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

35 Participants Needed

Trial Summary

What is the purpose of this trial?

People post-stroke retain the capacity to modify walking patterns explicitly using biofeedback and implicitly when encountering changes in the walking environment. This proposal will assess changes in muscle activation patterns associated with walking modifications driven explicitly vs. implicitly, to determine whether individuals generate different amounts of co-contraction during explicit vs. implicit walking modifications. Understanding how walking modifications driven explicitly vs. implicitly influence co-contraction will allow the investigators to identify approaches that can more effectively restore muscle activation toward pre-stroke patterns, promoting mechanism-based recovery of walking function.

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 data supports the effectiveness of the treatment Voluntary Adjustments During Walking, Gait Training, Walking Rehabilitation, Post-stroke Gait Therapy?

Research shows that gait training, including methods like robotic assistance and biofeedback, can improve walking speed, balance, and reduce compensatory movements in stroke survivors. These findings suggest that similar treatments focusing on voluntary adjustments during walking may also be effective in enhancing post-stroke gait recovery. ^{1 2 3 4 5}

Is walking rehabilitation safe for stroke recovery?

The studies reviewed do not report any specific safety concerns related to walking rehabilitation for stroke recovery, suggesting it is generally safe for humans. However, more research is needed to confirm these findings and ensure safety across different methods and technologies used in walking rehabilitation. ^{3 4 6 7 8}

How does the 'Walking Adjustments for Stroke Recovery' treatment differ from other stroke recovery treatments?

The 'Walking Adjustments for Stroke Recovery' treatment is unique because it focuses on adapting walking patterns through specific perturbation methods like split-belt treadmill walking and unilaterally applied resistance to the swing leg, which target different motor adaptation processes in the brain. This approach contrasts with traditional methods by emphasizing the learning process in the central nervous system and adapting to mechanical resistance, offering a novel way to improve walking ability post-stroke. ^{1 3 4 9 10}

Eligibility Criteria

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.

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

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

Functional evaluation of robot end-point assisted gait re-education in chronic stroke survivors. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of supplemental gait training by robotic and conventional means in acute stroke rehabilitation. [2023]

3. Switzerland 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. [2023]

4. Switzerland 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. [2021]

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

The TWIST Tool Predicts When Patients Will Recover Independent Walking After Stroke: An Observational Study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Assessing walking adaptability in stroke patients. [2021]

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

Lateral Perturbation-Induced and Voluntary Stepping in Fallers and Nonfallers After Stroke. [2023]

9. Spain pubmed.ncbi.nlm.nih.gov

Locomotor adaptation on a split-belt treadmill in adults with stroke: a systematic review. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

The Improvement of Walking Ability Following Stroke. [2019]