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

NCT ID: NCT04944004

Last Updated: 2021-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-10-31

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

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.

Conditions

Stroke; Executive Dysfunction; Cognitive Impairment; Randomized Controlled Trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental CBCT Group

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.

Group Type: EXPERIMENTAL

CogniPlus

Intervention Type: 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.

Training As Usual (TAU) Group

Participants of TAU group will attend usual training sessions offered by the training centres with similar intensity and frequency as the CBCT training.

Group Type: ACTIVE_COMPARATOR

Training As Usual (TAU)

Intervention Type: OTHER

Training As Usual (TAU)

Interventions

CogniPlus

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.

Intervention Type: OTHER

Training As Usual (TAU)

Training As Usual (TAU)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients are suffered from unilateral hemispheric stroke and with a confirmation by neuroimaging evidence from either computer tomography (CT) or magnetic resonance imaging (MRI);

2. Patients are either at subacute stage or chronic stage, i.e. the patients are suffered from post-stroke after one month,

3. Patients are age 60 years old or above;

4. Patients are medically stable;

5. Patients are Cantonese speaking,

6. Patients can communicate and to follow at least three-step commands, and;

7. Patients are willing to give written consent.

Exclusion Criteria

1. Patients are at acute stage, i.e the patients are suffered from stroke within 1 week;

2. Patients with severe aphasia, swallowing disorders or other complications post-stroke that prevent them from successfully completing the assessments;

3. Patients with any previously known psychiatric disorder or neurological disease excluding stroke;

4. Patients are unable to given written consent.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: collaborator

TWGHs Wong Tai Sin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li Kwok Fai Ray

Mr. Ray Li

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ray Li, MSc

Role: CONTACT

rayliot@yahoo.com.hk

852 98312636

Other Identifiers

HongKongPolyuRL

Identifier Type: -

Identifier Source: org_study_id