After a stroke, it is very common to lose the ability to open the affected hand. The purpose of this study is to compare the effects of three different therapies on recovery of hand function after stroke and determine if any one is better than the other.
A single-blinded randomized controlled trial will be carried out to assess and compare the effects of 12 weeks of Contralaterally Controlled Functional Electrical Stimulation (CCFES), Cyclic Neuromuscular Electrical Stimulation (cNMES), and Task Oriented Training. Dexterity, upper limb impairment, and activity limitation will be assessed at 0 (baseline), 12 (end of treatment), and 36 weeks. The treatment dose will be the same for all three groups: 10 sessions per week of self-administered treatment at home plus 2 sessions per week of group-specific occupational therapy in the lab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
132
An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
Emory University and Atlanta VA
Atlanta, Georgia, United States
Johns Hopkins University
Baltimore, Maryland, United States
Kessler Foundation
West Orange, New Jersey, United States
MetroHealth Rehabilitation Institute
Cleveland, Ohio, United States
Change in Box and Blocks Test (BBT) at 6 Months Post-Treatment
The BBT is a measure of hand dexterity. It is a count of how many blocks a patient can pick up, move over a barrier, and release in 60 seconds. The higher the score, the better the motor recovery.
Time frame: Baseline to 6 months post-treatment
Change in Upper Extremity Fugl Meyer (UEFM) at 6 Months Post-Treatment
The UEFM is a measure of upper limb motor impairment with a minimum score of 0 and maximum score of 66. The higher the score, the better the motor recovery.
Time frame: Baseline to 6 months post-treatment
Change in Action Research Arm Test (ARAT) at 6 Months Post-Treatment
The ARAT is a measure of arm and hand function with a minimum score of 0 and maximum score of 57. The higher the score, the better the motor recovery.
Time frame: Baseline to 6 months post-treatment
Change in Stroke Upper Limb Capacity Scale (SULCS) at 6 Months Post-Treatment
The SULCS is a measure of upper limb capacity with a minimum score of 0 and maximum score of 10. The higher the score, the better the motor recovery.
Time frame: Baseline to 6 months post-treatment
Responder Rate
Proportion of participants who had a gain of at least 6 points on the UEFM
Time frame: Baseline to 6 months post-treatment
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