| August 24, 2006 |
| February 17, 2009 |
| August 2006 |
| June 2009 (final data collection date for primary outcome measure) |
- Fugl-Meyer Upper Extremity Motor Test [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Box and Block Test [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Wolf Motor Function Test [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Fractionated Reaction Time and Sustained Muscle Contraction [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
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- Fugl-Meyer Upper Extremity Motor Test
- Box and Block Test
- Wolf Motor Function Test
- Fractionated Reaction Time and Sustained Muscle Contraction
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| Complete list of historical versions of study NCT00369668 on ClinicalTrials.gov Archive Site |
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| Effects of Different Amounts of Electrical Stimulation + Bilateral Practice on Improving Hand Function After Stroke |
| Subacute Stroke Recovery (Upper Extremity Motor Function): Bimanual Coordination Training |
The purpose of this study is to compare how well providing 2 different amounts of therapy, electrical stimulation to the arm/hand muscles plus bilateral practice using the arms/hands, for the weaker arm and hand after stroke facilitates arm and hand function. |
"Intense skill practice with the affected arm after stroke has the potential to improve upper extremity (UE) function resulting from neuroplastic changes in the motor cortex. However, the necessary and sufficient parameters of this therapy in humans have not been fully investigated. Delineation of the most efficacious and efficient therapy for promoting UE recovery post-stroke is necessary before effective clinical implementation of this therapy. In this study, using parallel group design methodology, we will compare the effects on motor function of 2 doses of neuromuscular electric stimulation coupled with bilateral motor practice. During the subacute recovery phase (3 - 6 months), patients who meet motor capabilities criteria will be randomly assigned to one of three groups: (a) low intensity (90 minutes/session, 2 sessions/week 2 weeks) bilateral movement training coupled with active neuromuscular stimulation on the impaired wrist/fingers (b) high intensity (90 minutes/session, 4 sessions/week for 2 weeks) bilateral movement training coupled with active stimulation on the impaired wrist/finger extensors, and (c) control group (sham active stimulation). Patients' UE motor skills will be tested prior to therapy, within the first week after the therapy program and 2 months after treatment ends.
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| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study |
- Cerebrovascular Accident
- Hemiplegia
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- Behavioral: Bilateral movement practice + neuromuscular electrical stimulation
- Behavioral: bilateral motor practice + neuromuscular electrical stimulation
- Behavioral: Sham electrical stimulation + bilateral motor practice
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- Experimental: Bilateral practice moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
- Active Comparator: bilateral practice moving the arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
- Active Comparator: Bilateral motor practice coupled with sham neuromuscular electrical stimulation
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| Recruiting |
| 44 |
| July 2009 |
| June 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- an ability to complete 10º of wrist or finger extension from a 60 - 65 º flexed position
- score less than a 56 on the UE subscale of the Fugl-Meyer Assessment
- an ability to voluntarily activate slight movements in the wrist and fingers so that the EMG activity reaches a minimal level on the microprocessor for electrical stimulation to be activated
- unilateral, first stroke of ischemic or hemorrhagic origin in the carotid artery distribution
- free of major post stroke complications
- able to attend therapy 2 days/week or 4 days/week for 2 weeks
- score at least a 16 on the Mini Mental Status Examination
- able to discriminate sharp from dull and light touch using traditional sensation tests.
Exclusion Criteria:
- hemiparetic arm is insensate
- motor impairments from stroke on opposite side of body
- pre-existing neurological disorders such as Parkinson's disease, Multiple Sclerosis, or dementia
- Legal blindness or severe visual impairment; 5) Life expectancy less than one year
- Severe arthritis or orthopedic problems that limit passive ranges of motion of upper extremity (passive finger extension < 40º; passive wrist extension < 40º; passive elbow extension <40º; shoulder flexion/abduction < 80º)
- History of sustained alcoholism or drug abuse in the last six months
- Has pacemaker or other implanted device
- pregnant
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| Both |
| 44 Years to 86 Years |
| No |
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| United States |
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| NCT00369668 |
| James Cauraugh, Ph.D., University of Florida |
| 00061194, 1R03HD4453401A2 |
| University of Florida |
| National Institutes of Health (NIH) |
| Principal Investigator: |
James H. Cauraugh, Ph.D. |
University of Florida |
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| University of Florida |
| February 2009 |