NCT07202520尚未招募不适用
Evaluation of the Benefit of the H'Ability Home Device Used in Supervised Self-rehabilitation at Home on the Autonomy of Post-stroke Patients
H'ability10 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年10月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 10
- 主要终点
- To evaluate the impact of the H'Ability Home device on the level of autonomy of post-stroke patients compared to the exercise booklet.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke diagnosis: first stroke, with no history of stroke, documented in the medical record
- •Currently in rehabilitation (in a center) (full hospitalization or day hospitalization for at least 3 days/week) for another 2 to 4 weeks.
- •Planned return home (home self-rehabilitation phase): Patients at the end of their rehabilitation stay and scheduled to return home where the self-rehabilitation phase can take place.
- •Ability to use virtual reality: Physical and cognitive ability to interact with virtual reality devices, at the discretion of therapists.
- •Adult: Patients aged 18 years or older.
- •Informed consent: Voluntary agreement to participate in the study after a full explanation of its terms and conditions.
- •Member of a social security scheme or eligible beneficiary
- •Distance between home and center included within the usual perimeter of each site.
- •Presence of a third-party family caregiver at home who has agreed to ensure the patient's safety during self-rehabilitation sessions with the H'Ability Home device (consent)
- •Availability of a Wi-Fi network and internet access at the patient's home
- •Presence of an adequate space at home to perform rehabilitation exercises
- •Person with low to reasonable sensitivity to motion sickness (MSSQ ≤ 15)
- •Patient non inclusion Criteria:
- •• Visual disorders incompatible with the use of virtual reality (absence of binocular vision, blindness, conjunctivitis, etc.) at the discretion of the investigator. PS: Visual disorders corrected by wearing a vision correction device are not concerned because glasses or contact lenses can be worn when using an IVR headset.
- •Major cognitive impairment: Severe cognitive impairment affecting the patient's ability to understand or follow study instructions, or to operate the device independently, at the investigators' discretion.
- •History of epilepsy: History of epileptic seizures, particularly photosensitive seizures, which may be triggered or aggravated by the use of virtual reality.
- •Medical instability: presence of unstable or uncontrolled medical conditions that could interfere with active participation in rehabilitation.
- •Psychiatric illnesses: active psychiatric disorders (e.g., psychosis, unstabilized bipolar disorder) that could disrupt participation and continuity of rehabilitation, at the investigators' discretion.
- •Wearing implantable medical devices or personal medical devices that could be affected by radio waves (pacemakers, cochlear implants, etc.)
- •Participation in another clinical study: engagement in another clinical study likely to interfere with the study objectives or outcome assessments
- •Planned hospitalization during the home self-rehabilitation period
- •Pregnant, childbirth, or breastfeeding women
- •Persons deprived of their liberty by a judicial (including guardianship, curatorship, and judicial protection) or administrative decision
- •Persons receiving psychiatric care or admitted to a health or social care facility for purposes other than research
- •Persons in an emergency situation unable to express their prior consent
- •Third-party family caregiver Inclusion Criteria:
- •Adult: Person aged 18 years or older
- •Informed consent: Voluntary agreement to participate in the study after a full explanation of its terms and conditions.
- •Member of a social security scheme or entitled person
- •Patient's family caregiver
- •Ability to assist the patient in using the device
- •Ability to ensure the patient's safety when using the device
- •Agreement to assist and ensure the patient's safety when using the device at home
- •Agreement to provide feedback on the device by completing self-administered questionnaires (UTAUT) - optional
- •Third-party family caregiver non-inclusion Criteria:
- •Pregnant, childbirth, or breastfeeding women
- •Persons deprived of their liberty by a judicial (including guardianship, curatorship, and judicial protection) or administrative decision
- •Persons receiving psychiatric care or admitted to a health or social care facility for purposes other than research
- •Persons in an emergency situation unable to express their prior consent
排除标准
- 未提供
结局指标
主要结局
To evaluate the impact of the H'Ability Home device on the level of autonomy of post-stroke patients compared to the exercise booklet.
时间窗: T0 (screening), T1(Baseline), T2(week 6), T3(week 7), T4 (week 13)
Level of autonomy by the functional independence measure (FIM) score. From 18 (no autonomy) to 126 (full autonomy).
次要结局
- To evaluate the effect of the H'Ability Home device on the cognitive abilities of post-stroke patients compared to the exercise booklet.(T1(Baseline), T2(week 6), T3(week 7), T4 (week 13))
- Describe patient compliance with both devices: H'Ability Home and exercise booklet.(T2(week 6), T4 (week 13))
- Describe the level of mental load of patients with the two devices: H'Ability Home and exercise booklet(T2(week 6), T4 (week 13))
- Describe the level of motion sickness associated with the use of the H'Ability Home virtual reality device(T2(week 6), T4 (week 13))
- Evaluate the impact of the H'Ability Home device on satisfaction with rehabilitation exercises in post-stroke patients compared to the exercise booklet.(T2(week 6), T4 (week 13))
- To evaluate the impact of the H'Ability Home device on the walking speed of post-stroke patients compared to the exercise booklet.(T0 (screening), T1(Baseline), T2(week 6), T3(week 7), T4 (week 13))
- To evaluate the impact of the H'Ability Home device on the quality of life of post-stroke patients compared to the exercise booklet.(T1(Baseline), T2(week 6), T3(week 7), T4 (week 13))
- Evaluate the acceptability of the H'Ability Home device among patients and caregivers before use (a priori acceptability) and after use (a posteriori acceptability)(T0 (screening), T2(week 6), T4 (week 13))
- To evaluate the impact of the H'Ability Home device on the coordination of post-stroke patients compared to the exercise booklet.(T0 (screening), T1(Baseline), T2(week 6), T3(week 7), T4 (week 13))
- Evaluate the impact of the H'Ability Home device on the fear of falling in relation to the exercise booklet.(T1(Baseline), T2(week 6), T3(week 7), T4 (week 13))
研究者
研究点 (10)
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