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

September 25, 2008
June 4, 2014
January 2009
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00891319 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Electrical Stimulation for Recovery of Hand Function in Chronic Stroke Survivors
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke
  • Hemiparesis
  • Hemiplegia
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.
  • 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.
    Intervention: Device: Electrical stimulator
  • 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.
    Intervention: Device: Electrical stimulator

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
102
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Peggy Maloney, RN 216-957-3558 mmaloney@metrohealth.org
United States
 
NCT00891319
R01HD059814
No
Jayme Knutson, Case Western Reserve University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Jayme S. Knutson, PhD Case Western Reserve University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP