Sub-acute Stroke
Conditions
Keywords
stroke, rehabilitation, upper limb, immersive virtual reality, head-mounted display, subacute stroke
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.
Interventions
DEVICEVirtual 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.
Sponsors
Ospedale Accreditato Villa Bellombra
Casa di Cura Città di Rovigo
IRCCS Centro Neurolesi Bonino Pulejo
University Hospital of Ferrara
Study design
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.
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
| 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 |
| 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 |
| 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. |
Countries
Italy
Contacts
Primary ContactSofia Straudi, MD, PhD
Outcome results
None listed