Operant Conditioning for Foot Drop Post-Stroke

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Nevada, Las Vegas

Disqualifiers: Cerebellar stroke, other neurological diseases

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial helps stroke survivors with foot drop improve their muscle control. The study focuses on people who have ongoing muscle weakness in their legs after a stroke. By practicing specific movements and getting feedback, participants can learn to better control their muscles.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators.

What data supports the effectiveness of the treatment Operant conditioning for Foot Drop Post-Stroke?

Research shows that operant conditioning, which involves rewarding desired behaviors, has been effective in improving motor abilities and functional independence in stroke patients by overcoming learned nonuse (a condition where patients stop using an affected limb). Additionally, combining operant conditioning with physiotherapy has helped individuals with movement difficulties learn necessary skills, suggesting it could be beneficial for foot drop post-stroke. ^{1 2 3 4 5}

Is operant conditioning therapy safe for humans?

Operant conditioning therapy has been used safely in humans for various conditions, including stroke rehabilitation and spinal cord injuries, with no reported safety concerns in the studies reviewed. ^{1 2 3 6 7}

How is operant conditioning treatment different from other treatments for foot drop post-stroke?

Operant conditioning treatment is unique because it uses a learning-based approach to gradually change spinal reflexes, helping to restore movement skills by encouraging the nervous system to adapt and reorganize itself, unlike traditional therapies that may focus more on physical exercises or medication. ^{1 3 8 9 10}

Research Team

Eligibility Criteria

This trial is for adults over 18 who had a stroke at least 6 months ago, resulting in hemiparesis and foot drop. Participants must be able to see computer icons from 4 feet away, follow verbal instructions, walk with or without help despite gait issues due to weak tibialis anterior muscle.

Inclusion Criteria

I had a stroke 6 months ago that caused weakness on one side of my body.

I am at least 18 years old.

I can walk, but I have difficulty lifting the front part of my foot.

Exclusion Criteria

I have no neurological issues affecting my legs/walking besides stroke.

I have had a stroke in the cerebellum.

I have no ear or balance issues not caused by a stroke.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants complete 6 baseline sessions to establish initial reflex pathway measurements

1-2 weeks

6 visits (in-person)

Treatment

Participants undergo 30 up conditioning sessions to modify reflex pathways in the paretic leg

3 months

30 visits (in-person)

Follow-up

Participants are monitored for changes in reflex pathways and walking ability post-treatment

4 weeks

Treatment Details

Interventions

• Operant conditioning (Behavioral Intervention)

Trial Overview The study tests reflex training using operant conditioning on the ankle plantarflexors of individuals with post-stroke hemiparesis. It involves attending 40 sessions over approximately four months to improve walking ability and manage foot drop.

Participant Groups

Group I: Reciprocal inhibition up conditioning Experimental Treatment 1 Intervention

Each participant completes 6 baseline sessions and 30 up conditioning sessions. In the 30 conditioning sessions, the magnitude of reciprocal inhibition in the paretic leg of participants post-stroke will be up conditioned.

Who Is Running the Clinical Trial?

University of Nevada, Las Vegas

Lead Sponsor

Trials

81

Recruited

14,700+

Dr. Albert Bourla

University of Nevada, Las Vegas

Chief Executive Officer since 2019

PhD in Molecular Biology, Harvard Medical School

Dr. Patrizia Cavazzoni

University of Nevada, Las Vegas

Chief Medical Officer

McGill University, MD

Findings from Research

The multidisciplinary intervention using operant conditioning significantly improved the rehabilitation outcomes for a 53-year-old woman post-cerebrovascular accident, leading to increased compliance in activities of daily living (ADLs) and improved motivation for therapy.

The program effectively utilized a reward system, where positive behaviors were reinforced with privileges and tokens, resulting in a dramatic increase in appropriate behaviors immediately after implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Operant conditioning for management of a noncompliant rehabilitation case after stroke. Jain, S.[2023]

A new rehabilitation method based on operant conditioning has shown promise in overcoming 'learned nonuse' of affected limbs in chronic stroke patients, suggesting that some motor disability is due to learned suppression of movement rather than just physical impairment.

In a 2-week study involving stroke patients, restricting the unaffected limb while training the affected one led to significant improvements in motor ability and functional independence, with additional benefits observed when verbal feedback was used during training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An operant approach to rehabilitation medicine: overcoming learned nonuse by shaping. Taub, E., Crago, JE., Burgio, LD., et al.[2022]

Operant conditioning protocols can effectively modify spinal reflexes, which are fundamental behaviors, providing valuable insights into the mechanisms of learning.

