The Efficacy of Robot Assisted Group Cognitive Training in Elderly Adults Without Cognitive Impairment

May 9, 2012 updated by: Samsung Medical Center

Previous studies about cognitive intervention targeting older adults revealed that cognitive training had effects on the improvement of cognitive function.However, researches are rare that investigated direct changes of brain structures after cognitive training.

The advanced scientific technique allowed us to develop service robots designed to assist human work, which can be important with an increase in the aging population and high costs of elderly care. In this regard, the investigators considered robots for elderly's cognitive training and developed 17 cognitive programs in collaboration with Center for Intelligent Robotics at Korea Institute of Science and Technology.

The purposes of this study were to demonstrate the effects of the investigators newly developed robot assisted group cognitive training programs on the brain in older adults and to identify whether they can help to improve cognitive function or mood in the elderly compared to the conventional cognitive training or control group that were not involved in any cognitive training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary outcome The primary outcome of this study was the change in cortical thickness between the baseline and the post-intervention assessment.

Secondary outcomes Change in the brain functional network from the baseline to the postintervention assessment was also assessed as a secondary outcome ascertained by the analysis of resting state fMRI, which has been used to show correlated spontaneous activity within cortical and subcortical regions that are functionally related.

Further secondary outcomes were changes between the baseline and the post-intervention assessment on cognitive function measured by validated neuropsychological tests such as SNSB and CANTAB on participants' depressive and anxiety symptoms scored by Geriatric Depression Scale and Geriatric Anxiety Inventory respectively, on self reported memory problems measured by Korean Dementia Screenng Questionnaire, Multifactorial Memory Questionnaire and Prospective and Retrospective Memory Questionnaire, on functions of daily living acitivity measured by Bayer ADL, on quality of life measuared by WHOQOL-bref.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • community-dwelling volunteers aged 60 years or older
  • without dementia
  • MMSE=26 or above

Exclusion Criteria:

  • if they had known dementia or significant cognitive impairment accompanied by dysfunction of daily living activities;
  • had 6 years of education or under;
  • were illiterate
  • were unavailable during the testing and intervention periods of the study;
  • had severe losses in vision or hearing; had major neurological or psychiatric illness history including any history of stroke, transient ischemic attack or traumatic brain injury;
  • had a medication history which might affect on cognitive function such as acetylcholinesterase inhibitor or memantine
  • had medical problems such as thyroid, liver and renal disease;
  • had a significan structural abnormalities on their baseline brain MRI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Robot intervention
Participants were given baseline assessments and randomly assigned into 3 groups; 24 with robot assisted cognitive training group (Robot intervention group), 24 with experienced behavioral therapist group (Conventional intervention group), and 37 without cognitive training (Control group).It was explained that there was a waiting list, therefore, participants in control group had an opportunity to participate in cognitive training program after a delay of 12 weeks for the intervention.
Behavioral: Robot assisted cognitive training
We developed total 17 software programs for cognitive training with robot which were intended to develop for improvement of following cognitive function;5 programs for memory, 2 for language , 1 for reasoning, 3 for working memory or speed of processing, 2 for calculation and 4 for visuospatial function.
Active Comparator: Conventional intervention
conventional cognitive training group - pen and pencil with experienced behavioral therapists
Behavioral: Conventional cognitive training group

Experienced behavioral therapists who had been clinical neuropsychologists for 2 years instructed the participants in cognitive training. Thearpists were familiarized with manuals for cognitive training before study inception, and were instructed to adhere to the manual but were allowed to distribute time flexibly among the programs in the same cognitive domain.

In all sessions of conventional intervention group, the behavioral therapists showed several questions or instructions on the screen and then the participants answered to the questions with verbal or written words using paper and pencil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change in cortical thickness between the baseline and the post-intervention assessment.
Time Frame: between the baseline and the post-intervention assessment (12 week training)
The primary outcome of this study was the change in cortical thickness between the baseline and the post-intervention assessment.
between the baseline and the post-intervention assessment (12 week training)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Duk L. Na, MD,PhD, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

May 9, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (Estimate)

May 10, 2012

Study Record Updates

Last Update Posted (Estimate)

May 10, 2012

Last Update Submitted That Met QC Criteria

May 9, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-04-080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Age-Related Cognitive Decline

Clinical Trials on Robot assisted cognitive training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe