An interventional study of Telerehabilitation - VRRS Khymeia in Stroke, sponsored by IRCCS San Camillo, Venezia, Italy. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-30.
Sponsored by IRCCS San Camillo, Venezia, Italy · Not applicable, Interventional, and Treatment
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.
7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.
This study's enrollment of 84 is above the median of 50 across 5,370 interventional studies indexed under Stroke.
Browse Stroke studies →IRCCS San Camillo, Venezia, Italy is the lead sponsor of 48 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients will receive a kit home-based consisting of a tablet home, an exercise equipment and access to a daily individualized training program based on their needs (i.e., motor, language and/or cognitive training programs). The exercise program and patients' sessions will be remotely supervised by therapists.
Behavioral: Telerehabilitation - 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.
Feasibility of telerehabilitation system
Feasibility will be measured by calculating the adherence to treatment (i.e. percentage of training sessions completed).
Time frame: 6 weeks
Feasibility of telerehabilitation system
Feasibility will be measured with the Technology Acceptance Model (TAM), a specific questionnaire used to quantify the likelihood of technology acceptance, consisting of 12 items, six assessing perceived usefulness and six assessing perceived ease of use.
Time frame: 6 weeks
Feasibility of telerehabilitation system
Feasibility will be measured with the System Usability Questionnaire (SUS), a 10 item questionnaire with five response options: from Strongly agree to Strongly disagree.
Time frame: 6 weeks
Change in measure of quality of life
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.
Time frame: Baseline up to 6 weeks
Change in measure of quality of life
Quality of life will be measured by the EuroQol-5 dimensions (EQ-5D), a questionnaire measuring 5 dimensions described by 3 possible levels of problems (i.e., none, mild-to-moderate, severe). Respondent's answers are translated into a preference-based score, yielding an index score based on a scale from 0.000 (death) to 1.000 (perfect health). The 5 dimensions can be converted to a single utility value (EQ-Index score).
Time frame: Baseline up to 6 weeks
Change in motor functions
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.
Time frame: Baseline up to 6 weeks
Change in motor functions
Assessed with the Nine hole pegboard test (NHPT), to measure finger dexterity. It is administered by asking the participant to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. Scores are based on the time taken to complete the activity, recorded in seconds.
Time frame: Baseline up to 6 weeks
Change in motor functions
Assessed with the Box and block test (BBT). The patient has to carry as much cubes as possible, one by one, from a container to another one in one minute. The test is performed with both hands.
Time frame: Baseline up to 6 weeks
Change in motor functions
Assessed with the Ashworth Spasticity Scale. The therapist evaluates the spasticity of the muscles. There are 5 values: 0 (no increase in muscle tone), 1 (slight increase in muscle tone), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone), 4 (affected part rigid in flexion or extension).
Time frame: Baseline up to 6 weeks
Change in linguistic functions
Aachen Aphasie Test (AAT)
Time frame: Baseline up to 6 weeks
Change in cognitive functions
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.
Time frame: Baseline up to 6 weeks
Change in cognitive functions
Assessed with the Bells test, a cancellation test that allows for a quantitative and qualitative assessment of visual neglect in the near extra personal space. The total number of cancelled bells is recorded as well as the time taken to complete. The maximum score is 35.
Time frame: Baseline up to 6 weeks
Change in cognitive functions
Assessed with the verbal fluency test. Participants have to produce as many words as possible from a semantic and a phonemic category in 1 minute.
Time frame: Baseline up to 6 weeks
Change in Independence (Activities of Daily Living)
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).
Time frame: Baseline up to 6 weeks
Change in behavior (depression)
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.
Time frame: Baseline up to 6 weeks
Change in caregiver burden
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.
Time frame: Baseline up to 6 weeks
Satisfaction of the treatment
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.
Time frame: 6 weeks
Plan to share: No
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
IRCCS San Camillo, Venezia, Italy