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Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke
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: NCT00142792
  Purpose

Stroke is the leading cause of activity limitation among older adults in the United States. NeuroMuscular Electrical Stimulation (NMES) can assist stroke survivors in regaining motor ability and decreasing activity limitation caused by stroke. This study will research the effects of two types of NMES on reducing motor impairment and activity limitation.


Condition Intervention Phase
Stroke, Acute
Stroke
Hemiparesis
Device: NMES device with EMG-triggered and Cyclic capabilities
Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: Electrical Stimulation for Upper Limb Recovery in Stroke

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

Primary Outcome Measures:
  • Fugl-Meyer Motor Assessment (FMA) - motor impairment measure [ Time Frame: FMA will be administered on 6 occasions: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Arm Motor Ability Test (AMAT) - hemiparetic arm-specific measure of activity limitation [ Time Frame: AMAT will be administered on 6 occasions as above: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment: 189
Study Start Date: December 2005
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A. Cyclic stim: Active Comparator
  • Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) 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
Device: NMES device with EMG-triggered and Cyclic capabilities
All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
B. Sensory stim: Active Comparator
Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.
Device: NMES device with EMG-triggered and Cyclic capabilities
All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
C. EMG-Triggered: Active Comparator
EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be "rewarded" with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.
Device: NMES device with EMG-triggered and Cyclic capabilities
All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.

Detailed Description:

Stroke is the leading cause of activity limitation among older adults in the United States. NeuroMuscular Electrical Stimulation (NMES) can be used by stroke survivors who do not have enough residual movement to take part in volitional active repetitive movement therapy and does not require expensive equipment or skilled personnel. Two types of NMES are available. The first is cyclic NMES, which electrically activates paretic muscles at a set duty cycle for a preset time period. (This study will employ both "traditional" cyclic stimulation and "sensory-only" stimulation, in which intensity is set at a level to be felt by the patient but insufficient to cause muscle contraction.)In cyclic NMES, the patient is a passive participant and does not assist the NMES by volitionally contracting the muscle during stimulation. The second type encompasses various forms of NMES in combination with biofeedback. For example, in "EMG-triggered" NMES, subjects are "rewarded" with stimulation in response to successful attempts to reach a pre-set level of EMG activity in the affected muscle. There is increased cognitive input and involvement on the part of the patient. The purpose of this study is to first demonstrate the effectiveness of these two types of surface stimulation on decreasing motor impairment and activity limitation; the study also seeks to assess the effect of adding cognitive input to NMES to reduce motor impairment and activity limitation.

Study subjects will be acute stroke survivors. They will participate for a total of eight months, beginning within the first six months after their stroke. Subjects will be randomly assigned to one of three treatment groups and will receive stimulation accordingly: 1) Cyclic stimulation; 2)Sensory-only stimulation; and 3)EMG-triggered stimulation. Members of each treatment group will be given an appropriate NMES device to use for two 40-minute treatment sessions per day, five times per week for eight weeks; for a total of 80 treatment sessions. Stimulation will be applied to ECR and EDC (wrist and finger extensors) on the affected arm. A treatment therapist will visit the patient at home on a weekly basis to monitor subject compliance and to provide feedback on device usage. The primary outcome measure will be the upper extremity portion of the Fugl-Meyer Motor Assessment (FMA), a measure of motor impairment. The modified Arm Motor Ability Test (mAMAT) is a hemiparetic arm-specific measure of activity limitation, and will serve as a secondary outcome measure.

In addition to the baseline visit on day of enrollment, subjects will complete these outcome measurements at the clinic on five other occasions: at mid-treatment (week 5); end of treatment (week 9); and for follow-up visits at one-, three- and six-months post-treatment.

  Eligibility

Ages Eligible for Study:   21 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 21-89
  • Evidence of clinical symptoms from a hemorrhagic or nonhemorrhagic stroke with all symptoms from previous stroke(s) completely resolved
  • Medically stable
  • Less than 6 months post-stroke
  • Intact skin on the hemiparetic side
  • Able to follow 3-stage commands
  • Able to recall 2/3 objects after 30 minutes
  • Full passive ROM at the wrist and the thumb, index and long finger MCP joints on the affected side
  • Presence of a detectable, volitionally-activated EMG signal from the paretic wrist or finger extensors (ECR or EDC)
  • Affected wrist extensors ≤ 4 on MRC scale
  • Score of ≤ 11/14 on Section C (hand) of UE portion of Fugl Meyer Assessment (FMA)
  • Ability to tolerate NMES to the ECR and EDC for full wrist and finger extension
  • Caregiver available to assist with the device every day (unless subject capable of using it independently

