Clinical trial NCT06892886: Using Immersive Virtual Reality for the Upper Limb Rehabilitation of Post-stroke Subjects
Official title: Using Immersive Virtual Reality for the Upper Limb Rehabilitation of Post-stroke Subjects: a Multicenter Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sub-acute Stroke
Keywords: stroke
rehabilitation
upper limb
immersive virtual reality
head-mounted display
subacute stroke
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
Collaborators: name: Ospedale Accreditato Villa Bellombra
name: Casa di Cura Città di Rovigo
name: IRCCS Centro Neurolesi Bonino Pulejo
First posted: 2025-03-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in upper limb impairment
timeFrame: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)
Secondary outcomes:
measure: Change in Spasticity
timeFrame: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)
measure: Change in Activities of Daily Living
timeFrame: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)
measure: Change in perceived quality of life
timeFrame: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)
measure: Kinematic data
timeFrame: Parameters changes (e.g. hand peak velocities) before (T0) and after (T1) the 4 weeks of treatment
measure: Electroencephalogram
timeFrame: Data changes before (T0) and after (T1) the 4 weeks of treatment (4 weeks) and at 6-month follow-up (T2)
measure: Treatment satisfaction
timeFrame: After 4 weeks
measure: Embodiment
timeFrame: After 4 weeks
measure: Cybersickness
timeFrame: After 4 weeks
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Ferrara University Hospital
Study officials:
References: