The Efficacy of Robot Assisted Group Cognitive Training in Elderly Adults Without Cognitive Impairment
1 other identifier
interventional
85
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 9, 2012
CompletedFirst Posted
Study publicly available on registry
May 10, 2012
CompletedMay 10, 2012
May 1, 2012
8 months
May 9, 2012
May 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the change in cortical thickness between the baseline and the post-intervention assessment.
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)
Study Arms (3)
Robot intervention
EXPERIMENTALParticipants 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.
Conventional intervention
ACTIVE COMPARATORconventional cognitive training group - pen and pencil with experienced behavioral therapists
Control group
NO INTERVENTIONInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- community-dwelling volunteers aged 60 years or older
- without dementia
- MMSE=26 or above
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
Related Publications (1)
Kim GH, Jeon S, Im K, Kwon H, Lee BH, Kim GY, Jeong H, Han NE, Seo SW, Cho H, Noh Y, Park SE, Kim H, Hwang JW, Yoon CW, Kim HJ, Ye BS, Chin JH, Kim JH, Suh MK, Lee JM, Kim ST, Choi MT, Kim MS, Heilman KM, Jeong JH, Na DL. Structural brain changes after traditional and robot-assisted multi-domain cognitive training in community-dwelling healthy elderly. PLoS One. 2015 Apr 21;10(4):e0123251. doi: 10.1371/journal.pone.0123251. eCollection 2015.
PMID: 25898367DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Duk L. Na, MD,PhD
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2012
First Posted
May 10, 2012
Study Start
June 1, 2011
Primary Completion
February 1, 2012
Study Completion
May 1, 2012
Last Updated
May 10, 2012
Record last verified: 2012-05