Rehabilitation, Stroke, Telemedicine, Telerehabilitation
Conditions
Keywords
stroke, telemedicine, rehabilitation
Brief summary
The aim of the study is to evaluate whether a computer-based cognitive treatment delivered via tele-rehabilitation produces an improvement in cognitive functioning comparable to the improvement achievable through the same treatment delivered in person in patients with stroke outcomes. To investigate, using a custom-designed questionnaire, the feasibility and patient satisfaction with the rehabilitative treatment delivered via telemedicine compared to the same treatment delivered in person.
Interventions
BEHAVIORALTelerehabilitation
Three hours of cognitive rehabilitation per week, performed remotely and independently, using a computerized device, which is pre-programmed based on the patient's needs.
BEHAVIORALTraditional in-person rehabilitation.
Three hours of in-person cognitive rehabilitation per week using a computerized device.
Sponsors
Universita di Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of ischemic or hemorrhagic stroke; * Age between 18 and 90 years; * First stroke event; * Stroke occurred more than 30 days ago; * Adequate level of understanding; * Presence of one or more of the following cognitive disorders: * Memory disorders * Attention disorders * Executive function disorders * Availability of an internet connection at the patient's home necessary for the telemedicine procedures.
Exclusion criteria
* Presence of other neurological disorders; * Presence of pre-morbid cognitive decline; * Psychiatric disorders in the medical history; * Alcohol and/or drug abuse; * Presence of severe uncorrected visual deficits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trail Making Test Part B (TMT-B) | From enrollment to the end of treatment and 2 months until the end of treatment | Used as a measure of attentional set-shifting and mental flexibility. Time needed to complete the tasks is recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Trail Making Test - A (TMT-A) | From enrollment to the end of treatment and 2 months until the end of treatment | Used as a measure of psychomotor speed and visual search/attention skills |
| Memory with interference - ENB 2 | From enrollment to the end of treatment and 2 months until the end of treatment | to assess working memory through the memorization of letter triplets alongside a distracting task lasting 10 seconds in the first part and 30 seconds in the second. The maximum obtainable score is 9 for both parts of the test. |
| Dual task test | From enrollment to the end of treatment and 2 months until the end of treatment | Dual Task to assess the ability to perform two tasks simultaneously (one verbal and one visuomotor) |
| Elithorn's Perceptual Maze Test | From enrollment to the end of treatment and 2 months until the end of treatment | to investigate problem-solving abilities. |
| 15 Words of Rey | From enrollment to the end of treatment and 2 months until the end of treatment | To assess verbal learning ability and long-term verbal memory (IMMEDIATE RECALL: score ranging from 0 to 75. DELAYED RECALL: score ranging from 0 to 15). |
| Functional Independence Measure (FIM) | From enrollment to the end of treatment and 2 months until the end of treatment | To evaluate the degree of disability. |
| Hospital Anxiety and Depression Scale | From enrollment to the end of treatment and 2 months until the end of treatment | to assess the presence of depression and anxiety. |
| Short Form Health Survey 36 (SF-36) | From enrollment to the end of treatment and 2 months until the end of treatment | to evaluate quality of life. |
| Feasibility, Satisfaction, and Cost Questionnaire | From enrollment to the end of treatment and 2 months until the end of treatment | to assess the feasibility and satisfaction with the treatment and to evaluate the costs associated with it. |
| Stroop Test | From enrollment to the end of treatment and 2 months until the end of treatment | to assess the speed and accuracy of automatic response inhibition. |
Countries
Italy
Outcome results
None listed