Using Immersive Virtual Reality for the Upper Limb Rehabilitation of Post-stroke Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Reality.
- Who it may be relevant to
- Registry conditions: Sub-acute Stroke. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Using Immersive Virtual Reality for the Upper Limb Rehabilitation of Post-stroke Subjects: a Multicenter Randomized Control Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Changes in upper limb impairment [Time frame: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)]
Secondary outcome measures (8)
- Change in Spasticity [Time frame: 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 [Time frame: 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 [Time frame: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)]
- Kinematic data [Time frame: Parameters changes (e.g. hand peak velocities) before (T0) and after (T1) the 4 weeks of treatment]
- Electroencephalogram [Time frame: Data changes before (T0) and after (T1) the 4 weeks of treatment (4 weeks) and at 6-month follow-up (T2)]
- Treatment satisfaction [Time frame: After 4 weeks]
- Embodiment [Time frame: After 4 weeks]
- Cybersickness [Time frame: After 4 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Ferrara University Hospital — Ferrara
Identifiers
NCT: NCT06892886 · VR_STROKE_MULTICENTER