Age-Related Cognitive DeclineNCT01596205
The Efficacy of Robot Assisted Group Cognitive Training in Elderly Adults Without Cognitive Impairment
A study testing Robot assisted cognitive training and Conventional cognitive training group in people with Age-Related Cognitive Decline, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Cognitive Decline
- What is being tested?
- Robot assisted cognitive training and Conventional cognitive training group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- community-dwelling volunteers aged 60 years or older
- without dementia
- MMSE=26 or above
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Age-Related Cognitive Decline
- Being tested
- Robot assisted cognitive training, Conventional cognitive training group
- Keywords
- cognitive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot assisted cognitive trainingBehavioural
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.
Conventional cognitive training groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Robot intervention | Experimental | 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. Receives: Behavioral: Robot assisted cognitive training |
| Conventional intervention | Active comparator | conventional cognitive training group - pen and pencil with experienced behavioral therapists Receives: Behavioral: Conventional cognitive training group |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between the baseline and the post-intervention assessment (12 week training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Related Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duk L. Na, MD,PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596205
- Sponsor's protocol ID
- 2011-04-080
- Status last verified
- May 2012
- First submitted
- 9 May 2012
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25898367
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Robot Assisted Group Cognitive Training in Elderly Adults Without Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01596205
- Acronym / sponsor ID
- 2011-04-080
- Conditions
- Age-Related Cognitive Decline
- Keywords
- cognitive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Robot intervention | Experimental | Behavioral: Robot assisted cognitive trainingParticipants 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 comparator | Behavioral: Conventional cognitive training groupconventional cognitive training group - pen and pencil with experienced behavioral therapists |
| Control group | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- community-dwelling volunteers aged 60 years or older
- without dementia
- MMSE=26 or above
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot assisted cognitive trainingWe 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. | Behavioural | Robot intervention |
| Conventional cognitive training groupExperienced 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. | Behavioural | Conventional intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
- Derived from this study: PubMed 25898367Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duk L. Na, MD,PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot assisted cognitive training and Conventional cognitive training group in people with Age-Related Cognitive Decline, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01596205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2012.