Clinical trial NCT00565045: Treatments for Recovery of Hand Function in Acute Stroke Survivors
Official title: Contralaterally Controlled Functional Electrical Stimulation for Hemiparetic Hand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke, Acute
Stroke
Hemiparesis
Hemiplegia
Keywords: hand
stroke
hemiplegia
electrical stimulation
recovery
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: National Institutes of Health (NIH)
First posted: 2007-11-29
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment)
timeFrame: 3 months post-treatment.
Secondary outcomes:
measure: Finger Tracking Error
timeFrame: 3 months post-treatment.
measure: Box and Blocks Score
timeFrame: 3 months post-treatment.
measure: Arm Motor Abilities Test
timeFrame: 3 months post-treatment.
measure: Fugl-Meyer Assessment (Upper Extremity)
timeFrame: 3 months post-treatment.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: Jayme S Knutson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Knutson JS, Harley MY, Hisel TZ, Chae J. Improving hand function in stroke survivors: a pilot study of contralaterally controlled functional electric stimulation in chronic hemiplegia. Arch Phys Med Rehabil. 2007 Apr;88(4):513-20. doi: 10.1016/j.apmr.2007.01.003.
citation: Glanz M, Klawansky S, Stason W, Berkey C, Chalmers TC. Functional electrostimulation in poststroke rehabilitation: a meta-analysis of the randomized controlled trials. Arch Phys Med Rehabil. 1996 Jun;77(6):549-53. doi: 10.1016/s0003-9993(96)90293-2.
citation: Chae J, Bethoux F, Bohine T, Dobos L, Davis T, Friedl A. Neuromuscular stimulation for upper extremity motor and functional recovery in acute hemiplegia. Stroke. 1998 May;29(5):975-9. doi: 10.1161/01.str.29.5.975.
citation: Luft AR, McCombe-Waller S, Whitall J, Forrester LW, Macko R, Sorkin JD, Schulz JB, Goldberg AP, Hanley DF. Repetitive bilateral arm training and motor cortex activation in chronic stroke: a randomized controlled trial. JAMA. 2004 Oct 20;292(15):1853-61. doi: 10.1001/jama.292.15.1853.
citation: Whitall J, McCombe Waller S, Silver KH, Macko RF. Repetitive bilateral arm training with rhythmic auditory cueing improves motor function in chronic hemiparetic stroke. Stroke. 2000 Oct;31(10):2390-5. doi: 10.1161/01.str.31.10.2390.
citation: Mudie MH, Matyas TA. Can simultaneous bilateral movement involve the undamaged hemisphere in reconstruction of neural networks damaged by stroke? Disabil Rehabil. 2000 Jan 10-20;22(1-2):23-37. doi: 10.1080/096382800297097.