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

Not Applicable

Recruiting

• Conditions: Sub-acute Stroke

• Registration Number: NCT06892886
• Lead Sponsor: University Hospital of Ferrara

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-30
• Study Start: 2023-03-01
• Status Verified: 2024-11
• Study First Submitted QC: 2025-03-17
• Last Update Submitted: 2025-03-17
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in upper limb impairment	Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)	Motor recovery will be assessed through the Fugl Meyer Assessment - Upper Extremity

Secondary Outcome Measures

Name	Time	Method
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)	Stroke Impact Scale 2.0 will be performed for investigating the perceived quality of life, higher scores indicate better quality of life perceived
Change in Spasticity	Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)	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
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)	Patient's independence will be quantified with the Barthel Index
Kinematic data	Parameters changes (e.g. hand peak velocities) before (T0) and after (T1) the 4 weeks of treatment	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)
Electroencephalogram	Data changes before (T0) and after (T1) the 4 weeks of treatment (4 weeks) and at 6-month follow-up (T2)	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.
Treatment satisfaction	After 4 weeks	The satisfaction related to the virtual training will be investigated through a specific questionnaire
Embodiment	After 4 weeks	The embodiment feeling will be analyzed with the Gonzalez-Franco questionnaire
Cybersickness	After 4 weeks	For monitoring undesirable events the Simulator Sickness Questionnaire will be used

Trial Locations

Locations (1)

Ferrara University Hospital; 🇮🇹 Ferrara, Italy