Electrical Stimulation + Occupational Therapy for Stroke Recovery

Recruiting at 3 trial locations

Overseen By Amanda Khoudary

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Must not be taking: Botulinum toxin

Disqualifiers: Peripheral nerve injury, Parkinson's, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

132 Participants Needed

Trial Summary

What is the purpose of this trial?

After a stroke, it is very common to lose the ability to open the affected hand. The purpose of this study is to compare the effects of three different therapies on recovery of hand function after stroke and determine if any one is better than the other.

Research Team

Jayme Knutson, PhD

Principal Investigator

MetroHealth Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I had a stroke between 6 and 24 months ago.

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

You can hear and respond to signals from the device.

Exclusion Criteria

Deficits in communication that interfere with reasonable study participation

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

I have severe pain in my shoulder or hand.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 weeks of therapy using CCFES, cNMES, or Task Oriented Training, with 10 self-administered sessions per week at home and 2 occupational therapy sessions per week in the lab

12 weeks

2 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 12 and 36 weeks

24 weeks

Treatment Details

Interventions

• Electrical Stimulator
• Occupational Therapy

Trial Overview 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.

Participant Groups

Group I: CCFES Experimental Treatment 2 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: cNMES Active Control 2 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 Therapy Active Control 1 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.

Occupational Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Occupational Therapy for:

• Rehabilitation
• Physical disabilities
• Mental health conditions
• Cancer-related fatigue

Approved in European Union as Occupational Therapy for:

• Rehabilitation
• Physical disabilities
• Mental health conditions
• Cancer-related fatigue

Approved in Canada as Occupational Therapy for:

• Rehabilitation
• Physical disabilities
• Mental health conditions
• Cancer-related fatigue

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

Kessler Foundation

Collaborator

Trials

190

Recruited

11,300+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+