StrokeNCT04944004
Effectiveness of Computer-based Cognitive Training for Executive Functions After Stroke
A study testing CogniPlus and Training As Usual (TAU) in people with Stroke and Executive Dysfunction, run by TWGHs Wong Tai Sin Hospital.
Trial summary
Objective: To determine the efficacy of computer-based cognitive training(CBCT) in patients with stroke in the community settings. Study Design: Single-blinded prospective, pre-test/post-test randomized controlled trial (RCT) will be conducted in 2 groups of participants that receiving training in community settings. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Stroke, Executive Dysfunction, Cognitive Impairment
- What is being tested?
- CogniPlus and Training As Usual (TAU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 31 Oct 2022
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are suffered from unilateral hemispheric stroke and with a confirmation by neuroimaging evidence from either computer tomography (CT) or magnetic resonance imaging (MRI);
- Patients are either at subacute stage or chronic stage, i.e. the patients are suffered from post-stroke after one month,
- Patients are age 60 years old or above;
- Patients are medically stable;
- Patients are Cantonese speaking,
- Patients can communicate and to follow at least three-step commands, and;
- Patients are willing to give written consent.
Who cannot join
- Patients are at acute stage, i.e the patients are suffered from stroke within 1 week;
- Patients with severe aphasia, swallowing disorders or other complications post-stroke that prevent them from successfully completing the assessments;
- Patients with any previously known psychiatric disorder or neurological disease excluding stroke;
- Patients are unable to given written consent.
Trial locations and contacts
No sites are listed yet.
About this study
Objective:
To determine the efficacy of computer-based cognitive training(CBCT) in patients with stroke in the community settings.
Read more
Study Design:
Single-blinded prospective, pre-test/post-test randomized controlled trial (RCT) will be conducted in 2 groups of participants that receiving training in community settings. Treatment groups will attend individualized CBCT programme using CogniPlus® while control group will continue attend conventional treatment as usual (TAU). Assessment on the means difference in assessing functions will be done after the study.
Samples:
100 patients with stroke will be recruited from the community, using a sampling frame of selected diagnosis and homogeneity.
Expected Findings:
Find out the training effects of selected CBCT on EF and daily functioning in patients with stroke
Read the detailed description
It is important to study the effectiveness of intervention post-stroke cognitive deficits in EF, Post-stroke patients with EF deficits will affect their abilities to successfully return to normal daily activity. Studies over the past decade have provided evidence of substantial gaps in our knowledge on how to effectively manage EF impairment post-stroke. To address these gaps there has been growing attention and research into the management of EF impairment post-stroke. Studies have been conducted to address some of these gaps specific to EF impairment and intervention research, and to investigate use of evidence-based practices for the management of EF impairment post-stroke. The literatures review of EF interventions identified different treatment approaches that were showing promise in helping persons with stroke to cope with EF deficits. The preliminary evidence on specific EF skill retraining suggested that structured, individualized, and intense computerized EF training could improve targeted EF impairments. Stroke patients with EF deficits often find it difficult in their daily activities, the impact of treatment might have potential to enhance rehabilitation and recovery. The translational framework described in (figure IV) describe ways to identify and investigate the evidence for the use of CBCT in specific EF interventions post-stroke. The study is thus required to find the impact of CBCT on a variety of outcomes, including not only measures of EF impairment, but also measures of daily activities and participation in everyday life situations that are affected in stroke patients having EF disorders.
- Being tested
- CogniPlus, Training As Usual (TAU)
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CogniPlusOther
The CBCT programmes proposed in this study is called CogniPlus. This software package offers training of scientifically proven trainable cognitive functions. According to the user manual, the lifelike interactive system and its automatic adaptability to client's ability level made CogniPlus feasible in community settings.
Training As Usual (TAU)Other
Training As Usual (TAU)
| Study group | Role | What they receive |
|---|---|---|
| Experimental CBCT Group | Experimental | Participants of CBCT group will attend individual computer-based cognitive training sessions. Researcher will give instruction in the use of the computerized training programs and assists participants during their training sessions. Receives: Other: CogniPlus |
| Training As Usual (TAU) Group | Active comparator | Participants of TAU group will attend usual training sessions offered by the training centres with similar intensity and frequency as the CBCT training. Receives: Other: Training As Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Wisconsin Card Sorting Test Score
The test consists of 128 card designs, participant is required to sort the cards under the categorization rules and feedback from examiner in about 20 minutes. The more categories achieved (range 0 to 6) and less perseverative errors (out of 128 trials) the better executive control. Moreover, the lower the total number of trials administered (total number of cards used) reflects greater efficiency of the participant in the task; in addition, the greater the total number of correct responses (number of successes in combinations according to the category) and the lower the total number of errors (number of incorrect combinations) also indicate the better the participant's performance.
