NCT00142792|CompletedResults
Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke
Electrical Stimulation for Upper Limb Recovery in Stroke
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Electrical Stimulation for Upper Limb Recovery in Stroke
Sponsor study identifier
NIH
Secondary identifiers
NIH
interventional
122
1 country
3
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2010
Actual (reported)Study Completion
March 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 31, 2005
Actual (reported)September 2, 2005
Actual (reported)December 2005
Date type not reportedThis date has not been verified as actual or estimated.
March 2010
Actual (reported)March 2010
Actual (reported)March 29, 2018
Actual (reported)Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure
The FMA battery measures six dimensions of post-stroke impairment including upper and lower limb motor impairment, range of motion, pain, reflexes, and sensation. , "Each item (33 total) is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and summed to provide a score ranging from 0 to 66, where higher scores indicate better motor function The FMA was administered with the participant seated.
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.
Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation
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.
* 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
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Edwin Shaw Rehab - Akron General Medical Center
Akron, Ohio, 44312, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
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.
the estimated sample size needed to reach 90% power to detect clinically meaningful differences within the groups was not met due to slow recruitment. The lower power creates the possibility that a type II error was made.
John Chae, MD
MetroHealth Medical Center
122 participants (actual enrollment reported by the registry).
First Submitted
August 31, 2005
First Posted
September 2, 2005
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis
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
Contact the study team to confirm eligibility.
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.
Primary Completion
March 2010
Actual (reported)Study Completion
March 2010
Actual (reported)Last Updated
March 29, 2018
Results First Posted
March 29, 2018
Record last verified: 2018-03
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