Using Immersive Virtual Reality for the Upper Limb Rehabilitation of Post-stroke Subjects

University Hospital of Ferrara

Status: Enrolling

Conditions: Sub-acute Stroke

Treatments: Device: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT06892886

VR_STROKE_MULTICENTER

Details and patient eligibility

About

Stroke produces brain damages that results in sensory, motor, and cognitive impairments which reduce the patient's quality of life and social participation. Upper limb recovery is a complex process whose goal is to allow the patients to gain, in part or completely, independence in daily living activities, for that it represents one of the most important rehabilitation focus. Virtual reality is a fairly recent approach able to simulate concrete movements and functional tasks in a higher dosage compared to other therapies. It seems that the use of VR could improve limb function, however, the amount of this gain is still unclear because of insufficient evidence. This study aims at quantitatively investigating the effectiveness of an HMD immersive virtual reality system on the upper limb functioning in subacute stroke survivors.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of first, ischemic or hemorrhagic, stroke verified by brain imaging within 4 week
• upper limb motor impairment defined by an upper extremity score <55 on the Fugl-Meyer Assessment

Exclusion criteria

• neurological conditions in addition to stroke that may affect motor function
• other medical conditions likely to interfere with the ability to safely complete the study protocol
• impaired cognitive functioning that influences the ability to give informed consent
• severe neuropsychological disorders
• visual impairment
• severe upper-limb pain defined as > 7 on the Visual Analogue Scale

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

VR group

Experimental group

Description:

All participants will receive an hour of VR training 5 times/week for 4 weeks within the daily rehab routine.

Treatment:

Device: Virtual Reality

Control group

No Intervention group

Description:

Participants will receive the usual rehabilitation activities due to their clinical needs (physical therapy, speech therapy, etc) for 5 times/week over 4 weeks.