Walking Adjustments for Stroke Recovery

Overseen By Natalia Sanchez, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Chapman University

Disqualifiers: Neurological disorders, Orthopedic conditions, Hypertension, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help stroke survivors improve their walking by examining how different techniques affect muscle control. Researchers will compare the effects of changing walking patterns with specific feedback (known as Voluntary Adjustments During Walking) to natural adjustments when walking conditions change. The goal is to restore muscle movement to a more normal state, enhancing walking ability. Individuals who had a stroke more than six months ago, can walk on a treadmill for two minutes, and can walk independently or with a cane are suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new rehabilitation techniques for stroke survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have uncontrolled hypertension, you may not be eligible to participate.

What prior data suggests that these walking adjustments are safe for stroke recovery?

Research has shown that practicing walking, known as gait training, is generally safe for people recovering from a stroke. One study found that a specific type of gait training called STAT was both feasible and safe for stroke survivors. This training improved walking without causing major harm.

Another review highlighted that many common gait training methods, such as muscle strengthening and treadmill use, are well-tolerated. These methods aim to enhance walking ability and are usually safe to try.

For those considering joining a trial involving voluntary changes while walking, evidence suggests it is a safe approach. The goal is to improve walking patterns after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Walking Adjustments for Stroke Recovery trial because it explores how voluntary adjustments during walking can improve muscle control after a stroke. Unlike traditional therapies that focus on passive exercises or assisted movements, this method encourages active participation from stroke survivors, potentially leading to more significant improvements in motor function. By comparing stroke participants' muscle control with neurotypical individuals, the trial aims to uncover specific changes caused by both stroke and the intervention, which could offer new insights into personalized recovery strategies.

What evidence suggests that voluntary adjustments during walking might be an effective treatment for stroke recovery?

This trial will compare muscle control in stroke participants with neurotypical participants during various walking modifications. Research has shown that voluntary changes in walking can improve patterns in stroke survivors. Studies have found that when stroke patients focus on adjusting their walking, their brains can better control movement, leading to improved recovery. For instance, technology-assisted walking practice significantly increased walking speed and stride length in stroke survivors. These voluntary walking exercises encourage the brain to form new connections, which is crucial for recovery. Overall, practicing these walking changes can lead to meaningful improvements in walking ability after a stroke. ^{1 6 7 8}

Are You a Good Fit for This Trial?

This trial is for stroke survivors with chronic hemiparesis who can walk on a treadmill for 2 minutes and over ground independently or with a cane. They must not have used a split-belt treadmill before, have no other neurological disorders or orthopedic conditions affecting their walk, and must have normal vision. Neurotypical adults without walking impairments, neurological disorders, severe head trauma in the last two years, or prior split-belt treadmill experience can also participate.

Inclusion Criteria

Adults with regular or corrected vision.

For stroke survivors: The ability for them or a guardian to provide informed consent

You have normal vision or wear glasses to correct your vision.

Exclusion Criteria

I do not have any brain or nerve conditions that affect my walking.

I have high blood pressure that isn't well-managed.

I have a condition that makes it hard for me to walk since my stroke.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo walking modifications using biofeedback and split-belt adaptation to assess muscle activation patterns and co-contraction

2 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Voluntary Adjustments During Walking

Trial Overview The study tests how stroke survivors adjust their walking patterns using biofeedback (explicit adjustments) versus adapting naturally to changes like those introduced by a split belt treadmill (implicit adjustments). It aims to understand muscle activation differences between these methods to improve post-stroke walking rehabilitation.

How Is the Trial Designed?

Group I: Stroke participants Experimental Treatment 2 Interventions

Researchers will assess muscle control in participants post-stroke during different types of walking modifications

Group II: Neurotypical participants Active Control 2 Interventions

Researchers will compare muscle control to neurotypical participants during the same types of walking modifications to assess stroke-induced changes in muscle control vs. intervention-induced changes in muscle control

Who Is Running the Clinical Trial?

Chapman University

Lead Sponsor

Trials

10

Recruited

920+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

The LEAPS trial aims to assess the effectiveness of specialized locomotor training programs (LTP) versus a home-based exercise program (HEP) in improving walking ability in 400 adults with moderate to severe walking limitations post-stroke, with outcomes measured at one year.

The trial will evaluate whether the timing of LTP delivery (2 or 6 months post-stroke) and the severity of initial impairment affect gait speed recovery, with a goal to detect a 20% difference in recovery rates and a 0.1 m/s difference in gait speed between the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. Duncan, PW., Sullivan, KJ., Behrman, AL., et al.[2023]

Walking on a split-belt treadmill (SBT) can help adults with chronic stroke adapt their gait patterns, with 156 patients studied across six selected trials.

Using dual motor tasks, like changing the slope or speed of the treadmill, enhances the retention of new motor patterns learned during therapy, while varying exercise intensity or speed disturbances does not significantly impact locomotor adaptation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Locomotor adaptation on a split-belt treadmill in adults with stroke: a systematic review. Fragoso-Espinosa, P., Alguacil-Diego, IM., Molina-Rueda, F.[2023]

Gait training using end-effector apparatus significantly improves gait velocity in post-stroke patients, with a mean difference of 0.16 m/s, based on a systematic review of 95 trials involving 4458 participants.

