AgingNCT04873843
The Impact of Multi-Touch Functional Digital Game on Intelligence and Vitality for the Community-dwelling Elderly
A study testing Functional digital game training group and Individual cognitive training in people with Aging, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This single-blinded, randomized, controlled trial includes 32 elderly. The participants were randomized to intervention(Happy Table) and control(cognitive stimulation activity) groups. Each group is divided in 16 participants. Read more about this study
- Who is it for?
- Ages 65 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Functional digital game training group and Individual cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Sep 2021to 4 Aug 2022
- 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 65 to 84 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- community-dwelling senior citizens aged 65 to 84
- Those without a history of central nervous system(CNS) disease
Who cannot join
- When it is difficult to understand the task performance due to severe cognitive decline(Korean Simple Mental State Test, K-MMSE 10 points or less).
- When it is difficult to use this game device due to problems such as decreased vision or fracture of the upper limb
- In case of accompanying serious mental illness
Trial locations and contacts
1 site in 1 country.
About this study
This single-blinded, randomized, controlled trial includes 32 elderly. The participants were randomized to intervention(Happy Table) and control(cognitive stimulation activity) groups. Each group is divided in 16 participants. In one session, participants in the Happy Table group completed 40 minutes of intervention using Happy Table serious game, whereas those in the Control group completed 40 minutes of cognitive stimulation game.
Read the detailed description
At the first visit, the subjects are fully informed of the study if appropriate after determining whether they meet the selection criteria. This single-blinded, randomized, controlled trial includes 32 elderly. The participants were randomized to intervention(Happy Table) and control(cognitive stimulation activity) groups. Each group is divided in 16 participants. In one session, participants in the Happy Table group completed 40 minutes of intervention using Happy Table serious game, whereas those in the Control group completed 40 minutes of cognitive stimulation game.
- Conditions
- Aging
- Being tested
- Functional digital game training group, Individual cognitive training
- Keywords
- Elderly, Functional Digital Game, Multi-touch Game, Intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional digital game training groupBehavioural
Functional digital game training group is divided in 16 participants. In one session, participants in the functional digital game training group completed 40 minutes of intervention using various functional digital game such as working memory, memory, and attention. (Total 10 session)
Individual cognitive trainingBehavioural
Functional digital game training group is divided in 16 participants. In one session, participants in the individual cognitive training group completed 40 minutes of intervention using various cognitive training such as working memory, memory, and attention. (Total 10 session)
| Study group | Role | What they receive |
|---|---|---|
| Functional digital game training group | Experimental | These functional digital game programs have been developed to improve the intelligence and vitality in the community-dwelling elderly. The program includes sub-categories such as attention, working memory, memory and executive functions with various levels of difficulty. Receives: Behavioral: Functional digital game training group |
| Individual cognitive training | Experimental | Individual cognitive training has been used to improve the intelligence and cognitive function in community-dwelling elderly. The program includes sub-categories such as attention, working memory, memory and executive functions with various levels of difficulty. Receives: Behavioral: Individual cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline performance on Stroop test (Neuropsychological test) after the intervention (Day 13).
It measures a participant's processing speed, selective attention and inhibitory control. The participant will be asked to read 'word' of the colored words or 'name of the color' of the colored words in separate trials. The main scores produced in this test are completion time and errors. The contrast score of the two trial's completion time means interference.
Measured: Baseline, After the intervention (Day 13)
Secondary outcomes (12)
Change from baseline performance on Fluency Test (Neuropsychological test) after the intervention (Day 13).
This is a generative naming test. That measure how many words you can spontaneously speak within a limited time of words that fall into a specific category (e.g. animals, store goods, vegetables) or words starting with a letter (e.g. F • A • S or C·F·L).
Measured: Baseline, After the intervention (Day 13)
Change from baseline performance on Trail Making Test (Neuropsychological test) after the intervention (Day 13).
It consists of type A and type B trials. The participant should connect the numbers (1~25) as quickly as possible in Type A trial, and connect the numbers (1~13) and alphabets (A~L) alternatively as quickly as possible in type B trial. The main scores produced in this test are completion time and errors. Higher score means worse performance.
Measured: Baseline, After the intervention (Day 13)
Change from baseline performance on Digit Span Test (Neuropsychological test) after the intervention (Day 13).
