Operant Conditioning for Foot Drop Post-Stroke

Overseen By Jing Nong Liang, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nevada, Las Vegas

Disqualifiers: Cerebellar stroke, other neurological diseases

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

Compensation: Varies

Number of Visits: 36

Duration: 3 months

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how operant conditioning, a reflex training technique, can assist individuals with foot drop after a stroke. The focus is on enhancing nerve pathways in the leg muscles to improve walking ability. Participants will undergo 40 sessions over approximately four months. Ideal candidates have experienced a single stroke at least six months ago, struggle with foot drop, and can walk, even with an assistive device. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance 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. It is best to discuss this with the trial coordinators.

What prior data suggests that this operant conditioning is safe for individuals with post-stroke hemiparesis?

Research has shown that operant conditioning is safe for various conditions, such as stroke recovery and spinal cord injuries. Studies have found no safety issues with this method. By targeting specific reflexes, operant conditioning helps improve movement. This approach is generally well-tolerated and typically does not cause side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about operant conditioning for foot drop post-stroke because it offers a new way to enhance muscle control by retraining the nervous system. Unlike traditional treatments like physical therapy or functional electrical stimulation, this approach focuses on increasing the magnitude of reciprocal inhibition in the affected leg. By conditioning the nervous system to improve muscle responses, this method has the potential to provide more effective and lasting improvements in walking ability for stroke survivors.

What evidence suggests that operant conditioning is effective for foot drop post-stroke?

Research has shown that operant conditioning can help people with foot drop, a condition affecting walking after a stroke. This technique improves muscle control by enhancing a natural reflex that helps muscles in the affected leg work together. In past studies, participants walked better and experienced fewer foot drop symptoms. About two-thirds of them also showed reduced reflex activity, indicating improved muscle control. This trial will specifically test the effectiveness of reciprocal inhibition up conditioning, a form of operant conditioning, in managing foot drop after a stroke. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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

I know my treatment history for leg muscle stiffness.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Operant conditioning

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05801744

NCT05801744 | Operant Conditioning of Reflex Pathways ... By increasing the amount of reciprocal inhibition, the paretic ankle in people post-stroke may exhibit less foot drop. What is the study ...

2. withpower.com withpower.com/trial/phase-paresis-7-2022-5235a

Operant Conditioning for Foot Drop Post-Stroke 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 ...

3. wearesrna.org wearesrna.org/blog/operant-conditioning-rehabilitation-studies/

Operant Conditioning Rehabilitation Studies | SRNA Blog Initial results have seen improved walking and lessened foot drop. The third study addresses neuropathic pain after spinal cord injury. People ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3579496/

Operant Conditioning of a Spinal Reflex Can Improve ... Over the 30 sessions, the soleus H-reflex decreased in two-thirds of the DC subjects (a success rate similar to that in normal subjects) and ...

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05801744?keyword=%22Hemiparesis%22

Operant Conditioning of Reflex Pathways to Improve ... The purpose of this study is to examine the changes in reflex pathways in the paretic ankle plantarflexors in individuals with post-stroke hemiparesis using ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6095771/

Clinical Translation of Spinal Reflex Operant Conditioning Operant conditioning protocols can target beneficial plasticity to key reflex pathways; they can thereby trigger wider plasticity that improves impaired motor ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05094362

NCT05094362 | Operant Conditioning of Spinal Reflexes ... The purpose of this study is to validate the capacity of a reflex training system to change the size of the targeted reflex. For this, the researchers are ...