Stroke
Conditions
Keywords
Stroke, Telerehabilitation, Feasibility, Virtual reality
Brief summary
The main aim of this longitudinal, pilot study is to evaluate the feasibility of a multi-domain (i.e., motor, language and cognitive domains) telerehabilitation system using the Virtual Reality Rehabilitation System (VRRS, Khymeia) in patients with stroke. Furthermore, data on patients' needs and clinical data will be collected before and after treatment and then analyzed.
Interventions
BEHAVIORALTelerehabilitation - VRRS Khymeia
Participants will receive an individualized, multidomain exercise program set up by the therapist, based on their needs. The intervention applied will consist of 20 sessions of motor, language and/or cognitive training distributed in five sessions for week, each lasting 1 hour. Remotely, the therapist will supervise the participant's exercise program.
Sponsors
IRCCS Centro Neurolesi Bonino Pulejo
Fondazione Don Carlo Gnocchi Onlus
Fondazione Mondino
IRCCS San Raffaele Roma
Istituto Clinico Humanitas
IRCCS San Camillo, Venezia, Italy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Single ischemic stroke documented by CT/ MRI; * 2 to 18 months after the event.
Exclusion criteria
* medical history or presence of cognitive decline (MoCA\<17.54) * recent fractures * History of mental disorders (major depression, psychosis) * History/presence of other neurological disorders that may interfere with outcome * Presence of other internal pathologies that may interfere with outcome or treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of telerehabilitation system | 6 weeks | Feasibility will be measured by calculating the adherence to treatment (i.e. percentage of training sessions completed). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Independence (Activities of Daily Living) | Baseline up to 6 weeks | Assessed with the Barthel Index (BI). It comprises 10 ADL/mobility activities, items are rated based on the amount of assistance required to complete each activity. Each item score ranges from 0 (dependent) to 10 (independent). |
| Change in measure of quality of life | Baseline up to 6 weeks | Quality of life will be measured by the Short-Form-36 Health Survey (SF-36), a questionnaire comprising 36 questions that cover 8 domains of health. Each of the 8 summed scores is linearly transformed onto a scale from 0 (negative health) to 100 (positive health) to provide a score for each domain. Each domain can be used independently. |
| Change in motor functions | Baseline up to 6 weeks | Change in motor functions will be assessed with the Fugl-Meyer Assessment (FMA), a stroke-specific scale which assesses the motor functioning in patients with post-stroke. There are 3 values for each of the 5 domain: 0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The 5 domains assessed include: motor function (upper limb maximum score = 66; lower limb maximum score = 34), sensory function (maximum score = 24), balance (maximum score = 14), joint range of motion (maximum score = 44), joint pain (maximum score = 44), for an overall maximum score of 226 points. |
| Change in cognitive functions | Baseline up to 6 weeks | Assessed with the Montreal Cognitive Assessment (MoCA), a cognitive screening tool comprising 16 items and 11 categories to assess multiple cognitive domains. The total possible score is 30, corresponding to a good performance. |
| Change in behavior (depression) | Baseline up to 6 weeks | Assessed with the Beck Depression Inventory (BDI). Items are on a four-point scale that ranges from 0 to 3. Ratings are summed to provide a total score ranging from 0-63. Scores \>10 generally meet the threshold for a diagnosis of depression. |
| Change in caregiver burden | Baseline up to 6 weeks | Assessed with the Zarit Burden Interview (ZBI). It comprises 22 items with a score ranging from 0 (never to 4 (nearly always). Total scores are obrained by summing all items endorsed. |
| Satisfaction of the treatment | 6 weeks | Client Satisfaction Questionnaire, it consists of a 6 item questionnaire with five response options: from 0 to 4, where 0 reflects a negative response and 4 reflects a positive response. |
| Change in linguistic functions | Baseline up to 6 weeks | Aachen Aphasie Test (AAT) |
Countries
Italy
Outcome results
None listed