Neural Operant Conditioning for Stroke-Related Walking Difficulties

Overseen By Kristine Hansen, PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Must not be taking: Anti-spasticity, Seizure threshold

Disqualifiers: Neurological conditions, Musculoskeletal injury, Osteoarthritis, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called neural operant conditioning to assist individuals who have difficulty walking after a stroke. Researchers aim to determine if participants can learn to control their reflexes, potentially reducing muscle stiffness (spasticity) and improving walking skills. Participants will receive surface stimulation to their spine and will be asked to control their reflexes. The trial seeks individuals who had a stroke at least three months ago, can walk for at least five minutes, and experience mild to moderate walking challenges, particularly with knee bending. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery options for stroke survivors.

Will I have to stop taking my current medications?

If you are taking oral anti-spasticity medications, you will need to stop them to participate in this trial. The protocol does not specify other medications, so it's best to discuss your current medications with the study team.

What prior data suggests that this method is safe for stroke-related walking difficulties?

Research has shown that neural operant conditioning is still under investigation for safety and effectiveness. The trial is marked as "Not Applicable" for phase, indicating it may be in early stages or outside the usual clinical trial phases. This suggests limited information on tolerability and potential side effects.

Neural operant conditioning uses surface stimulation to enhance control over body reflexes, potentially reducing muscle tightness and improving walking. Detailed reports on side effects for this specific treatment are not yet available.

Studies of similar techniques often aim to improve muscle control and movement. While generally considered safe, details can vary based on treatment delivery. Prospective participants should discuss possible risks and benefits with the research team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Neural Operant Conditioning is unique because it focuses on retraining the brain to improve mobility, specifically targeting the neural pathways involved in walking. Unlike traditional rehabilitation methods for post-stroke Stiff-Knee gait, which often rely on physical exercises and are time-intensive, this approach uses real-time feedback to encourage the brain to adjust and optimize movement patterns. Researchers are excited about this treatment because it leverages neuroplasticity, potentially offering a more efficient and effective way to restore walking abilities in stroke survivors.

What evidence suggests that neural operant conditioning is effective for improving walking in stroke patients?

Research has shown that neural operant conditioning might help stroke patients walk better by reducing muscle tightness. Spasticity occurs when muscles remain tight, hindering movement. After a stroke, many people develop a Stiff-Knee gait (SKG), where the knee doesn't bend well during walking, making movement more difficult. Early studies suggest that neural operant conditioning can help patients learn to control their muscle reflexes better. This improved control could enhance knee movement and overall walking ability. Participants in this trial will undergo neural operant conditioning to evaluate its effectiveness in improving walking ability for those with post-stroke Stiff-Knee gait. ^{1 3 5 6 7}

Who Is on the Research Team?

James Sulzer, PhD

Principal Investigator

MetroHealth Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who had a stroke at least 3 months ago, can stand and walk for five minutes, and had independent mobility before their stroke. They should have reduced knee flexion when walking and be able to respond to nerve stimulation. People with severe cognitive issues, lower limb pain or injuries, certain neurological conditions other than stroke, uncontrolled seizures, or those pregnant cannot participate.

Inclusion Criteria

I have weakness on one side of my lower body.

Sign and date consent form

You were able to take care of yourself before getting sick.

Exclusion Criteria

Deficits in communication that interfere with reasonable study participation

I have severe difficulties in thinking and communicating.

I have seizures that are not controlled by medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surface stimulation to evoke spinal reflexes and attempt to self-regulate reflex excitability over multiple sessions

12 weeks

Multiple sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Assessments at 4, 12, and 24 weeks post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Neural Operant Conditioning

Trial Overview The study tests if operant conditioning with peripheral nerve stimulation can help stroke patients control spinal reflexes to reduce spasticity and improve walking. Participants' results will be compared with those of able-bodied individuals to assess the effectiveness of this technique.

How Is the Trial Designed?

Group I: Experimental: Post-stroke Stiff-Knee Gait Participants Experimental Treatment 1 Intervention

Individuals with post-stroke Stiff-Knee gait

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12187528/

Mechanisms of Post-Stroke Stiff Knee Gait: A Narrative ... Stroke results in significant motor function decline with only 50% of stroke survivors able to walk independently. While gait impairments are ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11863409/

Post-stroke Stiff-Knee gait: are there different types or ... Stiff-Knee gait (SKG) commonly occurs in individuals after stroke, loosely defined as reduced peak knee flexion angle during swing.

3. researchgate.net researchgate.net/publication/388070179_Mechanisms_of_Post-Stroke_Stiff_Knee_Gait_A_Narrative_Review

Mechanisms of Post-Stroke Stiff Knee Gait: A Narrative ... Stiff-Knee gait (SKG) is a dysfunction commonly observed post-stroke characterized by a decreased swing phase knee flexion angle. Importantly, SKG can impair ...

4. nature.com nature.com/articles/s41598-024-71083-1

Altered muscle synergy structure in patients with poststroke ... This study aimed to elucidate the muscle synergy characteristics during walking in patients with SKG after a stroke.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1052305720304535

Pedaling improves gait ability of hemiparetic patients with ... Pedaling increases knee flexion during the swing phase in hemiparetic patients with stiff-knee gait and improves gait ability.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10053067/

Stiff Knee Gait Disorders as Neuromechanical ... SKG can present as mechanical consequences between muscle spasticity, weakness, and their interactions with ground reactions during walking.

7. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01582-3

Post-stroke Stiff-Knee gait: are there different types or different ... Reduced knee flexion during gait following neurological injury such as stroke is very common, with estimated prevalence between 25 and 75% of ...