It measures auditory attention span and includes forward and backward trials. The participant listens to a series of numbers and calls the sequence correctly. The sequence increases in each trial. The final score is the longest number of sequential digits that the participant can remember correctly. The scores range from 3 to 8. The higher the score, the better the performance.
Measured: Baseline, After the intervention (Day 13)
Change from baseline performance on Auditory Verbal Learning test (Neuropsychological test) after the intervention (Day 13).
It measures participant's verbal memory. The participant will hear 15 words and recall them immediately and after 20 minutes again. The main scores produced in this test are the numbers of recalled words of the immediate and delayed trials. Immediate memory score is the sum of 5 trial's correct response and score ranges between 0 and 60. Delayed memory score is the correct response of the delayed trial and the score range is 0 to 15. Higher score means better performance.
Measured: Baseline, After the intervention (Day 13)
Change from baseline activity on functional Near-Infrared Spectroscopy (fNIRS) during the intervention(Day 1 and 12)and after intervention completion(Day 12)
It measures brain activity during cognitive tasks to see if cognitive training affects brain function.
Measured: Baseline, during the intervention(Day 1 and 12), Through intervention completion(Day 12)
Change from baseline activity on Contrasting Program/Go-No-Go test after the intervention (Day 13).
The Contrasting Program and go-no go test requires a subject to emit a simple motor response to one cue while inhibiting the response in the presence of another cue. This test has been effective in demonstrating impulsivity (elevated commission error rate) in elderly with attention deficit.
Measured: Baseline, Day 13(After the intervention)
Change from baseline activity on Geriatric Depression Scale (GDS) after the intervention (Day 13).
GDS is a 15-item self-report assessment used to identify depression in the elderly. A score of 0 to 5 is normal. A score greater than 5 suggests depression
Measured: Baseline, After the intervention (Day 13)
Change from baseline activity on health-related quality of life instrument with 20 items (HINT-20) after the intervention (Day 13).
The total score of the HINT-20 is converted to a 0-100 scale, with higher scores indicating better health-related quality of life.
Measured: Baseline, After the intervention (Day 13)
Change from baseline activity on General Self-Efficacy Scale (GSE) after the intervention (Day 13).
General self-efficacy (GSE), individuals'belief in their ability to perform well in a variety of situations. General self-efficacy (GSE) is the belief in one's competence to attempt difficult or novel tasks, and to cope with adversity arising from specific demanding situations.
Measured: Baseline, After the intervention (Day 13)
Change from baseline activity on International Physical Activity Questionnaire after the intervention (Day 13).
Physical Activity Questionnaire collects information on physical activity participation in three settings (or domains) as well as sedentary behaviour, comprising 16 questions.
Measured: Baseline, After the intervention (Day 13)
User Satisfaction Questionnaire after intervention.
We evaluate the satisfaction questionnaire for each training.
Measured: After the intervention (Day 13)
Change from baseline activity on smart band activity through intervention completion(Day 12).
Each participant was given an smart band(number of steps count) and instructed to wear it on the wrist during waking hours until completion of the training program. This included both intervening training days (totaling 10).
Measured: Baseline, through intervention completion(Day 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start16 Sep 2021
- Primary completion21 Feb 2022
- Study completion4 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun-hee Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873843
- Sponsor's protocol ID
- 2021-03-011
- Status last verified
- Apr 2021
- First submitted
- 5 Apr 2021
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Multi-Touch Functional Digital Game on Intelligence and Vitality for the Community-dwelling Elderly
- ClinicalTrials.gov ID
- NCT04873843
- Acronym / sponsor ID
- 2021-03-011
- Conditions
- Aging
- Keywords
- Elderly, Functional Digital Game, Multi-touch Game, Intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 4 Aug 2022 (actual)
- First posted
- 5 May 2021 (actual)
- 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.
This single-blinded, randomized, controlled trial includes 32 elderly. The participants were randomized to intervention(Happy Table) and control(cognitive stimulation activity) groups. Each group is divided in 16 participants. In one session, participants in the Happy Table group completed 40 minutes of intervention using Happy Table serious game, whereas those in the Control group completed 40 minutes of cognitive stimulation game.
