Asymmetric Walking Protocols for ACL Reconstruction

Recruiting in Palo Alto (17 mi)

Overseen by Kristin Morgan, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Connecticut

Disqualifiers: Inflammation, Bleeding disorders, Infection, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Asymmetric Walking Protocol for ACL reconstruction?

Research shows that gait retraining and rehabilitation protocols can improve walking patterns and functional recovery after ACL reconstruction. Specifically, improvements in gait symmetry and movement range were observed during physiotherapy, indicating potential benefits of such treatments. ^{1 2 3 4 5}

Is the Asymmetric Walking Protocol safe for humans?

The research does not provide specific safety data for the Asymmetric Walking Protocol, but it highlights the importance of addressing movement asymmetries after ACL reconstruction to prevent potential negative outcomes. ^{3 4 6 7 8}

How does the Asymmetric Walking Protocol treatment differ from other treatments for ACL reconstruction?

The Asymmetric Walking Protocol is unique because it focuses on retraining walking patterns to address movement asymmetries after ACL reconstruction, which are common and can lead to further joint issues. Unlike traditional therapies that may emphasize symmetry, this protocol specifically targets and adjusts the asymmetrical gait patterns to improve overall function and prevent long-term complications. ^{1 3 4 5 9}

Research Team

Kristin Morgan, PhD

Principal Investigator

University of Connecticut

Eligibility Criteria

This trial is for individuals aged 18-30 who have undergone ACL reconstruction at the UConn Musculoskeletal Institute and are cleared to return to sport. They must show a significant difference in limb loading when walking, speak English, and not have other injuries or conditions that affect movement.

Inclusion Criteria

I have not had any recent surgeries or injuries.

Able to read and speak English

I walk with a noticeable difference in how I put weight on my legs.

Exclusion Criteria

I have had injuries to my patellar tendon.

Must not be allergic to tape

I cannot walk for long periods.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform two asymmetric walking sessions with between-limb gait speed differences of 0.25 m/s and 0.50 m/s, each on separate days with at least 3 weeks between sessions.

6 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in knee loading and gait adaptation immediately following the completion of the second session.

1 week

Treatment Details

Interventions

• Asymmetric Walking Protocol (Behavioural Intervention)

Trial Overview The study tests two different asymmetric walking speeds (0.25 m/s and 0.50 m/s) first on people after ACL surgery to see which better restores balanced limb loading. It uses computational models and machine learning to analyze knee loading.

Participant Groups

Group I: 0.25 m/s asymmetric session first Active Control 1 Intervention

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.

Group II: 0.50 m/s asymmetric walking session first Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Connecticut

Lead Sponsor

Trials

194

Recruited

162,000+

Lisa Dunkle

University of Connecticut

Chief Medical Officer since 2018

MD from Johns Hopkins University

Erika Smith

University of Connecticut

Chief Executive Officer since 2020

MBA from the University of Connecticut

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

Collaborator

Trials

508

Recruited

1,090,000+

Dr. Lindsey A. Criswell

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

Director since 2021

MD, MPH, DSc

Dr. Robert Colbert

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

Clinical Director since 2014

MD

Findings from Research

In a study of 97 males, including 53 post-ACL reconstruction patients, significant improvements in gait kinematics were observed from the 2nd to the 12th week of physiotherapy, with gait velocity increasing by over 0.97 m/s.

The relative length of the stance phase in the affected leg increased significantly from 36.1% to 62.7%, and the range of knee movement improved from 25.8 degrees to 63.7 degrees, indicating effective rehabilitation progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of gait kinematics and symmetry during the first two stages of physiotherapy after anterior cruciate ligament reconstruction. Winiarski, S., Czamara, A.[2016]

A study of 70 males after ACL reconstruction showed that following a structured rehabilitation protocol significantly improved thigh muscle circumference and functional recovery compared to those who did not follow the protocol.

Patients who adhered to the rehabilitation protocol had statistically significant better outcomes in muscle size and functional scores at 1, 3, 6, and 12 months post-surgery, indicating the importance of rehabilitation in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of rehabilitation protocol on functional recovery after anterior cruciate ligament reconstruction. Dragicevic-Cvjetkovic, D., Jandric, S., Bijeljac, S., et al.[2022]

A study involving 40 men who underwent ACL reconstruction found that neither standard strength and agility training nor additional perturbation training effectively restored gait symmetry 1 or 2 years post-surgery.

