What side effects are associated with this type of intervention?

Common treatments for foot drop include physical therapy, functional electrical stimulation (FES), and orthotic devices. Physical therapy and operant conditioning, which aim to modify neural pathways and reflexes, generally have minimal side effects but may include muscle soreness and fatigue. Functional electrical stimulation can cause skin irritation, discomfort, and muscle fatigue. Orthotic devices, such as ankle-foot orthoses (AFOs), may lead to skin irritation, discomfort, and potential muscle atrophy if overused.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for foot drop that directly align with the operant conditioning of neural pathways and reflexes as described in the trial. However, treatments for foot drop generally include physical therapy, functional electrical stimulation (FES), and ankle-foot orthoses (AFOs). FES, which involves electrical stimulation to improve muscle function, is somewhat related to neural modulation techniques. These treatments aim to improve mobility and muscle control in individuals with foot drop.

What other types of research exist?

Promising novel alternatives to operant conditioning for foot drop patients include: 1) Multimodal training targeting cognitive components of motor actions, which has shown to improve gait and reduce fall rates. 2) Transcranial Direct Current Stimulation (tDCS) combined with motor learning-based virtual reality-assisted therapy, which has demonstrated significant improvements in gait function. 3) Spinal cord stimulation, which has been effective in managing chronic pain and improving quality of life, and may offer benefits for motor function.

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Behavioral Intervention

Operant Conditioning for Foot Drop Post-Stroke

N/A

Recruiting

Research Sponsored by University of Nevada, Las Vegas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 6 months following a single, unilateral stroke, resulting in hemiparesis

All subjects will be adults at least 18 years old

Must not have

No other neurological disease or injuries other than the stroke affecting the use of the legs and/or walking

Cerebellar stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention focuses on behavioral training rather than medication or surgery, side effects are minimal but may include fatigue or discomfort from repetitive exercises during the conditioning sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am at least 18 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had a stroke in the cerebellum.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Reciprocal inhibition up conditioningExperimental Treatment1 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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Foot Drop include physical therapy, electrical stimulation, and orthotic devices. Physical therapy focuses on strengthening the muscles and improving coordination, which can help restore some degree of normal function. Electrical stimulation works by activating the nerves and muscles in the affected area, promoting muscle contraction and improving muscle strength. Orthotic devices, such as ankle-foot orthoses (AFOs), provide support and maintain proper foot positioning. Operant conditioning, as studied in the trial, aims to modify neural pathways and reflexes to improve motor control and walking ability. This is particularly important for Foot Drop patients as it addresses the underlying neural deficits, potentially leading to more sustainable and long-term improvements in mobility and function.

Use of electrical stimulation and exercise to increase muscle strength in a patient after surgery for cervical spondylotic myelopathy.