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Effects of Different Amounts of Electrical Stimulation + Bilateral Practice on Improving Hand Function After Stroke
This study is currently recruiting participants.
Study NCT00369668   Information provided by University of Florida
First Received: August 24, 2006   Last Updated: February 17, 2009   History of Changes

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 ]
  • Fugl-Meyer Upper Extremity Motor Test
  • Box and Block Test
  • Wolf Motor Function Test
  • Fractionated Reaction Time and Sustained Muscle Contraction
Complete list of historical versions of study NCT00369668 on ClinicalTrials.gov Archive Site
 
 
 
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.

"

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study
  • Cerebrovascular Accident
  • Hemiplegia
  • Behavioral: Bilateral movement practice + neuromuscular electrical stimulation
  • Behavioral: bilateral motor practice + neuromuscular electrical stimulation
  • Behavioral: Sham electrical stimulation + bilateral motor practice
  • 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

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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
Both
44 Years to 86 Years
No
Contact: James H Cauraugh, Ph.D. 352-392-0584 ext 1273 jcaura@hhp.ufl.edu
Contact: Lorie G. Richards, Ph.D. 352-376-1611 ext 5508 lrichard@phhp.ufl.edu
United States
 
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
University of Florida
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP