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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2024-08-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

* 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.

Group Type EXPERIMENTAL

Axem Home Prototype Device

Intervention Type DEVICE

The Axem Home prototype device is a rehabilitation system designed to be used independently by a stroke survivor to facilitate physical rehabilitation exercises in their home environment. The device uses a functional near-infrared spectroscopy (fNIRS) headband that measures the hemodynamic response to rehabilitation exercises and displays this brain activity information to the user.

Rehabilitation Exercise Program

Intervention Type BEHAVIORAL

Individual exercise program prescribed by a therapist in the Early Supported Discharge Program.

Control Group

* 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.

Group Type ACTIVE_COMPARATOR

Rehabilitation Exercise Program

Intervention Type BEHAVIORAL

Individual exercise program prescribed by a therapist in the Early Supported Discharge Program.

Interventions

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Axem Home Prototype Device

The Axem Home prototype device is a rehabilitation system designed to be used independently by a stroke survivor to facilitate physical rehabilitation exercises in their home environment. The device uses a functional near-infrared spectroscopy (fNIRS) headband that measures the hemodynamic response to rehabilitation exercises and displays this brain activity information to the user.

Intervention Type DEVICE

Rehabilitation Exercise Program

Individual exercise program prescribed by a therapist in the Early Supported Discharge Program.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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