Treatments for Recovery of Hand Function in Acute Stroke Survivors

MetroHealth Medical Center

Status and phase: Completed; Phase 2; Phase 1

Conditions: Stroke; Stroke, Acute; Hemiparesis; Hemiplegia

Treatments: Device: Neuromuscular electrical stimulator

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00565045

R21HD054749

Details and patient eligibility

About

Impaired hand function is one of the most frequently persisting consequences of stroke. The purpose of this study is to investigate whether two different types of treatment improve recovery of hand function after stroke.

Full description

Loss of hand function is common after stroke. Previous research suggests that treatments that focus on movement of both hands at the same time or treatments that electrically stimulate the paretic (weak) hand muscles may help the recovery of hand function after stroke. In this study, two electrical stimulation treatments will be compared in their effectiveness in restoring hand movement and hand function. One of the treatments is stimulation only, and the other is stimulation linked to movement of the contralateral hand.

Study participants will be stroke survivors who are enrolled while they are still within their first 6 months after their stroke. After enrolling, their hand movement and function will be tested. Then they will be randomly assigned to one of the two treatments. Each treatment will last 6 weeks. The treatment will require the participant to perform specific exercises at home for a total of 2 hours every day and to come to the laboratory twice a week for study-related occupational therapy. At the end of the 6-week treatment, tests of hand movement and hand function will be repeated. The same tests will be repeated again at 1 and 3 months after the end of treatment to see if the effects of the treatment persist as time goes on. Changes in upper extremity impairment and activity limitation will be compared across treatment groups.

Enrollment: 21 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 to 80
• Within 6 months of first clinical hemorrhagic or nonhemorrhagic stroke
• Cortical or subcortical stroke
• Unilateral upper extremity hemiparesis with severe finger extensor and flexor paresis (<= grade 4 on Medical Research Council (MRC) scale)
• Adequate movement of the shoulder and elbow to allow volitional positioning of the affected hand in the workspace.
• Surface NMES of finger and thumb extensors produces functional hand opening without pain
• Full volitional opening of the contralateral hand of the unimpaired side.
• Able to follow 3 stage commands
• Able to remember at least 2 of 3 items after 30 minutes
• Able to hear and respond (by opening the less affected hand) to auditory cues issued from the stimulator?
• Caregiver available and willing to help assist with the device and home regimen and ensure compliance
• Skin intact on hemiparetic arm
• Medically stable

Exclusion criteria

• Insensate forearm and/or hand
• Edema of the affected forearm and/or hand
• History of potentially fatal cardiac arrhythmias.
• Cardiac pacemakers or any other implanted electronic systems
• Pregnant women
• Uncontrolled seizure disorder
• Severely impaired cognition or comprehension
• Uncompensated hemineglect
• Severe depression (>= 13 on Beck Depression Inventory Fast Screen)
• Ipsilateral lower motor neuron lesion
• Parkinson's Disease
• Spinal cord injury
• Traumatic brain injury
• Multiple sclerosis
• Lack of functional passive range of motion of the wrist or fingers of affected side
• Severe shoulder or hand pain (unable to volitionally position hand in the workspace without pain)
• Intramuscular botulinum toxin injections in upper extremity muscle in the last 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

CCFES

Experimental group

Description:

CCFES - Contralaterally Controlled Functional Electrical Stimulation * Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand * A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity * Therapy sessions are done with the subject being assisted by the CCFES system.

Treatment:

Device: Neuromuscular electrical stimulator

cNMES

Active Comparator group

Description:

cNMES - Cyclic NeuroMuscular Electrical Stimulation. * Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject. * Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation * Therapy sessions are done without the stimulation system

Treatment:

Device: Neuromuscular electrical stimulator