Clinical trial NCT04694833: Telerehabilitation Through Serious Games in Virtual Reality in a Stroke Population (AutoRReVi)
Official title: Self-assessment and Telerehabilitation Using Virtual Reality Devices and Serious Games to Improve Motor and Cognitive Impairments in Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Hemiparesis
Cognitive Impairment
Healthy Subjects
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
First posted: 2021-01-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Studies will be conducted in a single group of (a) stroke patients and (b) healthy subjects
Primary purpose: TREATMENT

Brief summary: After a stroke, individuals present with motor and/or cognitive impairments. These impairments limit activity, restrict participation and affect quality of life. Therefore, rehabilitation programs are provided from the earliest days. However, an important proportion of patients do not achieve the recommended amount of rehabilitation therapy (even in institutional systems). In fact, patients do not always have access to healthcare systems. Moreover, hospital resources and healthcare systems are often limited (especially in poor countries) which has led to the development of new cost-effective rehabilitation methods such as self-rehabilitation and tele-rehabilitation.

This study aims :

1. to develop and validate relevant self-assessments tools in virtual reality
2. to propose auto-adaptative virtual reality-based therapies based on the link between motor and cognitive functions.


Eligibility criteria: Inclusion Criteria:

* Stroke patients (with hemiparesis or cognitive impairment such as apraxia, aphasia or hemineglect) OR healthy subjects
* Able to undersand simple instructions

Exclusion Criteria:

* Other disease that could affect upper limb motor function or cognition

Primary outcomes:
measure: Upper Extremity Fugl-Meyer Assessment
timeFrame: Through study completion, on average 24 weeks
measure: Box and Block Test
timeFrame: Through study completion, on average 24 weeks
measure: The Bells Test
timeFrame: Through study completion, on average 24 weeks
measure: Action Research Arm Test
timeFrame: Through study completion, on average 24 weeks
measure: System Usability Scale
timeFrame: Through study completion, on average 24 weeks
Secondary outcomes:
measure: Upper limb 3D position
timeFrame: Through study completion, on average 24 weeks
measure: Upper limb peak velocity
timeFrame: Through study completion, on average 24 weeks
measure: Upper limb smoothness
timeFrame: Through study completion, on average 24 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Woluwé
Study officials:
affiliation: Cliniques universitaires Saint-Luc - UCLouvain
name: Thierry Lejeune, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Everard G, Otmane-Tolba Y, Rosselli Z, Pellissier T, Ajana K, Dehem S, Auvinet E, Edwards MG, Lebleu J, Lejeune T. Concurrent validity of an immersive virtual reality version of the Box and Block Test to assess manual dexterity among patients with stroke. J Neuroeng Rehabil. 2022 Jan 22;19(1):7. doi: 10.1186/s12984-022-00981-0.