This trial is looking to compare the effects of three different therapies on recovery of hand function after a stroke. The main outcome to be measured is the change in hand function. This study is being conducted in New Jersey and Ohio, the US.
The details
After a stroke, patients often experience muscle stiffness on one side of the body. Some patients even lose the ability to open the affected hand. This affects their daily activities and quality of life.
Contralaterally controlled functional electrical stimulation (CCFES) and cyclic neuromuscular electrical stimulation (CNES) are two recent therapies in the treatment of arm disability. CCFES uses a signal from the healthy side of the body to control the intensity of the electrical impulses delivered to the disabled side. In CNES the muscle (contracted) is repeatedly receiving electrical impulses to increase strength. Task oriented training (TOT) is another rehabilitation strategy that uses daily living tasks to guided by a therapist to train the weak hand.
This trial is evaluating CCFES, CNES, and TOT in patients who had a stroke. The main outcome will be measured by recording the changes in hand movement and function.
Who are they looking for?
This study is looking for 171 participants. Patients should have had a stroke within the last 6 to 24 months and is able to move the shoulder and elbow of their affected arm. The patients should show the ability to understand and follow instructions and should be able to open the other hand.
Participants should not be receiving occupational therapy, should not have any other brain condition or heart disease. Patients also should not have had treatment with botulinum toxin within the previous 3 months and should not be pregnant.
How will it work
Patients will be randomly assigned to receive 12 weeks of CCFES, CNES, and TOT.
The treatment includes 10 sessions per week of treatment at home plus 2 sessions per week of occupational therapy in the clinic. The follow-up will be done at 0, 12 and 36 weeks. The change in hand function will be measured by counting how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.
