Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments

University of Florida

Status and phase: Completed; Phase 2

Conditions: Cerebrovascular Accident; Hemiplegia

Treatments: Behavioral: Bilateral movements and neuromuscular electrical stimulation; Behavioral: Bilateral movements and sham electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00369668

00061194

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 44 to 86 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

High Intensity

Experimental group

Description:

Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.

Treatment:

Behavioral: Bilateral movements and neuromuscular electrical stimulation

Behavioral: Bilateral movements and neuromuscular electrical stimulation

Low Intensity

Active Comparator group

Description:

Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.

Treatment:

Behavioral: Bilateral movements and neuromuscular electrical stimulation

Behavioral: Bilateral movements and neuromuscular electrical stimulation

Control

Active Comparator group

Description:

Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation

Treatment:

Behavioral: Bilateral movements and sham electrical stimulation