Tele-rehabilitation for Cognitive Disorders

January 21, 2025 updated by: Valentina Varalta, Universita di Verona

Tele-rehabilitation for Cognitive Disorders: a Randomized Controlled Trial in Patients with Stroke Outcomes

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Verona, Italy
        • Sezione medicina fisica e riabilitativa dipartimento di neuroscienze

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telerehabilitation group
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.
Behavioral: Telerehabilitation
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.
Active Comparator: In-person treatment
Three hours of in-person cognitive rehabilitation per week using a computerized device.
Behavioral: Traditional in-person rehabilitation.
Three hours of in-person cognitive rehabilitation per week using a computerized device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trail Making Test Part B (TMT-B)
Time Frame: 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.
From enrollment to the end of treatment and 2 months until the end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Trail Making Test - A (TMT-A)
Time Frame: 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
From enrollment to the end of treatment and 2 months until the end of treatment
15 Words of Rey
Time Frame: 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).
From enrollment to the end of treatment and 2 months until the end of treatment
Memory with interference - ENB 2
Time Frame: 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.
From enrollment to the end of treatment and 2 months until the end of treatment
Dual task test
Time Frame: 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)
From enrollment to the end of treatment and 2 months until the end of treatment
Elithorn's Perceptual Maze Test
Time Frame: From enrollment to the end of treatment and 2 months until the end of treatment
to investigate problem-solving abilities.
From enrollment to the end of treatment and 2 months until the end of treatment
Stroop Test
Time Frame: 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.
From enrollment to the end of treatment and 2 months until the end of treatment
Functional Independence Measure (FIM)
Time Frame: From enrollment to the end of treatment and 2 months until the end of treatment
To evaluate the degree of disability.
From enrollment to the end of treatment and 2 months until the end of treatment
Hospital Anxiety and Depression Scale
Time Frame: From enrollment to the end of treatment and 2 months until the end of treatment
to assess the presence of depression and anxiety.
From enrollment to the end of treatment and 2 months until the end of treatment
Short Form Health Survey 36 (SF-36)
Time Frame: From enrollment to the end of treatment and 2 months until the end of treatment
to evaluate quality of life.
From enrollment to the end of treatment and 2 months until the end of treatment
Feasibility, Satisfaction, and Cost Questionnaire
Time Frame: 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.
From enrollment to the end of treatment and 2 months until the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita di Verona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3623CESC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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