AgingNCT03940079
Efficacy of Computer-Based Cognitive Game Training for Healthy Elderly
A study testing computer-based cognitive game (including 3 training tasks) in people with Aging and Cognitive Function, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The declination on cognitive and motor functions in older adults increases the difficulty to achieve successful aging. Previous studies had reported that contrast to the traditional cognitive training methods, computer cognitive training (CCT) is comparable or has better effect on the cognitive function improvement… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Function
- What is being tested?
- computer-based cognitive game (including 3 training tasks)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2018to 27 Jun 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ≥ 65 years old
- Montreal Cognitive Assessment (MoCA) score ≥ 18
- clear eyesight and hearing
- both upper and lower limbs are functional
- normal communication
Who cannot join
- injury, fracture, and breathing problem
- surgery during the research
- severe disease affecting cognitive functions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Computer-Based Cognitive Game Training on Motor and Cognitive Functions for Healthy Elderly
The declination on cognitive and motor functions in older adults increases the difficulty to achieve successful aging. Previous studies had reported that contrast to the traditional cognitive training methods, computer cognitive training (CCT) is comparable or has better effect on the cognitive function improvement with elders.On the other hand, some researchers claimed motor-cognitive dual-task training may possess greater effects than single cognitive training on cognitive functions. However, it is still on debate. Therefore, the research aims to investigate cognitive and motor benefits to healthy older adults over 65s trained by our computer-based cognitive game with high and low level of motor engagements.The research questions include: (1) Is CCT beneficial of cognitive functions? (2) Does CCT with high level of motor engagements (i.e. motor-cognitive dual-task training) have greater effects than single cognitive training on cognitive functions? (3) Can the training effect remain?
Read the detailed description
Quasi-experimental design was adapted in our research.There are four time-series assessments during the experiment: baseline, pretest, posttest, and follow-up. After the baseline assessment, participants were randomized to two groups: gross-motor group (GMG) and fine-motor group (FMG). The intervals between baseline and pretest as well as between pretest and posttest were both 4 weeks, while the interval between posttest and follow-up was 8 weeks.
The investigators developed a computer-based cognitive game and compared the efficacy of cognitive and motor functions between computer-based cognitive game combining two different demands on motor control. Investigators hypothesized: All participants who take part in the computer-based cognitive game training don't have learning effects on pretest and are able to improve cognitive functions including short-term memory, divided attention and inhibitory function after intervention; Gross-motor group make more progress than fine-motor group on cognitive and motor functions after intervention. Furthermore, gross-motor group maintained more training effect over cognitive and motor functions at follow-up than fine-motor group.
- Conditions
- Aging, Cognitive Function
- Being tested
- computer-based cognitive game (including 3 training tasks)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer-based cognitive game (including 3 training tasks)Device
First task was short-term memory training. Participants were instructed to memorize different colored circles with ordinal numbers which would disappear later. They triggered correct colored sensor in sequence according to their memory.
Second task was divided attention training. Different colored circles with ordinal numbers would not disappear this time.The participants should trigger correct colored sensor according to their sequence.
Third task was inhibitory function training. There were red and green lights, just like the traffic light, hung up at the upper left of the scene. Red light represented prohibition of triggering the colored sensor, while green light urged to trigger it. Yellow, red, blue and green circles showed up randomly and moved toward the beige region. When the circle came extremely closer to the beige region, the traffic light was randomized to lighten up red or green.The participants should judge and trigger the correct colored sensor.
| Study group | Role | What they receive |
|---|---|---|
| gross-motor group (GMG) | Experimental | The participants of GMG received motor-cognitive dual-task training. The sensors used by the participants were four different colored buttons. The participants wear a suit with two buttons on the shoulders and the other two fasten on the knees by velcros. To accomplish the tasks, the participants had to slap the correct colored buttons. The stretching of upper or lower limbs was demanding while slapping, so the participants of GMG received a training which required cognitive and motor functions at the same time.
The participants attended 2 sessions per week and lasted for 4 weeks. Each session lasted 75 minutes, mainly including 30 minutes for game introduction and warm-up, 30 minutes for game training, and 15 minutes for rest during the training. Each task lasted 10 minutes, and each session contained 3 tasks. The game difficulty could be adjusted automatically according to the performance of participants. Receives: Device: computer-based cognitive game (including 3 training tasks) |
| fine-motor group (FMG) | Active comparator | The participants of FMG received cognitive training only. Four colored sensors used by the participants were the keys on the keyboard of the laptop. The participants simply pressed correct colored keys by fingers to complete the tasks.
