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

NCT ID: NCT06755437

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-02

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Cognitive Deficits Computerized Rehabilitation Computerized Device

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Rehabilitation with a computerized device (in the morning)

Intervention Type 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

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

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

No interventions assigned to this group

Interventions

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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

Intervention Type 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.

Intervention Type DEVICE

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universita di Verona

OTHER

Sponsor Role lead

Responsible Party

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Valentina Varalta

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione

Verona, , Italy

Site Status

Countries

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Italy

Other Identifiers

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269666

Identifier Type: -

Identifier Source: org_study_id

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