Clinical trial NCT06795672: Tele-rehabilitation for Cognitive Disorders
Official title: Tele-rehabilitation for Cognitive Disorders: a Randomized Controlled Trial in Patients with Stroke Outcomes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rehabilitation
Stroke
Telerehabilitation
Telemedicine
Keywords: stroke
telemedicine
rehabilitation
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Trail Making Test Part B (TMT-B)
timeFrame: From enrollment to the end of treatment and 2 months until the end of treatment
Secondary outcomes:
measure: The Trail Making Test - A (TMT-A)
timeFrame: From enrollment to the end of treatment and 2 months until the end of treatment
measure: 15 Words of Rey
timeFrame: From enrollment to the end of treatment and 2 months until the end of treatment
measure: Memory with interference - ENB 2
timeFrame: From enrollment to the end of treatment and 2 months until the end of treatment
measure: Dual task test
timeFrame: From enrollment to the end of treatment and 2 months until the end of treatment
measure: Elithorn's Perceptual Maze Test
timeFrame: From enrollment to the end of treatment and 2 months until the end of treatment
measure: Stroop Test
timeFrame: From enrollment to the end of treatment and 2 months until the end of treatment
measure: Functional Independence Measure (FIM)
timeFrame: From enrollment to the end of treatment and 2 months until the end of treatment
measure: Hospital Anxiety and Depression Scale
timeFrame: From enrollment to the end of treatment and 2 months until the end of treatment
measure: Short Form Health Survey 36 (SF-36)
timeFrame: From enrollment to the end of treatment and 2 months until the end of treatment
measure: Feasibility, Satisfaction, and Cost Questionnaire
timeFrame: From enrollment to the end of treatment and 2 months until the end of treatment
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Sezione medicina fisica e riabilitativa dipartimento di neuroscienze
Study officials:
References: