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Treatments for Recovery of Hand Function in Acute Stroke Survivors
This study is currently recruiting participants.
Verified by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), August 2008
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00565045
  Purpose

Impaired hand function is one of the most frequently persisting consequences of stroke. The purpose of this study is to investigate whether two different types of treatment improve recovery of hand function after stroke.


Condition Intervention Phase
Stroke, Acute
Stroke
Hemiparesis
Hemiplegia
 Device: Neuromuscular electrical stimulator
 Phase I
Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: Contralaterally Controlled Functional Electrical Stimulation for Hemiparetic Hand

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

Primary Outcome Measures:
  • Active range of motion of finger extension (a measure of hand impairment) and Arm Motor Abilities Test (AMAT - a measure of upper limb activity limitation) [ Time Frame: These assessments will be administered on 4 occasions: at baseline, end of treatment, and follow-up assessments at 1 month and 3 months post-treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Isometric finger extension moment, finger flexor tone, finger extension tracking accuracy, upper extremity Fugl-Meyer motor assessment, the box and block test. [ Time Frame: These assessments will be administered on 4 occasions: at baseline, end of treatment, and follow-up assessments at 1 month and 3 months post-treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: July 2007
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CCFES: Experimental

CCFES - Contralaterally Controlled Functional Electrical Stimulation

  • Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing 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: Neuromuscular electrical stimulator

Intervention Characteristics Common to Both Groups

• 6-week intervention

  1. Home "exercise", daily

    1. Exercise (at home) 2 sessions/day
    2. A "session" consists of 3 (for CCFES and BSV) or 4 (for cNMES) 15-min sets separated by 5 min rest
    3. A "set" entails hand opening, closing, and relaxing in response or synchrony to light and sound cues and according to group-specific instructions

  2. Lab "therapy", 2x/week

    1. Two 1.5-hr sessions/week, working on functional hand tasks and tracking task (if possible).
cNMES: Active Comparator

cNMES - Cyclic NeuroMuscular Electrical Stimulation.

  • Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
  • Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
  • Therapy sessions are done without the stimulation system
 Device: Neuromuscular electrical stimulator

Intervention Characteristics Common to Both Groups

• 6-week intervention

  1. Home "exercise", daily

    1. Exercise (at home) 2 sessions/day
    2. A "session" consists of 3 (for CCFES and BSV) or 4 (for cNMES) 15-min sets separated by 5 min rest
    3. A "set" entails hand opening, closing, and relaxing in response or synchrony to light and sound cues and according to group-specific instructions

  2. Lab "therapy", 2x/week

    1. Two 1.5-hr sessions/week, working on functional hand tasks and tracking task (if possible).

Detailed Description:

Loss of hand function is common after stroke. Previous research suggests that treatments that focus on movement of both hands at the same time or treatments that electrically stimulate the paretic (weak) hand muscles may help the recovery of hand function after stroke. In this study, two electrical stimulation treatments will be compared in their effectiveness in restoring hand movement and hand function. One of the treatments is stimulation only, and the other is stimulation linked to movement of the contralateral hand.

Study participants will be stroke survivors who are enrolled while they are still within their first 6 months after their stroke. After enrolling, their hand movement and function will be tested. Then they will be randomly assigned to one of the two treatments. Each treatment will last 6 weeks. The treatment will require the participant to perform specific exercises at home for a total of 2 hours every day and to come to the laboratory twice a week for study-related occupational therapy. At the end of the 6-week treatment, tests of hand movement and hand function will be repeated. The same tests will be repeated again at 1 and 3 months after the end of treatment to see if the effects of the treatment persist as time goes on. Changes in upper extremity impairment and activity limitation will be compared across treatment groups.

