Treatments for Recovery of Hand Function in Acute Stroke Survivors

Completed · Phase 1/Phase 2

Conditions studied: Stroke, Acute, Stroke, Hemiparesis, Hemiplegia

In brief

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.

Key facts

Study ID

NCT00565045

Run by

MetroHealth Medical Center

People needed

21

Starts

2007-07-01

Expected to finish

2010-04-01

Last updated by the study team

2018-12-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MetroHealth Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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