Treatments for Recovery of Hand Function in Acute Stroke Survivors
NCT ID: NCT00565045
Last Updated: 2018-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
21 participants
INTERVENTIONAL
2007-07-31
2010-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CCFES
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.
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) 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
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
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) 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).
Interventions
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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) 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).
Eligibility Criteria
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Inclusion Criteria
* 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 Medical Research Council (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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Case Western Reserve University
OTHER
National Institutes of Health (NIH)
NIH
MetroHealth Medical Center
OTHER
Responsible Party
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Jayme Knutson
Assistant Professor, Physical Medicine and Rehabilitation
Principal Investigators
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Jayme S Knutson, PhD
Role: PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center
Locations
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MetroHealth Medical Center
Cleveland, Ohio, United States
Countries
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References
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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. doi: 10.1016/j.apmr.2007.01.003.
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.
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. doi: 10.1001/jama.292.15.1853.
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. doi: 10.1161/01.str.31.10.2390.
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. doi: 10.1080/096382800297097.
Related Links
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Cleveland FES Center
The MetroHealth System - Clinical Trials
Other Identifiers
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