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

NCT06755437 | Terminated DMC

• 1 other identifier: 269666
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Cognitive Deficits; Computerized Rehabilitation; Computerized Device

Keywords

stroke; neuropsychological rehabilitation

Outcome Measures

Primary Outcomes (1)

• Trail Making Test Part A (TMT-A)

  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 Outcomes (4)

• Trail Making Test Part B (TMT-B)

  From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)

• Dual task test

  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

  From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)

• Stroop Test

  From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)

Study Arms (2)

Rehabilitation with a computerized device

EXPERIMENTAL

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); Device: Self-treatment with a computerized device (in the afternoon)

Rehabilitation with pencil-and-paper exercises

ACTIVE COMPARATOR

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.

Interventions

Rehabilitation with a computerized device (in the morning) DEVICE

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

Rehabilitation with a computerized device

Self-treatment with a computerized device (in the afternoon) DEVICE

In the afternoon, the experimental group performed 60 min. self-guided treatment with the electronic device.

Rehabilitation with a computerized device

self-treatment with pencil-and-paper exercises (in the afternoon) BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione

Verona, Italy

Location

MeSH Terms

Conditions

Stroke; Cognition Disorders

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 1, 2025
• Study Start: October 2, 2017
• Primary Completion: December 30, 2021
• Study Completion: July 31, 2025
• Last Updated: August 6, 2025

Record last verified: 2024-10

Locations

IT (1)