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Procedure

Axem Home Prototype Device for Stroke

N/A
Waitlist Available
Led By Sean Dukelow, MD PhD FRCPC
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights

Study Summary

This trial is testing a device that helps people with motor recovery following a stroke.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~images taken from within the first week after stroke; collected during the baseline assessment
This trial's timeline: 3 weeks for screening, Varies for treatment, and images taken from within the first week after stroke; collected during the baseline assessment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events Related to the Axem Home Prototype Device (Safety and Tolerability)
Participation
Usability Interview
+1 more
Secondary outcome measures
Change in Action Research Arm Test (ARAT) score
Change in Fugl-Meyer Assessment (FMA) of Motor Recovery
Clinician Assessment of Vision
+17 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment2 Interventions
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 II: Control GroupActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
792 Previous Clinical Trials
869,124 Total Patients Enrolled
33 Trials studying Stroke
40,305 Patients Enrolled for Stroke
Axem Neurotechnology Inc.Industry Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Sean Dukelow, MD PhD FRCPCPrincipal InvestigatorUniversity of Calgary
2 Previous Clinical Trials
420 Total Patients Enrolled
2 Trials studying Stroke
420 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Independent Use of Brain Measurement-Based Rehabilitation System by Stroke Survivors
2021. "Independent Use of Brain Measurement-Based Rehabilitation System by Stroke Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05016193.
~8 spots leftby Apr 2025
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