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Effects of Different Amounts of Electrical Stimulation + Bilateral Practice on Improving Hand Function After Stroke
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Florida.   Recruitment status was  Recruiting

First Received on August 24, 2006.   Last Updated on February 17, 2009   History of Changes
Sponsor: University of Florida
Collaborator: National Institutes of Health (NIH)
Information provided by: University of Florida
ClinicalTrials.gov Identifier: NCT00369668
  Purpose

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.


Condition Intervention Phase
Cerebrovascular Accident
Hemiplegia
 Behavioral: Bilateral movement practice + neuromuscular electrical stimulation
Behavioral: bilateral motor practice + neuromuscular electrical stimulation
Behavioral: Sham electrical stimulation + bilateral motor practice
 Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Subacute Stroke Recovery (Upper Extremity Motor Function): Bimanual Coordination Training

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 44
Study Start Date: August 2006
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Intensity
Bilateral practice moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
 Behavioral: Bilateral movement practice + neuromuscular electrical stimulation
Participants practice moving their paretic arm at the same time as they move their non-paretic arm in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the motion
Other Name: functional electrical stimulation
Active Comparator: low intensity
bilateral practice moving the arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
 Behavioral: bilateral motor practice + neuromuscular electrical stimulation
Participants will practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own muscle contractions are provided to the paretic arm during the movements.
Other Name: functional electrical stimulation
Active Comparator: Control
Bilateral motor practice coupled with sham neuromuscular electrical stimulation
 Behavioral: Sham electrical stimulation + bilateral motor practice
Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Sham electrical stimulation (low level electrical stimulation that can be felt but is insufficient to trigger a muscle contraction) is provided to the paretic arm during the movement
Other Name: functional electrical stimulation - sham

Detailed Description:

"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.

"

  Eligibility

Ages Eligible for Study:   44 Years to 86 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00369668

Contacts
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

Locations
United States, Florida
Motor Behavior Laboratory, University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: James H. Cauraugh, Ph.D.     352-392-0584 ext 1273     cjaura@hhp.ufl.edu    
Contact: Lorie G. Richards, Ph.D.     352-376-1611 ext 5508     lrichard@phhp.ufl.edu    
Principal Investigator: James H Cauraugh, Ph.D.            
Sub-Investigator: Lorie G. Richards, Ph.D.            
Sponsors and Collaborators
University of Florida
National Institutes of Health (NIH)
Investigators
Principal Investigator: James H. Cauraugh, Ph.D. University of Florida
  More Information

Publications:
Cauraugh JH, Kim SB. Stroke motor recovery: active neuromuscular stimulation and repetitive practice schedules. J Neurol Neurosurg Psychiatry. 2003 Nov;74(11):1562-6.
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.
Cauraugh JH, Kim SB. Chronic stroke motor recovery: duration of active neuromuscular stimulation. J Neurol Sci. 2003 Nov 15;215(1-2):13-9.
Liepert J, Uhde I, Graf S, Leidner O, Weiller C. Motor cortex plasticity during forced-use therapy in stroke patients: a preliminary study. J Neurol. 2001 Apr;248(4):315-21.

Responsible Party: James Cauraugh, Ph.D., University of Florida
ClinicalTrials.gov Identifier: NCT00369668     History of Changes
Other Study ID Numbers: 00061194, 1R03HD4453401A2
Study First Received: August 24, 2006
Last Updated: February 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Rehabilitation
Physical Therapy Techniques
Occupational Therapy
Upper Extremity; Motor skills

Additional relevant MeSH terms:
Hemiplegia
Cerebral Infarction
Stroke
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 12, 2012



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