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

Not Applicable

Terminated

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

• Registration Number: NCT06755437
• Lead Sponsor: Universita di Verona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-02
• Primary Completion: 2021-12-30
• Status Verified: 2024-10
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-24
• Study First Posted: 2025-01-01
• Study Completion: 2025-07-31
• Last Update Submitted: 2025-08-01
• Last Update Posted: 2025-08-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Trail Making Test Part A (TMT-A)	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.

Secondary Outcome Measures

Name	Time	Method
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)	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.
Dual task test	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.
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)	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.
Stroop Test	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.

Trial Locations

Locations (1)

Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione; 🇮🇹 Verona, Italy