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

NCT05016193 | Completed

• 1 other identifier: REB20-1200
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Rehabilitation; Neurofeedback; Functional near-infrared spectroscopy; Neuroergonomics; Motor cortex; Gamification

Outcome Measures

Primary Outcomes (4)

• Incidence of Adverse Events Related to the Axem Home Prototype Device (Safety and Tolerability)

  The ability of participants in the intervention group to complete the study using the Axem Home prototype device without experiencing an adverse event.

  Intervention group only: through study completion, an average of 6 weeks

• Usability Interview

  A short, semi-structured interview asking participants in the intervention group for qualitative assessments of various aspects of the Axem Home prototype device software and headband, in order to ascertain any potential areas where either might need to be improved.

  Intervention group only: once per week for an average of 6 weeks and post-intervention (after study completion, an average of week 6)

• Usability Questionnaire

  A short questionnaire asking participants in the intervention group to rate various aspects of the Axem Home prototype device with respect to its usability and perceived usefulness.

  Intervention group only: post-intervention (after study completion, an average of week 6)

• Participation

  The number of participants in the intervention group that choose to discontinue participation in the study without experiencing an adverse event.

  Intervention group only: through study completion, an average of 6 weeks

Secondary Outcomes (20)

• Change in Fugl-Meyer Assessment (FMA) of Motor Recovery

  Baseline, week 3, and post-intervention (after study completion, an average of week 6)

• Change in Action Research Arm Test (ARAT) score

  Baseline, week 3, and post-intervention (after study completion, an average of week 6)

• Stroke Impact Scale (SIS)

  Baseline, week 3, and post-intervention (after study completion, an average of week 6)

• National Institutes of Health Stroke Scale (NIHSS)

  Baseline

• Cognitive Assessment for Stroke Patients (CASP)

  Baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

* 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.

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

Control Group

ACTIVE COMPARATOR

* 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.

Behavioral: Rehabilitation Exercise Program

Interventions

Axem Home Prototype Device 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 Group

Rehabilitation Exercise Program BEHAVIORAL

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

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Score ≥15 on the PHQ-9
• Score \<10 on the MoCA or \<20 on the CASP
• Have open wounds on their scalp

Sponsors & Collaborators

• University of Calgary: lead
• Axem Neurotechnology Inc.: collaborator

Study Sites (1)

Calgary Stroke Program Early Supported Discharge

Calgary, Alberta, T2N 4N1, Canada

Location

Related Publications (1)

• Mihara M, Hattori N, Hatakenaka M, Yagura H, Kawano T, Hino T, Miyai I. Near-infrared spectroscopy-mediated neurofeedback enhances efficacy of motor imagery-based training in poststroke victims: a pilot study. Stroke. 2013 Apr;44(4):1091-8. doi: 10.1161/STROKEAHA.111.674507. Epub 2013 Feb 12.

  PMID: 23404723 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sean Dukelow, MD PhD FRCPC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: August 23, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 9, 2024
• Last Updated: August 13, 2024

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)