tied-Belt Training

Trial Overview The study tests how effective two types of treadmill training, tied-belt and split-belt, are at improving knee joint loading after ACL reconstruction. It looks at changes in knee biomechanics following a single 20-minute training session.

How Is the Trial Designed?

Group I: Mid-Stance Training Experimental Treatment 2 Interventions

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.

Group II: Early Stance Training Experimental Treatment 2 Interventions

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.

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+

Published Research Related to This Trial

In a study with 13 healthy participants, walking on a split-belt treadmill (where each belt moves at different speeds) did not change the frontal plane mechanics of the ankle, knee, and hip joints compared to normal walking.

However, as participants adapted to the split-belt walking, there was an increase in medio-lateral ground reaction forces and hip moment impulse on the faster limb, suggesting that this type of walking could be beneficial for therapy in individuals with gait issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Split-Belt Treadmill Walking Alters Lower Extremity Frontal Plane Mechanics. Roper, JA., Roemmich, RT., Tillman, MD., et al.[2018]

Walking on a split-belt treadmill (SBT) reveals distinct joint moment patterns in the legs, with the faster limb showing greater ground reaction forces and ankle moments, which could be beneficial for rehabilitation of unilateral gait deficits.

The study suggests that the different mechanics produced by each belt on the SBT can be strategically used to target specific locomotor impairments, as the fast and slow limbs exhibit unique moment impulses during walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower extremity sagittal joint moment production during split-belt treadmill walking. Roemmich, RT., Stegemöller, EL., Hass, CJ.[2021]

The split-belt treadmill is an effective tool for studying locomotor learning, allowing researchers to investigate both immediate and long-term gait adaptations in a controlled environment, which is crucial for optimizing motor rehabilitation strategies.

This paper outlines a specific protocol for using the split-belt treadmill, emphasizing the importance of controlling variables such as belt speeds and participant experience to ensure reliable results in understanding locomotor learning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a Split-belt Treadmill to Evaluate Generalization of Human Locomotor Adaptation. Vasudevan, EVL., Hamzey, RJ., Kirk, EM.[2019]

In a study involving 10 participants who completed 14 tied-belt and 39 split-belt walking trials, it was found that walking on a split-belt treadmill was only slightly more energy-consuming (0.13 ± 0.32 W/kg) than walking on tied belts at the average speed, suggesting that split-belt walking is not as energy-efficient as previously thought.

The research revealed that contrary to expectations, greater differences in belt speeds led to higher energy costs, indicating that while split-belt walking offers potential therapeutic benefits, it also increases the energetic demands on the walker, which should be considered in rehabilitation protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The energy cost of split-belt walking for a variety of belt speed combinations. Butterfield, JK., Collins, SH.[2022]

Asymmetric split-belt treadmill walking affects how much work is done at the hip and ankle joints, which is important for developing effective gait interventions.

Participants in the gradual training group showed increased hip work on the slower limb during training, suggesting that this area adapts to new walking patterns, but they reduced this work during retention tests, indicating a potential for learning and adaptation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Kinetic Strategies Adopted in Asymmetric Split-Belt Treadmill Walking. Hinkel-Lipsker, JW., Hahn, ME.[2018]

Citations

1. 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 ...

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

Individuals early after anterior cruciate ligament ... Split-belt treadmill walking: SAI adaptation, storage and retention effects ... Repeated split-belt treadmill training improves poststroke step length asymmetry.

3. reporter.nih.gov reporter.nih.gov/search/7S3Jh1Ya5USG9yxGiQ_jiA/project-details/11035197

Mi-SPA: Michigan Split-belt Adaptation Paradigm to Improve Knee ... Our own pilot data in ACL reconstructed individuals further supports the premise that split-belt treadmill training can profoundly increase loading in the ACL ...

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 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 ...

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... In healthy individuals, split-belt treadmill walking significantly increases (from baseline) knee moment impulses in the limb on the slow belt ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12125006/

Motor Learning of Knee Joint Kinematics in Patients Within the ... A split-belt treadmill is a tool that has been used to assess the ability to learn a new gait pattern, testing the underlying mechanism of ...