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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06755437
Enrollment
80
Registered
2025-01-01
Start date
2017-10-02
Completion date
2025-07-31
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Deficits, Computerized Device, Computerized Rehabilitation, Stroke

Keywords

stroke, neuropsychological rehabilitation

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.

Interventions

DEVICERehabilitation 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

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

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

BEHAVIORALself-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

Sponsors

Universita di Verona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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 testFrom 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 TestFrom 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 TestFrom 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026