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

NCT06892886 | Recruiting

• 1 other identifier: VR_STROKE_MULTICENTER
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

stroke; rehabilitation; upper limb; immersive virtual reality; head-mounted display; subacute stroke

Outcome Measures

Primary Outcomes (1)

• Changes in upper limb impairment

  Motor recovery will be assessed through the Fugl Meyer Assessment - Upper Extremity

  Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)

Secondary Outcomes (8)

• Change in Spasticity

  Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)

• Change in Activities of Daily Living

  Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)

• Change in perceived quality of life

  Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)

• Kinematic data

  Parameters changes (e.g. hand peak velocities) before (T0) and after (T1) the 4 weeks of treatment

• Electroencephalogram

  Data changes before (T0) and after (T1) the 4 weeks of treatment (4 weeks) and at 6-month follow-up (T2)

Study Arms (2)

VR group

EXPERIMENTAL

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

Device: Virtual Reality

Control group

NO INTERVENTION

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

Interventions

Virtual Reality 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.

Also known as: Head-mounted display

VR group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Ferrara: lead
• Ospedale Accreditato Villa Bellombra: collaborator
• Casa di Cura Città di Rovigo: collaborator
• IRCCS Centro Neurolesi Bonino Pulejo: collaborator

Study Sites (1)

Ferrara University Hospital

Ferrara, 44124, Italy

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Smart Glasses

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

Sofia Straudi, MD, PhD

CONTACT

+390532238720; sofia.straudi@unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization scheme will be generated using the website http://www.randomization.com and managed by an external administrator. The clinicians who will perform the outcome assessment will be blind regarding the subject's group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: March 25, 2025
• Study Start: March 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 25, 2025

Record last verified: 2024-11

Locations

IT (1)