This phase 3 trial is examining the effectiveness and safety of a virtual reality therapy in the treatment of patients with impaired arm movements after a stroke. The main outcome to be measured is an improvement of arm function and in the quality of life of these patients.
This study is taking place in California, US.
The details
Arm disability is the most common complication after a stroke. This affects the ability to perform daily tasks and therefore the quality of life of these patients. Virtual reality has been shown to help in the rehabilitation of the affected arm. The Smart Glove consists of a glove-shaped sensor device and a software application which can be used with a screen (or a tablet). The system includes training games for arm rehabilitation that can be done without supervision.
This trial is testing the safety and effectiveness of the Smart Glove device in patients with arm movement impairment after a stroke. The main outcome to be measured is the improvement in the functional movement of the arm.
Who are they looking for?
This trial is recruiting 40 patients with stroke and arm disability. Patients must have had a stroke diagnosis within 30 days prior to the start of this trial. Must be able to play 2 out of 4 test games with the Smart Glove.
Patients must not have a psychological or brain disorder, severe pain or any other condition that can limit the treatment.
How will it work
There will be 2 groups for this study. Patients will be randomly assigned to start standard rehabilitation therapy with and without the use of the Smart Glove. The treatment will last for 12 weeks with a follow-up period of another 12 weeks. Patients in the Smart Glove group will receive the device (the glove and a tablet). The treatment consists of using the glove for at least one session per day for 5 days per week for 12 weeks. The follow-up visits will be at weeks 6, 12 and 24.
The outcomes will be measured by the change in arm function between the start and end of the treatment.
