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Completed

NCT Number: NCT00369668

Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments

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.

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Key information

Age range

44 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Motor Behavior Laboratory, University of Florida

Gainesville, Florida, 32611, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilateral movements and neuromuscular electrical stimulation

Behavioral

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 names: functional electrical stimulation

Bilateral movements and sham electrical stimulation

Behavioral

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 names: functional electrical stimulation - sham

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 29, 2006
Registry last updated
Jun 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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