NCT07202520

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: H'ability · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	IVR : H'Ability Home	H'Ability Home is a Dtx (Digital therapeutics) designed for the neurological rehabilitation of patients who have suffered a stroke, via a wireless virtual reality headset, with a simplified control interface on a tablet or PC
DEVICE	Control: paper-based exercise guide	self-rehabilitation booklet used in current practice in centers

Timeline

• Start date: 2025-10-30
• Primary completion: 2026-08-08
• Completion: 2026-09-29
• First posted: 2025-10-01
• Last updated: 2025-10-01

Locations

5 sites across 1 country: France