Detailed description
At the first visit, the subjects are fully informed of the study if appropriate after determining whether they meet the selection criteria. This single-blinded, randomized, controlled trial includes 32 elderly. The participants were randomized to intervention(Happy Table) and control(cognitive stimulation activity) groups. Each group is divided in 16 participants. In one session, participants in the Happy Table group completed 40 minutes of intervention using Happy Table serious game, whereas those in the Control group completed 40 minutes of cognitive stimulation game.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional digital game training group | Experimental | Behavioral: Functional digital game training groupThese functional digital game programs have been developed to improve the intelligence and vitality in the community-dwelling elderly. The program includes sub-categories such as attention, working memory, memory and executive functions with various levels of difficulty. |
| Individual cognitive training | Experimental | Behavioral: Individual cognitive trainingIndividual cognitive training has been used to improve the intelligence and cognitive function in community-dwelling elderly. The program includes sub-categories such as attention, working memory, memory and executive functions with various levels of difficulty. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- community-dwelling senior citizens aged 65 to 84
- Those without a history of central nervous system(CNS) disease
Key exclusion criteria (3 listed)
- When it is difficult to understand the task performance due to severe cognitive decline(Korean Simple Mental State Test, K-MMSE 10 points or less).
- When it is difficult to use this game device due to problems such as decreased vision or fracture of the upper limb
- In case of accompanying serious mental illness
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 |
|---|---|---|
| Functional digital game training groupFunctional digital game training group is divided in 16 participants. In one session, participants in the functional digital game training group completed 40 minutes of intervention using various functional digital game such as working memory, memory, and attention. (Total 10 session) | Behavioural | Functional digital game training group |
| Individual cognitive trainingFunctional digital game training group is divided in 16 participants. In one session, participants in the individual cognitive training group completed 40 minutes of intervention using various cognitive training such as working memory, memory, and attention. (Total 10 session) | Behavioural | Individual cognitive training |
Primary outcome
Change from baseline performance on Stroop test (Neuropsychological test) after the intervention (Day 13).
Time frame: Baseline, After the intervention (Day 13)
It measures a participant's processing speed, selective attention and inhibitory control. The participant will be asked to read 'word' of the colored words or 'name of the color' of the colored words in separate trials. The main scores produced in this test are completion time and errors. The contrast score of the two trial's completion time means interference.
12 secondary outcomes
Change from baseline performance on Fluency Test (Neuropsychological test) after the intervention (Day 13).
Time frame: Baseline, After the intervention (Day 13)
Change from baseline performance on Trail Making Test (Neuropsychological test) after the intervention (Day 13).
Time frame: Baseline, After the intervention (Day 13)
Change from baseline performance on Digit Span Test (Neuropsychological test) after the intervention (Day 13).
Time frame: Baseline, After the intervention (Day 13)
Change from baseline performance on Auditory Verbal Learning test (Neuropsychological test) after the intervention (Day 13).
Time frame: Baseline, After the intervention (Day 13)
Change from baseline activity on functional Near-Infrared Spectroscopy (fNIRS) during the intervention(Day 1 and 12)and after intervention completion(Day 12)
Time frame: Baseline, during the intervention(Day 1 and 12), Through intervention completion(Day 12)
Change from baseline activity on Contrasting Program/Go-No-Go test after the intervention (Day 13).
Time frame: Baseline, Day 13(After the intervention)
Change from baseline activity on Geriatric Depression Scale (GDS) after the intervention (Day 13).
Time frame: Baseline, After the intervention (Day 13)
Change from baseline activity on health-related quality of life instrument with 20 items (HINT-20) after the intervention (Day 13).
Time frame: Baseline, After the intervention (Day 13)
Change from baseline activity on General Self-Efficacy Scale (GSE) after the intervention (Day 13).
Time frame: Baseline, After the intervention (Day 13)
Change from baseline activity on International Physical Activity Questionnaire after the intervention (Day 13).
Time frame: Baseline, After the intervention (Day 13)
User Satisfaction Questionnaire after intervention.
Time frame: After the intervention (Day 13)
Change from baseline activity on smart band activity through intervention completion(Day 12).
Time frame: Baseline, through intervention completion(Day 12)
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 22 Sep 2022.
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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.
Yun-hee Kim, 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 Functional digital game training group and Individual cognitive training in people with Aging, 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 2 inclusion and 3 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 22 Sep 2022. 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?
Change from baseline performance on Stroop test (Neuropsychological test) after the intervention (Day 13). (time frame: Baseline, After the intervention (Day 13)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2022.