Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00369668
First received: August 24, 2006
Last updated: June 12, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Cerebrovascular Accident
Hemiplegia
Behavioral: Bilateral movements and neuromuscular electrical stimulation
Behavioral: Bilateral movements and sham electrical stimulation
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Box and Block Test; Data Collected = Number of Blocks Moved [ Time Frame: Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: August 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Intensity
Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
Behavioral: Bilateral movements and 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 movements. Training period was 4 times per week for 2 weeks.
Other Name: functional electrical stimulation
Active Comparator: Low Intensity
Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
Behavioral: Bilateral movements and neuromuscular electrical stimulation
Participants 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 contracting muscles is provided to the paretic arm during the movements. Training period was 2 times per week for 2 weeks.
Other Name: functional electrical stimulation
Active Comparator: Control
Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation
Behavioral: Bilateral movements and sham electrical stimulation
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. Training period was 2 times per week for 2 weeks.
Other Name: functional electrical stimulation - sham

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).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369668

Locations
United States, Florida
Motor Behavior Laboratory, University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: James H. Cauraugh, Ph.D. University of Florida
  More Information

Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00369668     History of Changes
Other Study ID Numbers: 00061194
Study First Received: August 24, 2006
Results First Received: August 10, 2011
Last Updated: June 12, 2012
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:
Cerebral Infarction
Stroke
Hemiplegia
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014