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

University of Verona

Status: Terminated

Conditions: Computerized Device; Computerized Rehabilitation; Stroke; Cognitive Deficits

Treatments: Device: Self-treatment with a computerized device (in the afternoon); Behavioral: self-treatment with pencil-and-paper exercises (in the afternoon); Device: Rehabilitation with a computerized device (in the morning)

Study type: Interventional

Funder types: Other

Identifiers

NCT06755437

269666

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Rehabilitation with a computerized device

Experimental group

Description:

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.

Treatment:

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 group

Description:

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.