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

Primary Purpose

Age-Related Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Robot assisted cognitive training
Conventional cognitive training group
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Age-Related Cognitive Decline focused on measuring cognitive therapy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Robot intervention

Conventional intervention

Control group

Arm Description

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.

conventional cognitive training group - pen and pencil with experienced behavioral therapists

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2012
Last Updated
May 9, 2012
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01596205
Brief Title
The Efficacy of Robot Assisted Group Cognitive Training in Elderly Adults Without Cognitive Impairment
Official Title
The Efficacy of Robot Assisted Group Cognitive Training in Elderly Adults Without Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Cognitive Decline
Keywords
cognitive therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional intervention
Arm Type
Active Comparator
Arm Description
conventional cognitive training group - pen and pencil with experienced behavioral therapists
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Robot assisted cognitive training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional cognitive training group
Intervention Description
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.
Primary Outcome Measure Information:
Title
the change in cortical thickness between the baseline and the post-intervention assessment.
Description
The primary outcome of this study was 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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duk L. Na, MD,PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25898367
Citation
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.
Results Reference
derived

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

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