Measured: Baseline, after completion of half of the programme (an average of 8 weeks), one month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TWGHs Wong Tai Sin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Principal investigator, Li Kwok Fai Ray, TWGHs Wong Tai Sin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944004
- Sponsor's protocol ID
- HongKongPolyuRL
- Status last verified
- Jun 2021
- First submitted
- 22 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Computer-based Cognitive Training for Executive Functions After Stroke
- ClinicalTrials.gov ID
- NCT04944004
- Acronym / sponsor ID
- HongKongPolyuRL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- TWGHs Wong Tai Sin HospitalUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 29 Jun 2021 (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.
Objective:
To determine the efficacy of computer-based cognitive training(CBCT) in patients with stroke in the community settings.
Study Design:
Single-blinded prospective, pre-test/post-test randomized controlled trial (RCT) will be conducted in 2 groups of participants that receiving training in community settings. Treatment groups will attend individualized CBCT programme using CogniPlus® while control group will continue attend conventional treatment as usual (TAU). Assessment on the means difference in assessing functions will be done after the study.
Samples:
100 patients with stroke will be recruited from the community, using a sampling frame of selected diagnosis and homogeneity.
Expected Findings:
Find out the training effects of selected CBCT on EF and daily functioning in patients with stroke
Detailed description
It is important to study the effectiveness of intervention post-stroke cognitive deficits in EF, Post-stroke patients with EF deficits will affect their abilities to successfully return to normal daily activity. Studies over the past decade have provided evidence of substantial gaps in our knowledge on how to effectively manage EF impairment post-stroke. To address these gaps there has been growing attention and research into the management of EF impairment post-stroke. Studies have been conducted to address some of these gaps specific to EF impairment and intervention research, and to investigate use of evidence-based practices for the management of EF impairment post-stroke. The literatures review of EF interventions identified different treatment approaches that were showing promise in helping persons with stroke to cope with EF deficits. The preliminary evidence on specific EF skill retraining suggested that structured, individualized, and intense computerized EF training could improve targeted EF impairments. Stroke patients with EF deficits often find it difficult in their daily activities, the impact of treatment might have potential to enhance rehabilitation and recovery. The translational framework described in (figure IV) describe ways to identify and investigate the evidence for the use of CBCT in specific EF interventions post-stroke. The study is thus required to find the impact of CBCT on a variety of outcomes, including not only measures of EF impairment, but also measures of daily activities and participation in everyday life situations that are affected in stroke patients having EF disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental CBCT Group | Experimental | Other: CogniPlusParticipants of CBCT group will attend individual computer-based cognitive training sessions. Researcher will give instruction in the use of the computerized training programs and assists participants during their training sessions. |
| Training As Usual (TAU) Group | Active comparator | Other: Training As Usual (TAU)Participants of TAU group will attend usual training sessions offered by the training centres with similar intensity and frequency as the CBCT training. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients are suffered from unilateral hemispheric stroke and with a confirmation by neuroimaging evidence from either computer tomography (CT) or magnetic resonance imaging (MRI);
- Patients are either at subacute stage or chronic stage, i.e. the patients are suffered from post-stroke after one month,
- Patients are age 60 years old or above;
- Patients are medically stable;
- Patients are Cantonese speaking,
Key exclusion criteria (4 listed)
- Patients are at acute stage, i.e the patients are suffered from stroke within 1 week;
- Patients with severe aphasia, swallowing disorders or other complications post-stroke that prevent them from successfully completing the assessments;
- Patients with any previously known psychiatric disorder or neurological disease excluding stroke;
- Patients are unable to given written consent.
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 |
|---|---|---|
| CogniPlusThe CBCT programmes proposed in this study is called CogniPlus. This software package offers training of scientifically proven trainable cognitive functions. According to the user manual, the lifelike interactive system and its automatic adaptability to client's ability level made CogniPlus feasible in community settings. | Other | Experimental CBCT Group |
| Training As Usual (TAU)Training As Usual (TAU) | Other | Training As Usual (TAU) Group |
Primary outcome
Change of Wisconsin Card Sorting Test Score
Time frame: Baseline, after completion of half of the programme (an average of 8 weeks), one month post-treatment
The test consists of 128 card designs, participant is required to sort the cards under the categorization rules and feedback from examiner in about 20 minutes. The more categories achieved (range 0 to 6) and less perseverative errors (out of 128 trials) the better executive control. Moreover, the lower the total number of trials administered (total number of cards used) reflects greater efficiency of the participant in the task; in addition, the greater the total number of correct responses (number of successes in combinations according to the category) and the lower the total number of errors (number of incorrect combinations) also indicate the better the participant's performance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing CogniPlus and Training As Usual (TAU) in people with Stroke and Executive Dysfunction, run by TWGHs Wong Tai Sin Hospital.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ray Li, MSc (852 98312636, rayliot@yahoo.com.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Wisconsin Card Sorting Test Score (time frame: Baseline, after completion of half of the programme (an average of 8 weeks), one month post-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 29 Jun 2021.