Independent Use of Brain Measurement-Based Rehabilitation System by Stroke Survivors

Independent Use of Brain Measurement-Based Rehabilitation System by Stroke Survivors: A Randomized Open Label Phase 1 Clinical Trial With Blinded Evaluation

The Axem Home study is a randomized open label trial analyzing the safety and feasibility of coupling the Axem Home prototype device with exercise to improve motor recovery following a stroke.

The Axem Home study is a randomized, open label, phase I clinical trial evaluating the safety and feasibility of coupling feedback to participants on their levels of sensorimotor brain activity (via the Axem Home prototype device) with exercise rehabilitation. 15 participants will be enrolled in each arm of the study. Both groups will participate in an exercise program, but only one group (the intervention group) will receive the Axem Home prototype device.

Study participants will be evaluated at baseline, after 3 weeks, and after 6 weeks (upon the completion of their time in the Early Supported Discharge program). Evaluators will be blinded as to which group participants are in. The study is constructed with randomization to remove selection and allocation biases.

Inclusion Criteria:

• Accepted into the Calgary Stroke Program's Early Supported Discharge program for stroke survivors
• Aged 18 or older
• Visual acuity better than 20/50 in both eyes
• Able to give consent
• Clinician reported upper-extremity movement deficit

Exclusion Criteria:

• Score ≥15 on the PHQ-9
• Score <10 on the MoCA or <20 on the CASP
• Inclusion in another interventional trial
• Have open wounds on their scalp