Both end-effector gait training and treadmill training with body weight support significantly enhance maximum walking distance, with improvements of 47 m and 38 m respectively, indicating their effectiveness in rehabilitation after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Improvement of Walking Ability Following Stroke. Mehrholz, J., Pohl, M., Kugler, J., et al.[2019]

The TWIST prediction tool, developed from a study of 93 stroke patients, accurately predicts the likelihood of regaining independent walking within 26 weeks post-stroke, achieving at least 83% accuracy across various time points.

Key predictors for the TWIST tool include age under 80, knee extension strength, and balance test scores, which can help clinicians make informed rehabilitation and discharge planning decisions for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The TWIST Tool Predicts When Patients Will Recover Independent Walking After Stroke: An Observational Study. Smith, MC., Barber, AP., Scrivener, BJ., et al.[2022]

The Interactive Walkway, which uses Kinect v2 sensors to assess walking adaptability, has shown good known-groups validity in distinguishing between stroke patients and healthy controls, indicating its effectiveness as a new assessment tool.

Walking adaptability outcomes from the Interactive Walkway complement traditional clinical tests and gait parameters, suggesting it could enhance individualized rehabilitation strategies for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing walking adaptability in stroke patients. Geerse, DJ., Roerdink, M., Marinus, J., et al.[2021]

In a study of 30 participants with chronic stroke, fallers exhibited a reduced balance tolerance limit (BTL) and more medial first steps during lateral waist-pull perturbations compared to nonfallers, indicating impaired balance recovery mechanisms.

Fallers also showed longer initiation times and reduced step length and clearance, particularly with their nonparetic leg, suggesting that targeted training on perturbation-induced stepping could be beneficial for fall prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lateral Perturbation-Induced and Voluntary Stepping in Fallers and Nonfallers After Stroke. Gray, VL., Fujimoto, M., Rogers, MW.[2023]

Gait training assisted by an endpoint robot led to significant improvements in walking speed and stride characteristics among six chronic stroke survivors, indicating enhanced mobility.

The training also improved balance during both standing and walking, and reduced reliance on compensatory strategies from the non-affected side, suggesting a more effective rehabilitation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional evaluation of robot end-point assisted gait re-education in chronic stroke survivors. De Luca, A., Lentino, C., Vernetti, H., et al.[2016]

Gait biofeedback shows promise in improving walking patterns for post-stroke individuals, but current studies are inconsistent in methodology, highlighting the need for larger, more uniform trials to better understand its effectiveness.

Wearable sensor technologies could enhance gait biofeedback applications, making it more accessible for telehealth and home rehabilitation, which may improve the quality of rehabilitation while reducing costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback for Post-stroke Gait Retraining: A Review of Current Evidence and Future Research Directions in the Context of Emerging Technologies. Spencer, J., Wolf, SL., Kesar, TM.[2021]

A study involving 30 acute post-stroke patients showed that early, intense supplemental gait training, whether through Lokomat® or conventional methods, was feasible and well-tolerated, leading to significant functional improvements.

Patients receiving Lokomat® training completed fewer sessions than those in conventional gait training but showed a trend towards greater efficiency in gait retraining, suggesting it may provide a more optimal therapy 'dose' despite the lower number of sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of supplemental gait training by robotic and conventional means in acute stroke rehabilitation. Talaty, M., Esquenazi, A.[2023]

In a study involving 22 individuals with chronic stroke, it was found that split-belt treadmill walking improved symmetry in double-limb support duration, indicating effective adaptation to this perturbation method.

Unilaterally applied resistance during walking led to reduced variability in swing phase duration, suggesting that different perturbation methods can influence the motor adaptation process in stroke patients, allowing them to learn to adjust to various walking challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unilaterally Applied Resistance to Swing Leg Shows a Different Adaptation Pattern Compared to Split-Belt Treadmill in Patients with Stroke. Mizrachi, N., Bar-Haim, S., Treger, I., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3196659/

Gait training strategies to optimize walking ability in people ... This paper systematically reviews common gait training strategies (neurodevelopmental techniques, muscle strengthening, treadmill training, intensive mobility ...

2. withpower.com withpower.com/trial/phase-stroke-8-2023-76c61

Walking Adjustments for Stroke Recovery Gait training assisted by an endpoint robot led to significant improvements in walking speed and stride characteristics among six chronic stroke survivors, ...

3. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.122.038956

Current Evidence for Walking Recovery After Stroke, Future ... This narrative review explores the state of the science in walking recovery after stroke and potential for development.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0966636224005654

Neuromotor recovery of walking in post-stroke individuals ... The most effective rehabilitation approaches require post-stroke patients to engage in voluntary training to optimize recovery through neural reorganization ...

5. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.120.032041

Gait Rehabilitation After Stroke Of the individuals who survive, more than 80% have gait impairment that recovers with some extent in the first 2 months after stroke. Yet, ...

6. physio-pedia.com physio-pedia.com/Gait_Training_in_Stroke

Gait Training in Stroke Gait training with a person following a stroke is highly individualized. The below video shows an example of progressive intensive individualized gait training.

7. mdpi.com mdpi.com/2077-0383/13/5/1358

Current Trends in Gait Rehabilitation for Stroke Survivors This scoping review seeks to identify current trends in gait rehabilitation for stroke survivors. Methods: The review followed the methodological framework ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999302002174

Gait outcomes after acute stroke rehabilitation with ... This pilot study showed that STAT is a feasible and safe technique with which to perform gait training with individuals who survive strokes and undergo acute ...