Posted by on Mar 12, 2019 in Stroke | 0 comments

In a nutshell

This trial is examining the effectiveness of home-based telerehabilitation with Bilateral Arm Training with Rhythmic Auditory Cueing (BATRAC). The main outcome to be measured is time and quality of movement and the ability to hold a weight. This trial is recruiting in Baltimore, Maryland, United States.

The details

Patients with stroke often experience loss of strength and stiffness in the arms. This affects the quality of life of the patients and their caregivers. The use of robot-assisted treatment plans has shown to improve movement. However, this type of therapy cannot be done at home as these devices are large and expensive.

BATRAC is a non-robotic training device that can be used at home. This therapy forces the reaching actions using the sound of a metronome (a device used by musicians that gives a regular ticking sound). The use of telerehabilitation (guided training through a communication device such as a computer) allows the patient to perform this at home.

The main outcomes will be assessed using a movement function test that measures the movement quality and speed.

Who are they looking for?

78 patients are needed for this trial. Participants should have had a stroke at least 6 months prior to the start of this trial. They should present a moderate to severe arm disability and ability to work with a communication device such as a computer.

Patients should not have had previous BATRAC therapy. Patients should also not have significant arm pain, should not have had enrolled in another therapy study or received a botulinum toxin injection within the previous 3 months.  

How will it work

Participants will be randomly assigned to receive home-based BATRAC (group 1), clinic-based BATRAC (group 2) and delayed treatment (group 3). Patients from group 1 and 2 will receive treatment 3 times a week for 6 to 9 weeks for a total of 18 training sessions. The last follow-up visit will be after 8 weeks of no training.  

Patients in group 1 will be given an online platform (to be used in a computer with internet connection) for communicating with the assigned therapist. Training will consist of 45 minutes of high-intensity arm exercises and rest periods followed by 15 minutes of video guided transition to task training (TTT). TTT uses daily tasks as training exercises for arm rehabilitation. The patients will then complete a session report that will be assessed by the therapist.

Patients in group 2 will receive 60 minutes of training in the clinic (45 min of BATRAC and 15 of TTT).

Patients from group 3 will not receive any treatment while the other two groups are. This group will then receive delayed treatment by either clinic-based BATRAC plus TTT or clinic-based robot TTT.  

Clinical trial locations

Locations near 20147, United States (Change):
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Study ID:NCT02665052
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