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

Using Immersive Virtual Reality for the Upper Limb Rehabilitation of Post-stroke Subjects: a Multicenter Randomized Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Sub-acute Stroke
• Intervention / Treatment: Device: Virtual Reality

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sofia Straudi, MD, PhD; Phone Number: +390532238720; Email: sofia.straudi@unife.it

Study Locations

• Italy
  • Ferrara, Italy, 44124
    • Recruiting
    • Ferrara University Hospital
    • Principal Investigator: Sofia Straudi, MD, PhD
    • Sub-Investigator: Andrea Baroni, PT, PhD
    • Contact: Sofia Straudi, MD, PhD; Phone Number: 0532238720; Email: sofia.straudi@unife.it
    • Sub-Investigator: Antonino Casile, PhD
    • Sub-Investigator: Giulia Fregna, PT, MSc, PhD student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR group; All participants will receive an hour of VR training 5 times/week for 4 weeks within the daily rehab routine.	Device: 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.; Other Names: Head-mounted display
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Spasticity	Spasticity grade at the paretic upper limb will be measured with the Ashworth Scale (0-5), in which higher scores are related to more severe muscle hypertonia	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	Patient's independence will be quantified with the Barthel Index	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	Stroke Impact Scale 2.0 will be performed for investigating the perceived quality of life, higher scores indicate better quality of life perceived	Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)
Kinematic data	Instrumental data of hand movements registered during the sessions (relevant kinematic indexes will be recorded and offline analyzed such as hand trajectories and peak velocity)	Parameters changes (e.g. hand peak velocities) before (T0) and after (T1) the 4 weeks of treatment
Electroencephalogram	The EEG signals will be measured by means of a 32-channel cap, according to the International 10-20 system, recorded and monitored by computerized devices.	Data changes before (T0) and after (T1) the 4 weeks of treatment (4 weeks) and at 6-month follow-up (T2)
Treatment satisfaction	The satisfaction related to the virtual training will be investigated through a specific questionnaire	After 4 weeks
Embodiment	The embodiment feeling will be analyzed with the Gonzalez-Franco questionnaire	After 4 weeks
Cybersickness	For monitoring undesirable events the Simulator Sickness Questionnaire will be used	After 4 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: stroke; rehabilitation; upper limb; immersive virtual reality; subacute stroke; head-mounted display
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: VR_STROKE_MULTICENTER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No