Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke
NCT ID: NCT00142792
Last Updated: 2018-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
122 participants
INTERVENTIONAL
2005-12-31
2010-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A. Cyclic stim
* 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
* Uses NMES device with EMG-triggered and Cyclic capabilities
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
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.
Uses NMES device with EMG-triggered and Cyclic capabilities
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
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.
Uses NMES device with EMG-triggered and Cyclic capabilities
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
21 Years
89 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Case Western Reserve University
OTHER
MetroHealth Medical Center
OTHER
Responsible Party
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John Chae, MD
Prof Vice Chair Physical Medicine and Rehabilitation
Principal Investigators
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John Chae, MD
Role: PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center
Locations
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Edwin Shaw Rehab - Akron General Medical Center
Akron, Ohio, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Countries
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References
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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. doi: 10.1016/s0003-9993(96)90293-2.
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. doi: 10.1161/01.str.29.5.975.
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. doi: 10.1161/01.str.30.7.1384.
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. doi: 10.1016/s0003-9993(98)90074-0.
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. doi: 10.1161/01.str.31.6.1360.
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. doi: 10.1161/01.str.0000016926.77114.a6.
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. doi: 10.1080/003655098444192.
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. doi: 10.1191/026921500673534278.
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. doi: 10.1007/s00221-003-1695-y. Epub 2003 Nov 15.
Wilson RD, Page SJ, Delahanty M, Knutson JS, Gunzler DD, Sheffler LR, Chae J. Upper-Limb Recovery After Stroke: A Randomized Controlled Trial Comparing EMG-Triggered, Cyclic, and Sensory Electrical Stimulation. Neurorehabil Neural Repair. 2016 Nov;30(10):978-987. doi: 10.1177/1545968316650278. Epub 2016 May 24.
Related Links
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Cleveland FES Center
The MetroHealth System - Clinical Trials
Neuromotor Recovery \& Rehabilitation Laboratory, Cincinnati, Ohio
Other Identifiers
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