The participants attended 2 sessions per week and lasted for 4 weeks. Each session lasted 75 minutes, mainly including 30 minutes for game introduction and warm-up, 30 minutes for game training, and 15 minutes for rest during the training. Each task lasted 10 minutes, and each session contained 3 tasks. The game difficulty could be adjusted automatically according to the performance of participants. Receives: Device: computer-based cognitive game (including 3 training tasks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Montreal Cognitive Assessment (MoCA) Taiwan Version at the 4th, 8th and 16th weeks
overall cognitive function
Measured: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
Change from Baseline Digit Span Task-forward (DS-forward) at the 4th, 8th and 16th weeks
short-term memory
Measured: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
Change from Baseline Color Trails Test-2 (CTT-2) at the 4th, 8th and 16th weeks
divided attention
Measured: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
Change from Baseline Stroop Color Word Test (SCWT) at the 4th, 8th and 16th weeks
inhibitory function
Measured: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
Change from Baseline Nine Hole Peg Test (NHPT) at the 4th, 8th and 16th weeks
motor function of upper limbs
Measured: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
Change from Baseline Get-Up and Go Test (GUG) at the 4th, 8th and 16th weeks
motor function of lower limbs and balance
Measured: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
Change from Baseline Five-Times-Sit-to-Stand Test (FTSST) at the 4th, 8th and 16th weeks
motor function of lower limbs and balance
Measured: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
Secondary outcomes (3)
Change from 4th weeks Game1 (first scenario) evaluated the performance of short-term memory at 8th weeks
Game assessment was a new way to evaluate cognitive performance of the participant through the score. All participants proceeded all three scenarios but challenged same degree of difficulty.
Measured: 4th weeks pretest, 8th weeks posttest
Change from 4th weeks Game2 (second scenario) evaluated divided attention at 8th weeks
Game assessment was a new way to evaluate cognitive performance of the participant through the score. All participants proceeded all three scenarios but challenged same degree of difficulty.
Measured: 4th weeks pretest, 8th weeks posttest
Change from 4th weeks Game3 (third scenario) evaluated inhibitory function at 8th weeks
Game assessment was a new way to evaluate cognitive performance of the participant through the score. All participants proceeded all three scenarios but challenged same degree of difficulty.
Measured: 4th weeks pretest, 8th weeks posttest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 May 2018
- Primary completion27 Jun 2018
- Study completion27 Jun 2018
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 National Taiwan University HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Central Contact Backup Mao, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940079
- Sponsor's protocol ID
- 201804055RINC
- Status last verified
- Aug 2020
- First submitted
- 5 May 2019
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Computer-Based Cognitive Game Training on Motor and Cognitive Functions for Healthy Elderly
- ClinicalTrials.gov ID
- NCT03940079
- Acronym / sponsor ID
- 201804055RINC
- Conditions
- Aging, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 27 Jun 2018 (actual)
- Study completion
- 27 Jun 2018 (actual)
- First posted
- 7 May 2019 (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.
The declination on cognitive and motor functions in older adults increases the difficulty to achieve successful aging. Previous studies had reported that contrast to the traditional cognitive training methods, computer cognitive training (CCT) is comparable or has better effect on the cognitive function improvement with elders.On the other hand, some researchers claimed motor-cognitive dual-task training may possess greater effects than single cognitive training on cognitive functions. However, it is still on debate. Therefore, the research aims to investigate cognitive and motor benefits to healthy older adults over 65s trained by our computer-based cognitive game with high and low level of motor engagements.The research questions include: (1) Is CCT beneficial of cognitive functions? (2) Does CCT with high level of motor engagements (i.e. motor-cognitive dual-task training) have greater effects than single cognitive training on cognitive functions? (3) Can the training effect remain?
Detailed description
Quasi-experimental design was adapted in our research.There are four time-series assessments during the experiment: baseline, pretest, posttest, and follow-up. After the baseline assessment, participants were randomized to two groups: gross-motor group (GMG) and fine-motor group (FMG). The intervals between baseline and pretest as well as between pretest and posttest were both 4 weeks, while the interval between posttest and follow-up was 8 weeks.