Exclusion Criteria:

  • History of ventricular arrythmias or any other arrythmias (i.e. fast atrial fibrillation, ventricular tachycardia, or supraventricular tachycardia) with hemodynamic instability
  • History of other upper motor neuron lesion
  • Absent sensation of the affected limb
  • Pregnancy
  • History of more than one seizure per month during the last year (or, since the stroke if no seizures prior to stroke)
  • Discharge to a skilled nursing facility or long-term care facility (EXCEPTION: Subjects may be d/c'd to the 6A SNF unit at MetroHealth Medical Center)
  • Uncompensated hemineglect
  • Implanted stimulator (such as a pacemaker)
  • Evidence of hand pain as defined by current metacarpophalangeal (MCP) joint pain upon palpation and/or wrist or MCP pain upon extension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142792

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

Locations
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Cathy Corrigan, RN     216-778-5347     ccorrigan@metrohealth.org    
Contact: Peggy Maloney, RN     216-778-5347     mmaloney@metrohealth.org    
Principal Investigator: John Chae, MD            
University of Cincinnati College of Medicine Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Stephen Page, PhD, FAHA     513-558-2754     stephen.page@uc.edu    
Principal Investigator: Stephen Page, PhD, FAHA            
Edwin Shaw Rehab - Akron General Medical Center Recruiting
Akron, Ohio, United States, 44312
Contact: James Lee, PT     330-784-1271 ext 5179     jlee@edwinshaw.com    
Principal Investigator: Michael Delahanty, DO            
Sponsors and Collaborators
Investigators
Principal Investigator: John Chae, MD MetroHealth Medical Center
  More Information

Cleveland FES Center  This link exits the ClinicalTrials.gov site
The MetroHealth System - Clinical Trials  This link exits the ClinicalTrials.gov site
Neuromotor Recovery & Rehabilitation Laboratory, Cincinnati, Ohio  This link exits the ClinicalTrials.gov site

Publications:
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.
Powell J, Pandyan AD, Granat M, Cameron M, Stott DJ. Electrical stimulation of wrist extensors in poststroke hemiplegia. Stroke. 1999 Jul;30(7):1384-9.
Francisco G, Chae J, Chawla H, Kirshblum S, Zorowitz R, Lewis G, Pang S. Electromyogram-triggered neuromuscular stimulation for improving the arm function of acute stroke survivors: a randomized pilot study. Arch Phys Med Rehabil. 1998 May;79(5):570-5.
Cauraugh J, Light K, Kim S, Thigpen M, Behrman A. Chronic motor dysfunction after stroke: recovering wrist and finger extension by electromyography-triggered neuromuscular stimulation. Stroke. 2000 Jun;31(6):1360-4.
Cauraugh JH, Kim S. Two coupled motor recovery protocols are better than one: electromyogram-triggered neuromuscular stimulation and bilateral movements. Stroke. 2002 Jun;33(6):1589-94.
Sonde L, Gip C, Fernaeus SE, Nilsson CG, Viitanen M. Stimulation with low frequency (1.7 Hz) transcutaneous electric nerve stimulation (low-tens) increases motor function of the post-stroke paretic arm. Scand J Rehabil Med. 1998 Jun;30(2):95-9.
Sonde L, Kalimo H, Fernaeus SE, Viitanen M. Low TENS treatment on post-stroke paretic arm: a three-year follow-up. Clin Rehabil. 2000 Feb;14(1):14-9.
Bowman BR, Baker LL, Waters RL. Positional feedback and electrical stimulation: an automated treatment for the hemiplegic wrist. Arch Phys Med Rehabil. 1979 Nov;60(11):497-502.
Kraft GH, Fitts SS, Hammond MC. Techniques to improve function of the arm and hand in chronic hemiplegia. Arch Phys Med Rehabil. 1992 Mar;73(3):220-7.
Kimberley TJ, Lewis SM, Auerbach EJ, Dorsey LL, Lojovich JM, Carey JR. Electrical stimulation driving functional improvements and cortical changes in subjects with stroke. Exp Brain Res. 2004 Feb;154(4):450-60. Epub 2003 Nov 15.

Responsible Party: MetroHealth Medical Center; Case Western Reserve University ( John Chae, MD )
Study ID Numbers: R01HD049777, R01HD049777
Study First Received: August 31, 2005
Last Updated: September 25, 2008
ClinicalTrials.gov Identifier: NCT00142792  
Health Authority: United States: Federal Government

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

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

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009