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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01596205
First received: May 9, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Age-Related Cognitive Decline
Behavioral: Robot assisted cognitive training
Behavioral: Conventional cognitive training group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of Robot Assisted Group Cognitive Training in Elderly Adults Without Cognitive Impairment

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    The primary outcome of this study was the change in cortical thickness between the baseline and the post-intervention assessment.


Enrollment: 85
Study Start Date: June 2011
Study Completion Date: May 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

No Intervention: Control group

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596205

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Duk L. Na, MD,PhD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01596205     History of Changes
Other Study ID Numbers: 2011-04-080
Study First Received: May 9, 2012
Last Updated: May 9, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
cognitive therapy

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014