Tele-rehabilitation for Cognitive Disorders

Not Applicable

Terminated

• Conditions: Rehabilitation; Stroke; Telerehabilitation; Telemedicine

• Registration Number: NCT06795672
• Lead Sponsor: Universita di Verona

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-28
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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).
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.
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.
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.
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.

Trial Locations

Locations (1)

Sezione medicina fisica e riabilitativa dipartimento di neuroscienze; 🇮🇹 Verona, Italy