This trial is examining the effectiveness of a home-based device called myoelectric-computer interface (MCI), in the treatment of arm disability in patients with stroke. The main outcome will be the change in arm movement before and after the treatment. This trial will be conducted in Illinois, US.
The details
Stroke is a leading cause of death in the US. Often patients with stroke are left with complications such as arm disability. These patients are incapable of performing daily activities, affecting their quality of life. Some of these patients even have difficulties in performing activities outside of their homes.
Impaired arm movement is caused not just by weakness, but also impaired muscle activity. MCI helps to control the unwanted muscle activity improving recovery.
This trial is evaluating the effectiveness of a home-based wearable MCI device on the recovery of these patients. The main outcome will be assessed by measuring the change in arm movement before and after the treatment.
Who are they looking for?
This trial will be recruiting 96 patients with stroke and arm disability. Patients should have at least some movement in the shoulder and elbow of the affected arm. Patients should be able to understand and follow instructions and should have a full view of the screen.
Patients should not be participating in another study on the affected arm or severe arm pain. Patients should not be receiving another muscle treatment, such as Botox or any other agent.
How will it work
Patients will be divided into a chronic stroke group (patients who had a stroke within the last 6 months) or acute stroke group (patients who had a stroke within the last 7 days). Patients in the chronic group will work with 2 or 3 muscles at a time with MCI or by reaching to objects with MCI. Patients in the acute group will also receive treatment with MCI. Some patients in both groups will receive placebo (treatment with no effect in the body). Patients will be followed up for up to 10 weeks to assess muscle activity.
