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

NCT ID: NCT06892886

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Sub-acute Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

VR group

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

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

Four tasks, uni and bi-manuals, will be proposed for the treatment of the patient's paretic upper limb in virtual-apartment for improving the relevance and the transferability of the movements requested.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality

Four tasks, uni and bi-manuals, will be proposed for the treatment of the patient's paretic upper limb in virtual-apartment for improving the relevance and the transferability of the movements requested.

Intervention Type: DEVICE

Other Intervention Names

Head-mounted display

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale Accreditato Villa Bellombra

UNKNOWN

Sponsor Role: collaborator

Casa di Cura Città di Rovigo

UNKNOWN

Sponsor Role: collaborator

IRCCS Centro Neurolesi Bonino Pulejo

OTHER

Sponsor Role: collaborator

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ferrara University Hospital

Ferrara, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Sofia Straudi, MD, PhD

Role: CONTACT

sofia.straudi@unife.it

+390532238720

Facility Contacts

Sofia Straudi, MD, PhD

Role: primary

sofia.straudi@unife.it

0532238720

Other Identifiers

VR_STROKE_MULTICENTER

Identifier Type: -

Identifier Source: org_study_id