The investigators developed a computer-based cognitive game and compared the efficacy of cognitive and motor functions between computer-based cognitive game combining two different demands on motor control. Investigators hypothesized: All participants who take part in the computer-based cognitive game training don't have learning effects on pretest and are able to improve cognitive functions including short-term memory, divided attention and inhibitory function after intervention; Gross-motor group make more progress than fine-motor group on cognitive and motor functions after intervention. Furthermore, gross-motor group maintained more training effect over cognitive and motor functions at follow-up than fine-motor group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gross-motor group (GMG) | Experimental | Device: computer-based cognitive game (including 3 training tasks)The participants of GMG received motor-cognitive dual-task training. The sensors used by the participants were four different colored buttons. The participants wear a suit with two buttons on the shoulders and the other two fasten on the knees by velcros. To accomplish the tasks, the participants had to slap the correct colored buttons. The stretching of upper or lower limbs was demanding while slapping, so the participants of GMG received a training which required cognitive and motor functions at the same time. The participants attended 2 sessions per week and lasted for 4 weeks. Each session lasted 75 minutes, mainly including 30 minutes for game introduction and warm-up, 30 minutes for game training, and 15 minutes for rest during the training. Each task lasted 10 minutes, and each session contained 3 tasks. The game difficulty could be adjusted automatically according to the performance of participants. |
| fine-motor group (FMG) | Active comparator | Device: computer-based cognitive game (including 3 training tasks)The participants of FMG received cognitive training only. Four colored sensors used by the participants were the keys on the keyboard of the laptop. The participants simply pressed correct colored keys by fingers to complete the tasks. The participants attended 2 sessions per week and lasted for 4 weeks. Each session lasted 75 minutes, mainly including 30 minutes for game introduction and warm-up, 30 minutes for game training, and 15 minutes for rest during the training. Each task lasted 10 minutes, and each session contained 3 tasks. The game difficulty could be adjusted automatically according to the performance of participants. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- ≥ 65 years old
- Montreal Cognitive Assessment (MoCA) score ≥ 18
- clear eyesight and hearing
- both upper and lower limbs are functional
- normal communication
Key exclusion criteria (3 listed)
- injury, fracture, and breathing problem
- surgery during the research
- severe disease affecting cognitive functions.
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 |
|---|---|---|
| computer-based cognitive game (including 3 training tasks)First task was short-term memory training. Participants were instructed to memorize different colored circles with ordinal numbers which would disappear later. They triggered correct colored sensor in sequence according to their memory. Second task was divided attention training. Different colored circles with ordinal numbers would not disappear this time.The participants should trigger correct colored sensor according to their sequence. Third task was inhibitory function training. There were red and green lights, just like the traffic light, hung up at the upper left of the scene. Red light represented prohibition of triggering the colored sensor, while green light urged to trigger it. Yellow, red, blue and green circles showed up randomly and moved toward the beige region. When the circle came extremely closer to the beige region, the traffic light was randomized to lighten up red or green.The participants should judge and trigger the correct colored sensor. | Device | fine-motor group (FMG), gross-motor group (GMG) |
Primary outcome
Change from Baseline Montreal Cognitive Assessment (MoCA) Taiwan Version at the 4th, 8th and 16th weeks
Time frame: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
overall cognitive function
Change from Baseline Digit Span Task-forward (DS-forward) at the 4th, 8th and 16th weeks
Time frame: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
short-term memory
Change from Baseline Color Trails Test-2 (CTT-2) at the 4th, 8th and 16th weeks
Time frame: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
divided attention
Change from Baseline Stroop Color Word Test (SCWT) at the 4th, 8th and 16th weeks
Time frame: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
inhibitory function
Change from Baseline Nine Hole Peg Test (NHPT) at the 4th, 8th and 16th weeks
Time frame: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
motor function of upper limbs
Change from Baseline Get-Up and Go Test (GUG) at the 4th, 8th and 16th weeks
Time frame: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
motor function of lower limbs and balance
Change from Baseline Five-Times-Sit-to-Stand Test (FTSST) at the 4th, 8th and 16th weeks
Time frame: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
motor function of lower limbs and balance
3 secondary outcomes
Change from 4th weeks Game1 (first scenario) evaluated the performance of short-term memory at 8th weeks
Time frame: 4th weeks pretest, 8th weeks posttest
Change from 4th weeks Game2 (second scenario) evaluated divided attention at 8th weeks
Time frame: 4th weeks pretest, 8th weeks posttest
Change from 4th weeks Game3 (third scenario) evaluated inhibitory function at 8th weeks
Time frame: 4th weeks pretest, 8th weeks posttest
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 11 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Central Contact Backup Mao principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computer-based cognitive game (including 3 training tasks) in people with Aging and Cognitive Function, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 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 11 Aug 2020. 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 Taiwan. 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 Montreal Cognitive Assessment (MoCA) Taiwan Version at the 4th, 8th and 16th weeks (time frame: baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up). The study lists 7 primary outcomes in all. 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 11 Aug 2020; AzTrials last refreshed its copy on 31 Oct 2026.