Telerehabilitation Through Serious Games in Virtual Reality in a Stroke Population (AutoRReVi)

Stroke Clinical Trial

— AutoRReVi  

Official title:

Self-assessment and Telerehabilitation Using Virtual Reality Devices and Serious Games to Improve Motor and Cognitive Impairments in Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04694833
• Other study ID #: ROBIGAME
• Secondary ID: 1810108
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2020
• Est. completion date: October 15, 2022

Study information

• Verified date: June 2022
• Source: Université Catholique de Louvain
• Contact: Gauthier Everard, MSc, PT
• Phone: +32472500158
• Email: gauthier.everard[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 15, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Healthy Subjects
• Hemiparesis
• Paresis
• Stroke

Intervention

Behavioral:
• Motor and cognitive virtual reality-based assessments
Motor and cognitive testing in virtual reality
• Motor and cognitive virtual reality-based serious games
Serious games implemented in virtual reality to rehabilitate motor and cognitive impairments.

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels	Woluwé

Sponsors (2)

Lead Sponsor	Collaborator
Université Catholique de Louvain	Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper Extremity Fugl-Meyer Assessment	Highly recommended scale that assess upper limb motor function (0% = worse outcome; 100% best outcome).	Through study completion, on average 24 weeks
Primary	Box and Block Test	A measure of manual dexterity and activity that requires repeatedly moving 1-inch blocks from one side of a box to another in 60 seconds.	Through study completion, on average 24 weeks
Primary	The Bells Test	A cancellation task, permits a quantitative and qualitative evaluation of visual neglect	Through study completion, on average 24 weeks
Primary	Action Research Arm Test	A 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning). Items are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).	Through study completion, on average 24 weeks
Primary	System Usability Scale	Reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree	Through study completion, on average 24 weeks
Secondary	Upper limb 3D position	Upper limb 3D position will be measured with different virtual reality devices (Oculus Quest, htc Vive, REAtouch). This will be done thanks to the headset's infra-red camera or the controller's inertial measurement units.	Through study completion, on average 24 weeks
Secondary	Upper limb peak velocity	Upper limb peak velocity will be measured with different virtual reality devices (Oculus Quest, htc Vive, REAtouch). This will be done by deriving 3D position (obtained previously thanks to the headset's infra-red camera or the controller's inertial measurement units) and extracting highest value.	Through study completion, on average 24 weeks
Secondary	Upper limb smoothness	Upper limb smoothness will be measured with different virtual reality devices (Oculus Quest, htc Vive, REAtouch). This will be done by deriving three times 3D position (obtained previously thanks to the headset's infra-red camera or the controller's inertial measurement units) and converting it to a logarithmic dimensionless jerk. Second option is to measure a spectral arc length (also computed from 3D position)	Through study completion, on average 24 weeks