Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-01 @ 3:15 PM
Study NCT ID:
NCT05016193
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2021-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Independent Use of Brain Measurement-Based Rehabilitation System by Stroke Survivors
Sponsor:
University of Calgary
Organization:
Study Overview
Official Title:
Independent Use of Brain Measurement-Based Rehabilitation System by Stroke Survivors: A Randomized Open Label Phase 1 Clinical Trial With Blinded Evaluation
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: