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

University of Calgary

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Rehabilitation Exercise Program; Device: Axem Home Prototype Device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05016193

REB20-1200

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Intervention Group

Experimental group

Description:

* Participants will attend 3 assessment sessions: one at the beginning of the study, one after about 3 weeks, and one at the end of the study. These sessions will be conducted by a trained physiotherapist. * Participants will be asked to wear the Axem Home prototype headband when doing their daily upper-extremity rehabilitation exercises at home. * Participants will perform a short motor assessment while wearing the Axem Home prototype headband once per week.

Treatment:

Device: Axem Home Prototype Device

Behavioral: Rehabilitation Exercise Program

Control Group

Active Comparator group

Description:

* Participants will attend 3 assessment sessions: one at the beginning of the study, one after about 3 weeks, and one at the end of the study. These sessions will be conducted by a trained physiotherapist. * Participants will be asked to keep track of how many minutes of rehabilitation they have completed as per standard care. * Participants will perform a short motor assessment while wearing the Axem Home prototype headband once at the beginning of the study and again at the end of the study during the clinical assessment sessions.

Treatment:

Behavioral: Rehabilitation Exercise Program