  Eligibility

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

Inclusion Criteria:

  • Age 18 to 80
  • Within 6 months of first clinical hemorrhagic or nonhemorrhagic stroke
  • Cortical or subcortical stroke
  • Unilateral upper extremity hemiparesis with severe finger extensor and flexor paresis (<= grade 4 on MRC scale)
  • Adequate movement of the shoulder and elbow to allow volitional positioning of the affected hand in the workspace.
  • Surface NMES of finger and thumb extensors produces functional hand opening without pain
  • Full volitional opening of the contralateral hand of the unimpaired side.
  • Able to follow 3 stage commands
  • Able to remember at least 2 of 3 items after 30 minutes
  • Able to hear and respond (by opening the less affected hand) to auditory cues issued from the stimulator?
  • Caregiver available and willing to help assist with the device and home regimen and ensure compliance
  • Skin intact on hemiparetic arm
  • Medically stable

Exclusion Criteria:

  • Insensate forearm and/or hand
  • Edema of the affected forearm and/or hand
  • History of potentially fatal cardiac arrhythmias.
  • Cardiac pacemakers or any other implanted electronic systems
  • Pregnant women
  • Uncontrolled seizure disorder
  • Severely impaired cognition or comprehension
  • Uncompensated hemineglect
  • Severe depression (>= 13 on Beck Depression Inventory Fast Screen)
  • Ipsilateral lower motor neuron lesion
  • Parkinson's Disease
  • Spinal cord injury
  • Traumatic brain injury
  • Multiple sclerosis
  • Lack of functional passive range of motion of the wrist or fingers of affected side
  • Severe shoulder or hand pain (unable to volitionally position hand in the workspace without pain)
  • Intramuscular botulinum toxin injections in upper extremity muscle in the last 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565045

Contacts
Contact: Peggy Maloney, RN 216-778-5347 mmaloney@metrohealth.org
Contact: Cathy Corrigan, RN 216-778-5347 ccorrigan@metrohealth.org

Locations
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Peggy Maloney, RN     216-778-5347     mmaloney@metrohealth.org    
Contact: Cathy Corrigan, RN     216-778-5347     ccorrigan@metrohealth.org    
Principal Investigator: Jayme S Knutson, PhD            
Sub-Investigator: John Chae, MD            
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Jayme S Knutson, PhD Case Western Reserve University
  More Information

Cleveland FES Center  This link exits the ClinicalTrials.gov site
The MetroHealth System - Clinical Trials  This link exits the ClinicalTrials.gov site

Publications:
Knutson JS, Harley MY, Hisel TZ, Chae J. Improving hand function in stroke survivors: a pilot study of contralaterally controlled functional electric stimulation in chronic hemiplegia. Arch Phys Med Rehabil. 2007 Apr;88(4):513-20.
Glanz M, Klawansky S, Stason W, Berkey C, Chalmers TC. Functional electrostimulation in poststroke rehabilitation: a meta-analysis of the randomized controlled trials. Arch Phys Med Rehabil. 1996 Jun;77(6):549-53.
Chae J, Bethoux F, Bohine T, Dobos L, Davis T, Friedl A. Neuromuscular stimulation for upper extremity motor and functional recovery in acute hemiplegia. Stroke. 1998 May;29(5):975-9.
Luft AR, McCombe-Waller S, Whitall J, Forrester LW, Macko R, Sorkin JD, Schulz JB, Goldberg AP, Hanley DF. Repetitive bilateral arm training and motor cortex activation in chronic stroke: a randomized controlled trial. JAMA. 2004 Oct 20;292(15):1853-61. Erratum in: JAMA. 2004 Nov 24;292(20):2470.
Whitall J, McCombe Waller S, Silver KH, Macko RF. Repetitive bilateral arm training with rhythmic auditory cueing improves motor function in chronic hemiparetic stroke. Stroke. 2000 Oct;31(10):2390-5. Erratum in: Stroke. 2007 May;38(5):e22.
Mudie MH, Matyas TA. Can simultaneous bilateral movement involve the undamaged hemisphere in reconstruction of neural networks damaged by stroke? Disabil Rehabil. 2000 Jan 10-20;22(1-2):23-37.

Responsible Party: Case Western Reserve University ( Jayme S. Knutson, PhD )
Study ID Numbers: R21HD054749, R21HD054749
Study First Received: November 27, 2007
Last Updated: October 28, 2008
ClinicalTrials.gov Identifier: NCT00565045  
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

Study placed in the following topic categories:
Hemiplegia
Paresis
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
 Cerebrovascular Disorders
Paralysis
Signs and Symptoms
Brain Ischemia
Neurologic Manifestations
Brain Infarction
Infarction

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009



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