These protocols can also promote neural plasticity, potentially aiding in the recovery of motor skills like walking in individuals with spinal cord injuries or related disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The simplest motor skill: mechanisms and applications of reflex operant conditioning. Thompson, AK., Wolpaw, JR.[2021]

In a study involving 17 hemiplegic stroke patients, the addition of an inhibitor bar to an ankle-foot orthosis (AFO) significantly improved walking ability in patients with tonic toe flexion reflex (TTFR), increasing walking speed by 13.8% over 2 weeks.

The control group, which did not have TTFR, showed no significant changes, highlighting the targeted efficacy of the inhibitor bar for those specifically affected by this reflex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An ankle-foot orthosis with inhibitor bar: effect on hemiplegic gait. Iwata, M., Kondo, I., Sato, Y., et al.[2019]

A severely disabled child with hemiplegia showed progress in learning to walk through a combination of operant conditioning and physiotherapy, indicating that behavior modification can be effective in rehabilitation.

The study highlights the usefulness of operant conditioning not only as a teaching technique but also as a method for objective data collection and evaluation in therapy programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining the techniques of physiotherapy and behaviour modification. Zeidler, LJ., Zimmer-Hart, CL.[2014]

The study successfully used an operant conditioning approach to train a patient with anoxic encephalopathy, leading to significant improvements in bowel and bladder continence, daily activity participation, and reduced aggression after two years of previous unsuccessful rehabilitation.

After four months of targeted training, the patient showed notable progress in all targeted behaviors, demonstrating the potential efficacy of operant conditioning in enhancing functional outcomes in similar patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anoxic encephalopathy: a neurobehavioural study in rehabilitation. Goldberg, KB., Ellis, DW.[2019]

Operant-conditioning protocols that reward specific electromyographic responses can effectively modify spinal reflex pathways, leading to changes in reflex activity and associated behaviors in both animals and humans.

In individuals with partial spinal cord injuries, these conditioning techniques can enhance locomotion and promote widespread beneficial plasticity in the nervous system, suggesting a promising therapeutic approach for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted neuroplasticity for rehabilitation. Thompson, AK., Wolpaw, JR.[2018]

In a case study of a patient with aggressive behavior linked to avoidance of rehabilitation, traditional operant conditioning methods like differential reinforcement of incompatible behavior (DRI) and low rates of responding (DRL) were ineffective.

Conversely, using situational time out (STO) combined with sustained verbal prompting significantly reduced aggression, highlighting the importance of tailoring interventions to the specific functions of challenging behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active versus passive management of post-acquired brain injury challenging behaviour: a case study analysis of multiple operant procedures in the treatment of challenging behaviour maintained by negative reinforcement. Stewart, I., Alderman, N.[2019]

Operant conditioning of spinal reflexes has evolved over 35 years from basic science to a promising rehabilitation therapy for spinal cord injuries, showing significant potential for enhancing nervous system plasticity.

Initial studies in both animal models and humans indicate that reflex conditioning can lead to exciting therapeutic outcomes, highlighting the importance of basic research in informing clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Operant conditioning of spinal reflexes: from basic science to clinical therapy. Thompson, AK., Wolpaw, JR.[2022]

A 24-session conditioning protocol significantly altered the H-reflex recruitment curves in subjects, indicating that operant conditioning can modify reflex responses across various stimulus strengths, not just at a specific threshold.

Both up-conditioning (HRup) and down-conditioning (HRdown) resulted in overall shifts in the H-reflex response, suggesting that these conditioning methods can broadly influence motor control and reflexive actions in the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soleus H-reflex operant conditioning changes the H-reflex recruitment curve. Thompson, AK., Chen, XY., Wolpaw, JR.[2022]

References

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

Operant conditioning for management of a noncompliant rehabilitation case after stroke. [2023]

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

An operant approach to rehabilitation medicine: overcoming learned nonuse by shaping. [2022]

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

The simplest motor skill: mechanisms and applications of reflex operant conditioning. [2021]

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

An ankle-foot orthosis with inhibitor bar: effect on hemiplegic gait. [2019]

5. Australia pubmed.ncbi.nlm.nih.gov

Combining the techniques of physiotherapy and behaviour modification. [2014]

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

Anoxic encephalopathy: a neurobehavioural study in rehabilitation. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Targeted neuroplasticity for rehabilitation. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Active versus passive management of post-acquired brain injury challenging behaviour: a case study analysis of multiple operant procedures in the treatment of challenging behaviour maintained by negative reinforcement. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Operant conditioning of spinal reflexes: from basic science to clinical therapy. [2022]

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

Soleus H-reflex operant conditioning changes the H-reflex recruitment curve. [2022]