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Study Overview

Title:
Effect of computer-based working memory training on instrumental activities of daily living after ischemic stroke: A randomized clinical trial
Study is 3ie funded:
No
Study ID:
RIDIE-STUDY-ID-5e61da9608f23
Initial Registration Date:
03/05/2020
Last Update Date:
02/10/2020
Study Status:
In Development
Location(s):
Colombia
Abstract:

Ischemic stroke survivors show cognitive impairments which often persist in the chronic phase after the event. Working memory impairments, in particular, have a large impact on instrumental activities of daily living and may predict poor cognitive recovery after ischemic stroke. Recent studies have indicated that performance on instrumental activities of daily living can be improved through computer-based working memory training. The goal of this study is to determine the effect of a computer-based working memory training on instrumental activities after ischemic stroke.   

Registration Citation:
Categories:
Health, Nutrition, and Population
Additional Keywords:
working memory training, instrumental activities of daily living, ischemic stroke, functional independence
Secondary ID Number(s):
449011-19.02-013 Universidad San Buenaventura

Principal Investigator(s)

Name of First PI:
Daniel Landinez Martinez
Affiliation:
Universidad Catolica Luis amigo-Universidad San Buenaventura
Name of Second PI:
David Andres Montoya Arenas
Affiliation:
Universidad San Buenaventura-Universidad Pontificia Bolivariana

Study Sponsor

Name:
Universidad Catolica Luis amigo
Study Sponsor Location:
Colombia

Research Partner

Name of Partner Institution:
Caja de compensación familiar de Caldas "Clínica San Marcel"
Type of Organization:
Research institute/University
Location:
Colombia
Intervention

Intervention Overview

Intervention:

The aim of this study is to is to determine the effect of a computer-based working memory training on instrumental activities after ischemic stroke. The intervention method is classified as an adaptive, intensive computerized working memory training program (Braining), developed by Professor Daniel Landinez Martinez at Universidad Católica Luis Amigo, Colombia. Both the adaptive and active control training groups will use the program approximately for 25 sessions of 50 minutes over 12 weeks.The training is considered adaptive which means that the difficulty level of the tasks increases during the sessions according to the individual level of mastering for each participant, making the patient work at their maximum capacity at all times. This is the core element of the hypothesized effectiveness of the intervention. The active control group will use a non-adaptive (fixed low-level training) version of the training program. The interface of both the active control and the training version is identical, but the difficulty level in the active control group version does not increase adaptively as the patient performance improves. The study involves two examinations at the following time points: baseline before training, retesting after training completion (3 months). Direct benefits include increasing functional independence: using a cellphone, taking his/her own medication, handling money, cooking, turn on/off the radio and T.V, walking around the house. Other indirect benefits include better quaility of life. 

This trial has been approved by both Universidad San Buenaventura Research Ethics Comittee and by Clinica San Marcel Institutional Review Board

Theory of Change:

The following activity:

Adaptive computer-based working memory training

Leads to:

ischemic stroke patients improving their performance in working memory tasks 

Which:

increases ischemic stroke patients performance in instrumental activities of daily living 

Resulting in: 

Higher levels of functional independence  

 

Multiple Treatment Arms Evaluated?
Yes

Implementing Agency

Name of Organization:
Universidad Católica Luis Amigo
Type of Organization:
Research Institution/University

Program Funder

Name of Organization:
Universidad Católica Luis Amigó
Type of Organization:
Research Institution/University

Intervention Timing

Intervention or Program Started at time of Registration?
No
Start Date:
02/10/2020
End Date:
06/15/2022
Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:
Randomized control trial
Other (not Listed) Method:
Additional Evaluation Method (If Any):
Other (not Listed) Method:

Method Details

Details of Evaluation Approach:

The proposed study is a randomized, controlled study that will include 54 patients diagnosed with ischemic stroke at a rehabilitation hospital. The participants will be randomized to either a training program or an active control group. The intervention is a computerized working memory training performed for 25 sessions of 50 minutes over 12 weeks. The active control group will train with an identical program in duration but is non-adaptive in the difficulty level of the tasks.The study involves two examinations at the following time points: baseline before training, retesting after training completion (3 months)

Key feasibility aims are to: 

1. Describe socio-demographic and clinical features of an ischemic stroke patients sample  

2. Measure performance in the Lawton-brody scale of instrumental activities of daily living  and the working memory index before and after working memory training 

3. Compare performance in the Lawton-brody scale of instrumental activities of daily living  and the working memory index before and after working memory training in a sample of ischemic stroke patients. 

Outcomes (Endpoints):

Primary outcome measure:  Lawton-Brody Instrumental Activities of Daily Living 

Secondary outcome measure:  Working memory index from the Wechsler Adult Intelligence Scale (WAIS-IV), Corsi block tapping test and the Working memory Questionnaire. 

Unit of Analysis:
ischemic stroke patients
Hypotheses:

An adaptive computer-based working memory training is effective in improving instrumental activities of daily living performance over time in patients diagnosed with ischemic stroke. 

Unit of Intervention or Assignment:
each ischemic stroke patient
Number of Clusters in Sample:
individual intervention
Number of Individuals in Sample:
54
Size of Treatment, Control, or Comparison Subsamples:
27 individuals in the adaptive working memory training and 27 individuals in the active control group, total 54

Supplementary Files

Analysis Plan:
Other Documents:
Data

Outcomes Data

Description:
Control and Intervention group: Socio-demographic interview, Montreal Cognitive Assessment, Yesavage geriatric depression scale, Lawton-Brody instrumental activities of daily living scale, Working memory index (Wechsler Adult Intelligence scale), Corsi Block Tapping test, Working memory Questionnaire.
Data Already Collected?
No
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Treatment Assignment Data

Participation or Assignment Information:
Yes
Description:
Data Obtained by the Study Researchers?
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

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Registration Category

Registration Category:
Prospective, Category 1: Data for measuring impacts have not been collected
Completion

Completion Overview

Intervention Completion Date:
Data Collection Completion Date:
Unit of Analysis:
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Total Observations in Final Sample:
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Findings

Preliminary Report:
Preliminary Report URL:
Summary of Findings:
Paper:
Paper Summary:
Paper Citation:

Data Availability

Data Availability (Primary Data):
Date of Data Availability:
Data URL or Contact:
Access procedure:

Other Materials

Survey:
Survey Instrument Links or Contact:
Program Files:
Program Files Links or Contact:
External Link:
External Link Description:
Description of Changes:

Study Stopped

Date:
Reason: