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Clinical Trials/NCT00369668
NCT00369668
Completed
Phase 2

Subacute Stroke Recovery (Upper Extremity Motor Function): Bimanual Coordination Training

University of Florida1 site in 1 country30 target enrollmentAugust 2006

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Cerebrovascular Accident
Sponsor
University of Florida
Enrollment
30
Locations
1
Primary Endpoint
Box and Block Test; Data Collected = Number of Blocks Moved
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

The purpose of this study was to determine the effect of two amounts of treatment therapy on post stroke motor recovery in the arms. The therapy is bilateral movement training combined with electrical stimulation on the impaired limb.

Detailed Description

Intense movement training (practice) with the affected arm after stroke has the potential to improve upper extremity (UE) function resulting from neuroplasticity 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. The current compared the effects on motor function impairments for three bilateral movement groups involving two doses of treatment (i.e., bilateral training coupled with neuromuscular electrical stimulation) and a sham control. 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 capabilities were assessed before treatment therapy began (pretest) and within the first week after the treatment therapy ended (posttest).

Registry
clinicaltrials.gov
Start Date
August 2006
End Date
June 2009
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Box and Block Test; Data Collected = Number of Blocks Moved

Time Frame: Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)

A 60 second timed hand/arm manipulation test in which participants reach, grasp, lift, and release a 1" x 1" block of wood. They must lift a block from one side of a box, carry it over a low barrier and release the block into the other side of the box.

Fugl-Meyer Upper Extremity Motor Test

Time Frame: Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)

FM motor test assesses functional impairments post stroke as participants attempt various movements from daily activities. Minimum score = 0; maximum score = 66; lower scores indicate more impairments and higher scores indicate less impairments.

Fractionated Reaction Time

Time Frame: Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)

Premotor reaction times in milliseconds were recorded for the impaired arm of each participant in the three intervention (arm) groups. Premotor reaction time represents central processes. Lower times are faster reaction times, indicating less time to initiate a movement.

Study Sites (1)

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