Effectiveness of Computer-based Cognitive Training for Executive Functions After Stroke

NCT04944004 | Unknown DMC

• 1 other identifier: HongKongPolyuRL
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Stroke; Executive Dysfunction; Cognitive Impairment; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, after completion of half of the programme (an average of 8 weeks), one month post-treatment

Study Arms (2)

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.

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.

Other: Training As Usual (TAU)

Interventions

CogniPlus OTHER

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.

Experimental CBCT Group

Training As Usual (TAU) OTHER

Training As Usual (TAU)

Training As Usual (TAU) Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TWGHs Wong Tai Sin Hospital: lead
• The Hong Kong Polytechnic University: collaborator

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Ray Li, MSc

CONTACT

852 98312636; rayliot@yahoo.com.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr. Ray Li

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 29, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: October 31, 2022
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share