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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Axem Home Prototype Device; Behavioral: Rehabilitation Exercise Program

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • Calgary Stroke Program Early Supported Discharge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Behavioral: Rehabilitation Exercise Program; Individual exercise program prescribed by a therapist in the Early Supported Discharge Program.
Active Comparator: 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.	Behavioral: Rehabilitation Exercise Program; Individual exercise program prescribed by a therapist in the Early Supported Discharge Program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fugl-Meyer Assessment (FMA) of Motor Recovery	A stroke-specific, performance-based impairment index. The FMA is designed to assess motor functioning, sensation, balance, joint range of motion and joint pain in patients with post-stroke hemiplegia. Sub-scales include: upper extremity (0-36), wrist (0-10), hand (0-14), coordination/speed (0-6) (which can be combined to form a total motor function score out of 66), and sensation (0-4). Higher scores indicate better performance.	Baseline, week 3, and post-intervention (after study completion, an average of week 6)
Change in Action Research Arm Test (ARAT) score	The ARAT assesses arm function to determine the quality of the arm movement, and the limitation of activity. The ARAT consists of 4 sub-tests; that examines and individual's grip, grasp, pinch and gross motor movement in order to determine upper extremity function. Objects of varying size, shape, and weight must be either grasped, handled or moved in a specific task in order to evaluate function. Low scores mean worse function with the minimum possible score being 0 and the highest possible score being 57 (normal function).	Baseline, week 3, and post-intervention (after study completion, an average of week 6)
Stroke Impact Scale (SIS)	Stroke-specific, self-report, health status measure. Assesses multiple domains on a 5-point Likert scale. Domains include: strength (4-20), hand function (5-25), activities of daily living/instrumental activities of daily living (10-50), mobility (9-45), communication (7-35), emotion (9-45), memory and thinking (7-35), and participation (8-40). An extra question asks that the patient rate on a scale from 0 - 100 how much they feel that he/she has recovered from his/her stroke. The 4 physical domains (strength, hand function, mobility and activities of daily living) can be summed together to create a single, physical dimension score (28-140) while all other domains should remain separate. Higher scores indicate better function.	Baseline, week 3, and post-intervention (after study completion, an average of week 6)
National Institutes of Health Stroke Scale (NIHSS)	A 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Higher scores indicate greater impairment.	Baseline
Cognitive Assessment for Stroke Patients (CASP)	A questionnaire designed to measure cognitive function in patients regardless of the presence of aphasia, with lower scores indicating greater impairment.	Baseline
Patient Health Questionnaire (PHQ-9)	A major depressive disorder sub-scale of the full PHQ; used to provisionally grade depressive symptoms in patients. Higher scores indicate the presence of more severe depression.	Baseline
Montreal Cognitive Assessment (MoCA)	A cognitive screening test used to assess: short term memory, visuospatial abilities, executive functions, attention, concentration, working memory, language, and orientation to time and place. Higher scores indicate better function.	Baseline
Snellen Eye Chart Assessment of Visual Acuity	Vision will be screened at study entry using a Snellen Eye chart, with acuity ranging from 20/20 (higher acuity) to 20/200 (lower acuity).	Baseline
Clinician Assessment of Vision	Vision will be screened at study entry by clinician observation to assess visual fields for the presence of visual neglect.	Baseline
Functional Independence Measure (FIM)	The FIM rates subjects on 18 items across many functions such as eating, grooming, bathing and dressing on a scale from 1 (total assistance needed) to 7 (complete independence). Lowest possible score is 18 (lowest independence) and the best possible score is 126 (completely independent). The FIM is the standard measure used by rehabilitation facilities in Canada and the United States to evaluate overall function and burden of care.	Baseline and post-intervention (after study completion, an average of week 6)
Modified Rankin Scale (mRS)	A disability rating scale from 0 (no symptoms at all) to 6 (deceased).	Baseline and post-intervention (after study completion, an average of week 6)
Thumb Localizing Test	A standardized assessment of proprioception. Scores range from 1 (no difficulty) to 3 (severe difficulty), with lower scores indicating better function.	Baseline and post-intervention (after study completion, an average of week 6)
Strength	Strength will be assessed using the Medical Research Council scale for muscles in the upper extremity. Scores range from 0 (no movement observed) to 5 (muscle contracts normally against full resistance).	Baseline and post-intervention (after study completion, an average of week 6)
Modified Ashworth Scale (MAS)	A strength scale used to assess muscle tone during flexion and extension. Scores range from 0 (no increase in tone) to 4 (affected part(s) rigid in flexion or extension), with lower scores indicating better function.	Baseline and post-intervention (after study completion, an average of week 6)
Functional Near-Infrared Spectroscopy (fNIRS) Measures	Brain activity feedback from the motor cortex measured during rehabilitation exercises.	Intervention group: baseline, once per week for an average of 6 weeks, and post-intervention (after study completion, an average of week 6). Control group: baseline and post-intervention (after study completion, an average of week 6)
Recording of Assigned Home Exercises	Recording of the specific homework exercises assigned by the therapist that the participant completes throughout the week.	Weekly (for an average of 6 weeks)
Home Exercise Compliance	Proportion of a given participant's weekly assigned home exercise volume (in minutes) they complete.	Weekly (for an average of 6 weeks)
Video Capture	This data will be used to confirm that the Axem Home prototype device has been correctly placed and securely fitted on the head, which is an assumption of the analysis of functional near-infrared spectroscopy (fNIRS) measures.	Intervention group only: rehabilitation sessions (for an average of 6 weeks)
Magnetic Resonance Imaging (MRI)	Structural images taken from within the first week after stroke (if available). These images will be used to document lesion location and size, and to provide underlying information about functional connections between brain structures.	Images taken from within the first week after stroke; collected during the baseline assessment
Computed Tomography Scan Imaging (CT)	Structural images taken from within the first week after stroke (if available). These images will be used to document lesion location and size, and to provide underlying information about functional connections between brain structures.	Images taken from within the first week after stroke; collected during the baseline assessment

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Axem Neurotechnology Inc.
• Investigators: Principal Investigator: Sean Dukelow, MD PhD FRCPC, University Of Calgary

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): August 9, 2024

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Neurofeedback; Gamification; Functional near-infrared spectroscopy; Motor cortex; Neuroergonomics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: REB20-1200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No