Despite some improvement in gait asymmetries over time, significant interlimb asymmetries persisted in both training groups, suggesting that further interventions may be needed to fully address these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Report of the Primary Outcomes for Gait Mechanics in Men of the ACL-SPORTS Trial: Secondary Prevention With and Without Perturbation Training Does Not Restore Gait Symmetry in Men 1 or 2 Years After ACL Reconstruction. Capin, JJ., Zarzycki, R., Arundale, A., et al.[2022]

Gait retraining using the force-driven harmonic oscillator (FDHO) model significantly improved lower-extremity kinematics and kinetics in patients with ACL reconstruction, while the preferred stride frequency (PSF) protocol showed no improvements.

The FDHO protocol led to better recovery in knee range of motion and hip extensor function over a 6-week training period, indicating its effectiveness in enhancing gait patterns post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait retraining after anterior cruciate ligament reconstruction. Decker, MJ., Torry, MR., Noonan, TJ., et al.[2022]

The authors argue that focusing solely on targeting asymmetry in rehabilitation after ACL reconstruction may not be sufficient to identify all deficits in recovery.

They suggest that a broader approach may be necessary to fully assess and address the rehabilitation needs of patients post-ACL surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACL rupture is a single leg injury but a double leg problem: too much focus on 'symmetry' alone and that's not enough! Benjaminse, A., Holden, S., Myer, GD.[2020]

Addressing abnormal movement patterns, particularly the kinetic component of lower extremity loading, is crucial for successful rehabilitation after ACL reconstruction, as it can impact athletic performance and recovery.

Asymmetrical loading in the lower extremities is common after ACL surgery and may lead to both short- and long-term negative outcomes, highlighting the need for clinicians to focus on this aspect during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asymmetrical lower extremity loading after ACL reconstruction: more than meets the eye. Chmielewski, TL.[2018]

In a study of 28 males who underwent ACL reconstruction, higher levels of kinesiophobia (fear of reinjury) were significantly associated with greater asymmetry in vertical ground reaction forces during gait, indicating that psychological factors can impact physical recovery.

The study also found that kinesiophobia correlated with asymmetrical muscle activity in key leg muscles during walking, suggesting that addressing these psychological concerns early in rehabilitation could help improve gait symmetry and reduce the risk of reinjury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between Kinesiophobia and Gait Asymmetry after ACL Reconstruction: Implications for Prevention of Reinjury. Tajdini, H., Letafatkar, A., Brewer, BW., et al.[2021]

In a study of 23 adolescent patients 6 months post-ACL reconstruction, wearing a knee brace significantly increased knee flexion on the surgical side, suggesting improved joint function during rehabilitation.

The knee brace also promoted more symmetrical loading across both limbs, which may help reduce the risk of secondary ACL tears by normalizing lower extremity mechanics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in landing mechanics in patients following anterior cruciate ligament reconstruction when wearing an extension constraint knee brace. Butler, RJ., Dai, B., Garrett, WE., et al.[2022]

In individuals who have undergone anterior cruciate ligament (ACL) reconstruction, faster walking speeds significantly increase ground reaction force (GRF) asymmetries compared to slower speeds, indicating a potential risk for further injury during rehabilitation.

The study involved 30 ACL-reconstructed individuals and 15 uninjured controls, suggesting that assessing both preferred and faster walking speeds can help identify biomechanical issues early in rehabilitation, before progressing to more demanding activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait asymmetries are exacerbated at faster walking speeds in individuals with acute anterior cruciate ligament reconstruction. Garcia, SA., Brown, SR., Koje, M., et al.[2023]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Evaluation of gait kinematics and symmetry during the first two stages of physiotherapy after anterior cruciate ligament reconstruction. [2016]

2. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

The effects of rehabilitation protocol on functional recovery after anterior cruciate ligament reconstruction. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Report of the Primary Outcomes for Gait Mechanics in Men of the ACL-SPORTS Trial: Secondary Prevention With and Without Perturbation Training Does Not Restore Gait Symmetry in Men 1 or 2 Years After ACL Reconstruction. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Gait retraining after anterior cruciate ligament reconstruction. [2022]

5. England pubmed.ncbi.nlm.nih.gov

ACL rupture is a single leg injury but a double leg problem: too much focus on 'symmetry' alone and that's not enough! [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Asymmetrical lower extremity loading after ACL reconstruction: more than meets the eye. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Association between Kinesiophobia and Gait Asymmetry after ACL Reconstruction: Implications for Prevention of Reinjury. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Changes in landing mechanics in patients following anterior cruciate ligament reconstruction when wearing an extension constraint knee brace. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Gait asymmetries are exacerbated at faster walking speeds in individuals with acute anterior cruciate ligament reconstruction. [2023]