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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 to 12 weeks, 0 to 36 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Box and Blocks Test (BBT) change

Secondary outcome measures

Stroke Upper Limb Capacity Scale (SULCS) change

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

~1230

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

MetroHealth Medical CenterLead Sponsor

114 Previous Clinical Trials

21,257 Total Patients Enrolled

16 Trials studying Stroke

827 Patients Enrolled for Stroke

Kessler FoundationOTHER

173 Previous Clinical Trials

10,576 Total Patients Enrolled

26 Trials studying Stroke

2,341 Patients Enrolled for Stroke

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,456 Total Patients Enrolled

38 Trials studying Stroke

7,668 Patients Enrolled for Stroke

Media Library

Occupational Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03574623 — N/A

Stroke Research Study Groups: cNMES, Task Oriented Therapy, CCFES

Stroke Clinical Trial 2023: Occupational Therapy Highlights & Side Effects. Trial Name: NCT03574623 — N/A

Occupational Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03574623 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could aged individuals above 75 years partake in this research project?

"The age requirements for this clinical trial are between 21-90 years old. 48 trials cater to individuals under the age of 18, and 1034 studies are available for those aged 65 or above."

Answered by AI

Is this clinical investigation occurring extensively in our state?

"This medical trial is available at the MetroHealth Rehabilitation Institute in Cleveland, Emory University and Atlanta VA in Atlanta, Johns Hopkins University in Baltimore, as well as other 4 centres."

Answered by AI

Am I qualified to be a participant in this experiment?

"This medical trial is actively recruiting 129 patients aged between 21 and 90 who have experienced a stroke. In order to qualify, participants must be able to recall two of three items after 30 minutes; they should possess adequate active shoulder and elbow movement which allows them to position their hands in the workspace for table-top task practice; they should also be 6-24 months post first clinical cortical or subcortical hemorrhagic or nonhemorrhagic stroke with finger extensor strength of no more than 4 out of 5 on the Medical Research Council (MRC) scale, score at least 1 but not exceeding 11 out of 14 on the hand"

Answered by AI

Are there any opportunities available to volunteer for this research project?

"Affirmative. Clinicaltrials.gov showcases that this medical research project, which was initiated on February 15th 2019, is actively recruiting volunteers. Around 129 individuals are expected to be recruited from 4 sites in total."

Answered by AI

What is the total enrollment for this research project?

"Yes, indeed. Clinicaltrials.gov provides evidence that this clinical experiment is still recruiting participants after its initial posting on February 15th 2019 and latest update on July 18th 2022. Currently 4 sites are collectively seeking 129 patients for the study."

Answered by AI