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StrokeNCT05016193

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

A study testing Axem Home Prototype Device and Rehabilitation Exercise Program in people with Stroke, run by University of Calgary at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Stroke
What is being tested?
Axem Home Prototype Device and Rehabilitation Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
1 Aug 2021to 9 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Have open wounds on their scalp

Who cannot join

  • Score ≥15 on the PHQ-9
  • Score <10 on the MoCA or <20 on the CASP

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Calgary Stroke Program Early Supported Discharge

    Calgary, Alberta, T2N 4N1

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Stroke
Being tested
Axem Home Prototype Device, Rehabilitation Exercise Program
Keywords
Rehabilitation, Neurofeedback, Functional near-infrared spectroscopy, Neuroergonomics, Motor cortex, Gamification
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Axem Home Prototype DeviceDevice

    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 ProgramBehavioural

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

Study groups in NCT05016193
Study groupRoleWhat they receive
Intervention GroupExperimental* 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.
Receives: Device: Axem Home Prototype Device; Behavioral: Rehabilitation Exercise Program
Control GroupActive 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.
Receives: Behavioral: Rehabilitation Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. Participation

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

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

Secondary outcomes (20)
  1. 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.

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

  2. 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).

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

  3. 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.

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

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: Baseline

  6. 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.

    Measured: Baseline

  7. 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.

    Measured: Baseline

  8. 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).

    Measured: Baseline

  9. Clinician Assessment of Vision

    Vision will be screened at study entry by clinician observation to assess visual fields for the presence of visual neglect.

    Measured: Baseline

  10. 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.

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

  11. Modified Rankin Scale (mRS)

    A disability rating scale from 0 (no symptoms at all) to 6 (deceased).

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

  12. Thumb Localizing Test

    A standardized assessment of proprioception. Scores range from 1 (no difficulty) to 3 (severe difficulty), with lower scores indicating better function.

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

  13. 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).

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

  14. 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.

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

  15. Functional Near-Infrared Spectroscopy (fNIRS) Measures

    Brain activity feedback from the motor cortex measured during rehabilitation exercises.

    Measured: 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)

  16. Recording of Assigned Home Exercises

    Recording of the specific homework exercises assigned by the therapist that the participant completes throughout the week.

    Measured: Weekly (for an average of 6 weeks)

  17. Home Exercise Compliance

    Proportion of a given participant's weekly assigned home exercise volume (in minutes) they complete.

    Measured: Weekly (for an average of 6 weeks)

  18. 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.

    Measured: Intervention group only: rehabilitation sessions (for an average of 6 weeks)

  19. 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.

    Measured: Images taken from within the first week after stroke; collected during the baseline assessment

  20. 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.

    Measured: Images taken from within the first week after stroke; collected during the baseline assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2021
  2. Study start1 Aug 2021
  3. Primary completion1 Aug 2024
  4. Study completion9 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05016193
Sponsor's protocol ID
REB20-1200
Status last verified
Aug 2021
First submitted
8 Feb 2021
Last updated
13 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 23404723

Questions about this trial

What is this clinical trial studying?

A study testing Axem Home Prototype Device and Rehabilitation Exercise Program in people with Stroke, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events Related to the Axem Home Prototype Device (Safety and Tolerability) (time frame: Intervention group only: through study completion, an average of 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05016193, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.

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