Electrical Stimulation for Recovery of Hand Function in Chronic Stroke Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Information provided by (Responsible Party):
Jayme Knutson, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00891319
First received: September 25, 2008
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Stroke
Hemiparesis
Hemiplegia
Device: Electrical stimulator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Contralaterally Controlled FES for Chronic Arm/Hand Hemiplegia: Single-Site RCT

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Box and Block Test [ Time Frame: 8 times: Prior to treatment, every 3 weeks during treatment, at the end of treatment, and at 2, 4, and 6 months after completion of treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Arm Motor Abilities Test [ Time Frame: 8 times: Prior to treatment, every 3 weeks during treatment, at the end of treatment, and at 2, 4, and 6 months after completion of treatment. ] [ Designated as safety issue: No ]
  • Fugl-Meyer Motor Assessment (upper limb motor impairment component) [ Time Frame: 8 times: Prior to treatment, every 3 weeks during treatment, at the end of treatment, and at 2, 4, and 6 months after completion of treatment. ] [ Designated as safety issue: No ]
  • Active range of finger extension [ Time Frame: 8 times: Prior to treatment, every 3 weeks during treatment, at the end of treatment, and at 2, 4, and 6 months after completion of treatment. ] [ Designated as safety issue: No ]
  • Finger extension tracking accuracy [ Time Frame: 8 times: Prior to treatment, every 3 weeks during treatment, at the end of treatment, and at 2, 4, and 6 months after completion of treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: January 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 hand opening exercise performed twice a day, 5 days a week at home using the device.
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 hand opening exercise performed twice a day, 5 days a week at home using the device.

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. Pilot studies of CCFES in chronic hemiplegia were encouraging. This project will expand on the work already begun by: 1) determining if 12 weeks of CCFES is therapeutically effective in chronic stroke survivors, 2) determining if a plateau in treatment effect is achieved before 12 weeks is completed, 3) determining how initial level of motor impairment affects treatment efficacy, and 4) determining whether therapeutic gains persist over time. We will conduct a randomized controlled trial in which 102 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891319

Contacts
Contact: Peggy Maloney, RN 216-957-3558 mmaloney@metrohealth.org

Locations
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Peggy Maloney, RN    216-957-3558    mmaloney@metrohealth.org   
Principal Investigator: Jayme S. Knutson, Ph.D.         
Sub-Investigator: John Chae, M.D.         
Sponsors and Collaborators
Investigators
Principal Investigator: Jayme S. Knutson, PhD Case Western Reserve University
  More Information

Additional Information:
Publications:
Responsible Party: Jayme Knutson, Assistant Professor, Physical Medicine and Rehabilitation, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00891319     History of Changes
Other Study ID Numbers: R01HD059814
Study First Received: September 25, 2008
Last Updated: June 4, 2014
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
hand
stroke
hemiplegia
electrical stimulation
recovery

Additional relevant MeSH terms:
Hemiplegia
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014