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Electrical Stimulation + Occupational Therapy for Stroke Recovery

N/A

Waitlist Available

Led By Jayme Knutson, PhD

Research Sponsored by MetroHealth Medical Center

Eligibility Criteria Checklist

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

Must have

Skin intact on the hemiparetic arm

Full voluntary opening/closing of the contralateral (less affected) hand

Must not have

Diagnosis (apart from stroke) that substantially affects paretic arm and hand function

Severe shoulder or hand pain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 to 12 weeks, 0 to 36 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing three different therapies to see which is better at helping people recover hand function after a stroke.

Who is the study for?

This trial is for adults who've had their first stroke 6-24 months ago, leading to hand weakness but can still open their other hand fully. They should be able to follow instructions and have no severe pain when using a finger stimulator. Excluded are those with other neurological issues, uncontrolled seizures, certain heart conditions, pregnancy, or visual/hearing impairments that would affect participation.

What is being tested?

The study compares three therapies aimed at improving hand function after a stroke: an electrical stimulator designed to help move fingers and thumb; occupational therapy; and possibly a combination of both. It seeks to find out which method might be most effective in aiding recovery.

What are the potential side effects?

Potential side effects may include discomfort or skin irritation from the electrical stimulator's use on the arm. Occupational therapy generally has minimal risks but could cause fatigue or muscle soreness due to repetitive exercises.

Eligibility Criteria

Inclusion Criteria

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

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The skin on my weaker arm is not broken or damaged.

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I can fully open and close my less affected hand.

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My hand mobility score is between 1 and 11 on a specific test.

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I can move my shoulder and elbow well enough to use my hand for table-top tasks.

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Stimulating my weak hand's muscles can open it without pain.

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My arm is weak but I can move my fingers partially.

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I can understand and follow three-step instructions.

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I can remember at least 2 out of 3 items after half an hour.

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I am not currently undergoing occupational therapy.

Exclusion Criteria

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

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I have a condition that significantly impacts the function of my affected arm and hand, not caused by a stroke.

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I have severe pain in my shoulder or hand.

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I have had serious heart rhythm problems that affected my blood pressure.

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I have a neurological condition like MS, Parkinson's, or a spinal cord injury.

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I cannot feel my forearm or hand.

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I have had a stroke in the brainstem.

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I have seizures that are not controlled by medication.

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I cannot move my wrist or fingers on one side without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 12 weeks, 0 to 36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 to 12 weeks, 0 to 36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 12 weeks, 0 to 36 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Box and Blocks Test (BBT) change

Secondary study objectives

Stroke Upper Limb Capacity Scale (SULCS) change

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: CCFESExperimental Treatment2 Interventions

Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.

Group II: cNMESActive Control2 Interventions

Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.

Group III: Task Oriented TherapyActive Control1 Intervention

Task Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Electrical Stimulator

2013

N/A

~70

Occupational Therapy

2011

Completed Phase 3

~1200