StrokeNCT06755437
Self Treatment With an Electronic Device for Cognitive Rehabilitation in Patients With Subacute Stroke
A study testing Rehabilitation with a computerized device (in the morning), Self-treatment with a computerized device (in the afternoon) and self-treatment with pencil-and-paper exercises (in the afternoon) in people with Stroke and Cognitive Deficits, run by Universita di Verona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Cognitive Deficits, Computerized Rehabilitation
- What is being tested?
- Rehabilitation with a computerized device (in the morning), Self-treatment with a computerized device (in the afternoon) and self-treatment with pencil-and-paper exercises (in the afternoon)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 2 Oct 2017to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione
Verona
About this study
Official title: Self Treatment With an Electronic Device for Cognitive Rehabilitation in Patients With Subacute Stroke: A Randomized Controlled Trial
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.
- Being tested
- Rehabilitation with a computerized device (in the morning), Self-treatment with a computerized device (in the afternoon), self-treatment with pencil-and-paper exercises (in the afternoon)
- Keywords
- stroke, neuropsychological rehabilitation
- Medical subject headings
- Stroke, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
self-treatment with pencil-and-paper exercises (in the afternoon)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)
Dual task test
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.
Measured: 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
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.
Measured: From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)
Stroop Test
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.
Measured: From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start2 Oct 2017
- Primary completion30 Dec 2021
- Study completion31 Jul 2025
Why it stopped: The study was terminated early due to recruitment challenges related to the large sample size required to achieve adequate statistical power.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Varalta, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755437
- Sponsor's protocol ID
- 269666
- Status last verified
- Oct 2024
- First submitted
- 18 Dec 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Treatment With an Electronic Device for Cognitive Rehabilitation in Patients With Subacute Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06755437
- Acronym / sponsor ID
- 269666
- Keywords
- stroke, neuropsychological rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to recruitment challenges related to the large sample size required to achieve adequate statistical power.
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation with a computerized device | Experimental | Device: Rehabilitation with a computerized device (in the morning), Device: Self-treatment with a computerized device (in the afternoon)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. |
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Rehabilitation with a computerized 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. | Device | Rehabilitation with a computerized 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 | Behavioural | – |
Primary outcome
Trail Making Test Part A (TMT-A)
Time frame: 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.
4 secondary outcomes
Trail Making Test Part B (TMT-B)
Time frame: From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)
Dual task test
Time frame: 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
Time frame: From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)
Stroop Test
Time frame: From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)
Results and safety
The study was stopped early (reason given: The study was terminated early due to recruitment challenges related to the large sample size required to achieve adequate statistical power.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation with a computerized device (in the morning), Self-treatment with a computerized device (in the afternoon) and self-treatment with pencil-and-paper exercises (in the afternoon) in people with Stroke and Cognitive Deficits, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early due to recruitment challenges related to the large sample size required to achieve adequate statistical power.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trail Making Test Part A (TMT-A) (time frame: From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.