Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT07202520
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Benefit of the H'Ability Home Device Used in Supervised Self-rehabilitation at Home on the Autonomy of Post-stroke Patients
Sponsor:
H'ability
Organization:
Study Overview
Official Title:
Evaluation of the Benefit of the H'Ability Home Device Used in Supervised Self-rehabilitation at Home on the Autonomy of Post-stroke Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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 goal of this clinical investigation is to evaluate the benefit of the H'Ability Home device used in supervised self-rehabilitation at home on the autonomy of post-stroke patients.
Participants will perform their self-rehabilitation exercises at home using a virtual reality headset incorporating H'Ability Home software for 6 weeks during the experimental phase. This phase will be compared to a 6-week control phase at home, with self-rehabilitation exercises presented in a paper format.
Participants will perform their self-rehabilitation exercises at home using a virtual reality headset incorporating H'Ability Home software for 6 weeks during the experimental phase. This phase will be compared to a 6-week control phase at home, with self-rehabilitation exercises presented in a paper format.
Detailed Description:
This is a prospective, multicenter, randomized, controlled, crossover, and repeated-measures clinical study.
Patients with a first stroke, currently undergoing rehabilitation in a center with a planned return home, and with low to reasonable susceptibility to motion sickness will be enrolled.
After inclusion, patients will be randomized to one of two study arms.
* Arm 1: Experimental phase / Washout / Control phase
* Arm 2: Control phase / Washout phase / Experimental phase
During the experimental phase, patients will perform their self-rehabilitation exercises at home using the H'Ability Home device for six weeks.
During the control phase, patients will perform their self-rehabilitation exercises at home using a paper-based exercise guide for six weeks. The two study phases are separated by a one-week washout period during which patients will not perform any self-rehabilitation exercises.
Patients with a first stroke, currently undergoing rehabilitation in a center with a planned return home, and with low to reasonable susceptibility to motion sickness will be enrolled.
After inclusion, patients will be randomized to one of two study arms.
* Arm 1: Experimental phase / Washout / Control phase
* Arm 2: Control phase / Washout phase / Experimental phase
During the experimental phase, patients will perform their self-rehabilitation exercises at home using the H'Ability Home device for six weeks.
During the control phase, patients will perform their self-rehabilitation exercises at home using a paper-based exercise guide for six weeks. The two study phases are separated by a one-week washout period during which patients will not perform any self-rehabilitation exercises.
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?: