Asymmetric Walking Protocols for ACL Reconstruction

Overseen By Noah Davidson, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Connecticut

Disqualifiers: Inflammation, Bleeding disorders, Infection, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best walking technique to help individuals recovering from ACL (a knee ligament) surgery regain a normal walking pattern. Participants will try different walking speeds on a treadmill to observe how their legs adjust. Researchers will use computer models to determine the most effective method. The study will focus on the Asymmetric Walking Protocol, also known as the Gait Retraining Protocol or Asymmetric Gait Training. Individuals who have undergone ACL surgery, are cleared to return to sports, and notice a difference in how their legs bear weight may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance recovery techniques 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.

What prior data suggests that the Asymmetric Walking Protocol is safe for post-ACLR individuals?

Research shows that special walking exercises have been studied to assess their impact on weight balance between legs after ACL surgery. These studies found that this type of walking can help even out weight distribution between the legs in the short term. Importantly, no serious side effects emerged in these studies, suggesting that the exercises are generally safe and well-tolerated. However, anyone considering joining a trial should discuss potential risks with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Asymmetric Walking Protocols for ACL Reconstruction because they offer a novel approach to rehabilitation. Unlike traditional physical therapy methods that focus on symmetric gait training, this protocol uses asymmetric walking speeds to potentially enhance recovery. By setting one limb at a different speed than the other, it aims to improve muscle coordination and balance more effectively, which could lead to faster and more complete rehabilitation. This innovative method could provide a more tailored and dynamic recovery process, potentially improving outcomes for those recovering from ACL surgery.

What evidence suggests that the Asymmetric Walking Protocol is effective for restoring healthy gait in post-ACLR individuals?

This trial will compare two different asymmetric walking protocols for ACL reconstruction recovery. Research has shown that walking unevenly can help people regain balance after ACL surgery. One study found that changing the speed of each leg while walking helped patients quickly learn to balance weight on both legs, improving how evenly they could distribute their weight. Another study found that retraining walking patterns improved hip and knee movements, which is crucial after surgery. These findings suggest that walking unevenly might help patients recover a more natural walking pattern post-ACL surgery. Participants in this trial will first be assigned to either a 0.25 m/s or a 0.50 m/s asymmetric walking session to evaluate the effectiveness of these protocols. ^{1 4 5 6 7}

Who Is on the Research Team?

Kristin Morgan, PhD

Principal Investigator

University of Connecticut

Are You a Good Fit for This Trial?

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.

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

I was cleared to return to sports within the last month.

Exclusion Criteria

Must not be allergic to tape

I have had injuries to my patellar tendon.

I cannot walk for long periods.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Asymmetric Walking Protocol

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.

How Is the Trial Designed?

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+

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 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]

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10664454/

Effect of Purposely Induced Asymmetric Walking Perturbations ... Asymmetric walking successfully produced the short-term adaptation of interlimb loading rate symmetry in patients after ACLR and induced the temporary storage ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38021311/

Effect of Purposely Induced Asymmetric Walking ... Conclusion: Asymmetric walking successfully produced the short-term adaptation of interlimb loading rate symmetry in patients after ACLR and ...

3. nature.com nature.com/articles/s41598-018-30459-w

Effect of dual task on gait asymmetry in patients after ... Individuals who received anterior cruciate ligament (ACL) reconstruction surgeries demonstrated lower extremity movement asymmetries.

4. researchgate.net researchgate.net/publication/8577017_Gait_retraining_after_anterior_cruciate_ligament_reconstruction

Gait retraining after anterior cruciate ligament reconstruction Gait retraining with the FDHO model showed improvements in lower-extremity positions, hip and knee extensor angular impulse, and work parameters.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05968729

Assessment of Gait Adaptation Due to an Asymmetric ... The purpose of this work is to conduct a comparative research-focused study to evaluate the effectiveness of how purposefully induced asymmetric walking ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7872452/

Patients Walking Faster After Anterior Cruciate Ligament ... This data suggests that interventions that solely increase walking speed may accentuate gait symmetry in athletes early after ACLR. Gait-specific, unilateral, ...

7. ijspt.scholasticahq.com ijspt.scholasticahq.com/article/18710-patients-walking-faster-after-anterior-cruciate-ligament-reconstruction-have-more-gait-asymmetry

Patients Walking Faster After Anterior Cruciate Ligament ... This data suggests that interventions that solely increase walking speed may accentuate gait symmetry in athletes early after ACLR. Gait- ...