Using Immersive Virtual Reality for the Upper Limb Rehabilitation of Post-stroke Subjects: a Multicenter Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Changes in upper limb impairment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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)
Motor recovery will be assessed through the Fugl Meyer Assessment - Upper Extremity
Secondary Outcomes
- 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))
- Treatment satisfaction(After 4 weeks)
- Embodiment(After 4 weeks)
- Cybersickness(After 4 weeks)