Electrical Stimulation for Recovery of Hand Function in Chronic Stroke Survivors

October 3, 2017 updated by: Jayme Knutson, MetroHealth Medical Center

Contralaterally Controlled FES for Chronic Arm/Hand Hemiplegia: Single-Site RCT

Impaired hand function is one of the most frequently persisting consequences of stroke. The purpose of this study is to compare two different treatments -- Contralataterally Controlled Functional Electrical Stimulation (CCFES) and Cyclic Neuromuscular Electrical Stimulation (cNMES) -- for improved recovery of hand function after stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hemiparesis of the upper limb is one of the most serious and most common impairments resulting from stroke. Approximately 75% of the over 750,000 strokes that occur annually in the United States cause some degree of upper extremity paralysis. Approximately 65% of stroke survivors still cannot use their affected hand to assist with activities of daily living 6 months after their stroke. The impact of upper extremity impairments on disability and health is great, yet there are relatively few rehabilitation interventions designed to restore function to the impaired upper limb. Therefore, our long-term objective is to develop upper extremity rehabilitation therapies that are effective at restoring arm and hand function, that are applicable across a wide range of impairment severity, and that are readily implemented in the present healthcare environment.

The purpose of this study is to estimate the efficacy of Contralataterally Controlled Functional Electrical Stimulation (CCFES) in reducing upper extremity impairment and activity limitation in chronic upper extremity hemiplegia. CCFES is a rehabilitation intervention in which neuromuscular electrical stimulation (NMES) is applied to the finger and thumb extensor muscles of the paretic upper limb to open the hand. The stroke survivor controls the stimulation intensity, and consequent degree of hand opening, by modulating the degree of opening of the contralateral unimpaired hand, which is detected by an instrumented glove. Thus, volitional opening of the unaffected hand produces stimulated opening of the affected hand. The stimulation paradigm is used to assist the stroke survivor in practicing functional tasks with their affected hand. We will conduct a randomized controlled trial in which chronic stroke survivors (>6 months post-stroke) will be randomly assigned to receive 12 weeks of CCFES or cyclic NMES, an intervention that provides electrical stimulation of the hand extensors, but with preprogrammed timing and intensity. Randomization will be stratified on two levels of baseline hand impairment defined by the degree of voluntary finger extension present. Assessments of upper extremity impairment and activity limitation will be made every 3 weeks during the treatment period and every 2 months during a 6-month follow-up period.

This study is the first randomized controlled trial of CCFES in chronic upper extremity hemiplegia. Ultimately, the information learned in this study will serve to accelerate the development of treatments for reducing post-stroke disability.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-80
  • > 6 months of first hemorrhagic or nonhemorrhagic stroke
  • Able to recall 2 of 3 items after 30 minutes
  • MRC ≤ 4 for finger extensors on paretic side
  • Able to follow 3-stage commands
  • Functional movement of shoulder and elbow (e.g., can reach ¾ hand-to- mouth movement) of paretic side
  • Caregiver available to assist with device and compliance if needed
  • Skin intact on hemiparetic arm
  • Medically stable
  • Surface NMES trial opens hand without pain
  • Full volitional hand opening/closing of contralateral hand
  • Upper extremity hand section of FMA < 11/14
  • Able to hear and respond to stimulator/cue box auditory cues
  • Completed occupational therapy (no concomitant OT)

Exclusion Criteria:

  • Lack of functional PROM of the wrist or fingers of affected side
  • Severe shoulder or hand pain (unable to position hand in the workspace without pain)
  • Uncontrolled seizure disorder
  • Insensate forearm and/or hand
  • Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
  • Edema of the affected forearm and/or hand
  • History of cardiac arrhythmias with hemodynamic instability
  • Cardiac pacemaker or other implanted electronic system
  • Pregnant
  • IM Botox injections in any UE muscle in the last 3 months
  • Parkinson's disease, SCI, TBI, or MS
  • Ipsilateral motor neuron lesion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CCFES

CCFES - Contralaterally Controlled Functional Electrical Stimulation

  • Electrical stimulator
  • Stimulation to finger and thumb extensors only in response to, and with an intensity proportional to, opening of the contralateral unimpaired hand.
  • A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity.
  • Therapy sessions are done with the subject being assisted by the CCFES system.
Device: Electrical stimulator

• 12-week intervention

  1. Therapist-guided task practice performed twice a week in the research laboratory. (Device used for CCFES group but not for cNMES group during these sessions.)
  2. Self-administered CCFES or cNMES-mediated hand opening exercise performed 10 sessions per week at home.
ACTIVE_COMPARATOR: cNMES

cNMES - Cyclic NeuroMuscular Electrical Stimulation

  • Electrical stimulator
  • Preprogrammed cycles of finger and thumb extensor stimulation repeatedly and automatically open the hand.
  • Subject instructed to not move the contralateral arm/hand during stimulation.
  • Therapy sessions are done without the stimulation system.
Device: Electrical stimulator

• 12-week intervention

  1. Therapist-guided task practice performed twice a week in the research laboratory. (Device used for CCFES group but not for cNMES group during these sessions.)
  2. Self-administered CCFES or cNMES-mediated hand opening exercise performed 10 sessions per week at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Box and Block Test Score at 6 Mo Post-Treatment
Time Frame: 2 timepoints: Prior to treatment, and 6 months after completion of treatment.

The Box and Blocks test counts how many times the participant can pick up 1 block at t time, move it over a partition, and release it in a target area within 60 seconds.

The minimum score is 0. There is no maximum score. The average score of healthy individuals within the age range of this study ranges from 70 to 79.

Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at 6 months after completion of treatment. Then for each treatment group, these change scores were averaged.
2 timepoints: Prior to treatment, and 6 months after completion of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Arm Motor Abilities Test Score at 6-Month Post-Treatment
Time Frame: 2 timepoints: Prior to treatment, and 6 months after completion of treatment.

The Arm Motor Abilities Test assesses the participant's ability to execute specific upper limb tasks and does not allow for compensation with the unimpaired side. The test consists of 9 compound tasks composed of 1 to 3 component tasks, each of which is rated on a 0 - 5 ordinal scale: 0, no attempt to use affected limb; 1, attempt to use affected limb but it does not participate functionally; 2, affected limb is used only as a helper or stabilizer; 3, affected limb is used slowly or within synergy patterns; 4, almost normal use of affected limb; 5, normal use. The final score is the average of all component task scores across all 9 compound tasks.

The minimum score is 0; maximum score is 5. Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at 6 months after completion of treatment. Then for each treatment group, these change scores were averaged.
2 timepoints: Prior to treatment, and 6 months after completion of treatment.
Change in Upper Extremity Fugl-Meyer Score at 6-Months Post-Treatment
Time Frame: 2 timepoints: Prior to treatment, and 6 months after completion of treatment.

The Upper Extremity Fugl-Meyer (UEFM) Assessment is a measure of upper limb motor impairment. Participants are asked to attempt to perform a list of very specific movements of the arm, elbow, forearm, wrist, and hand that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 66, minimum score of 0.

Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at 6 months after completion of treatment. Then for each treatment group, these change scores were averaged.
2 timepoints: Prior to treatment, and 6 months after completion of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetroHealth Medical Center

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

September 25, 2008

First Submitted That Met QC Criteria

April 30, 2009

First Posted (ESTIMATE)

May 1, 2009

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HD059814 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe