Self Treatment With an Electronic Device for Cognitive Rehabilitation in Patients With Subacute Stroke

August 1, 2025 updated by: Valentina Varalta, Universita di Verona

Self Treatment With an Electronic Device for Cognitive Rehabilitation in Patients With Subacute Stroke: A Randomized Controlled Trial

The objective of this study is to evaluate whether the independent use of an electronic device by a patient with stroke outcomes can enhance the effectiveness of rehabilitative treatment for attentional functions compared to standard treatment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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
        • Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione

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
  • Within 2 weeks since stroke onset
  • Age under 85 years
  • Attention deficits as measured by the Trails task or the Broken Hearts subtest in the Oxford Cognitive Screen (OCS)

Exclusion criteria:

  • Visual impairment documented by clinical history (e.g., cataracts, diabetic retinopathy, glaucoma, hemianopia)
  • Uncompensated psychiatric disorders
  • Drug or alcohol abuse
  • History of dementia
  • Severe comprehension disorders as determined by the Semantics subtest in the Oxford Cognitive Screen (OCS)
  • Spatial neglect as determined by the Broken Hearts subtest in the OCS

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: Rehabilitation with a computerized device
Every morning both groups received the same face-to-face cognitive treatment using an electronic device. in the afternoon only the experimental group performed self-treatment with the same device for 2 weeks, 5 sessions a week, for a total of 10 sessions.
Device: Rehabilitation with a computerized device (in the morning)
Each group received face-to-face cognitive rehabilitation with the electronic device for 45 min. The exercises were selected by the therapist and divided into four sessions of 2 to 3 days each. Each session included 40 min of activity and 5 minute of break
Device: Self-treatment with a computerized device (in the afternoon)
In the afternoon, the experimental group performed 60 min. self-guided treatment with the electronic device.
Active Comparator: Rehabilitation with pencil-and-paper exercises
Every morning both groups received the same face-to-face cognitive treatment using an electronic device. Only the control group performed self-treatment with paper-and-pencil exercises for 2 weeks, 5 sessions a week, for a total of 10 sessions.
Device: Rehabilitation with a computerized device (in the morning)
Each group received face-to-face cognitive rehabilitation with the electronic device for 45 min. The exercises were selected by the therapist and divided into four sessions of 2 to 3 days each. Each session included 40 min of activity and 5 minute of break
Behavioral: self-treatment with pencil-and-paper exercises (in the afternoon)
In the afternoon, the control group performed 60 min of cognitive self-treatment with conventional paper-and-pencil instruments. The therapist created a variety of exercises every day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trail Making Test Part A (TMT-A)
Time Frame: From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)
The Trail Making Test Part A (TMT-A) is a neuropsychological assessment that measures selective attention and processing speed. Participants connect a series of numbered circles in sequential order as quickly as possible. The score is determined by the time taken to complete the task, with shorter times indicating better performance. Errors may negatively impact the score.
From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trail Making Test Part B (TMT-B)
Time Frame: From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)
The Trail Making Test Part B (TMT-B) is a neuropsychological test that measures Divided attention. Participants must connect numbered and lettered circles in alternating order as quickly as possible. The score is based on the time taken to complete the test, with shorter times indicating better performance. Any errors may negatively impact the score.
From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)
Dual task test
Time Frame: From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)
Dual Task to assess the ability to perform two tasks simultaneously (one verbal and one visuomotor). Performance is evaluated based on accuracy and speed in both tasks, providing insight into how well an individual can manage competing cognitive and motor demands.
From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)
short version of the Elithorn's Perceptual Maze Test
Time Frame: From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)
The short version of the Elithorn's Perceptual Maze Test has a score range from 0 to 16, where the score is determined by the number of errors made during the task. Fewer errors correspond to better performance, with 0 indicating no errors and 16 representing the maximum number of errors. This test assesses planning, attention, and problem-solving skills, with lower scores reflecting more efficient cognitive functioning.
From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)
Stroop Test
Time Frame: From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)
The Stroop Test is a neuropsychological tool that assesses cognitive flexibility, selective attention, and the ability to inhibit automatic responses. Participants are required to name the color of the ink in which a word is printed, rather than reading the word itself. The score is based on the time taken to complete the task and the number of errors made when naming the ink colors. A higher score indicates more errors or a slower completion time, reflecting challenges in cognitive control and attention.
From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start 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)

October 2, 2017

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

December 18, 2024

First Submitted That Met QC Criteria

December 24, 2024

First Posted (Actual)

January 1, 2025

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 269666

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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