Cognitive FunctionNCT07250932
Exploring the Effectiveness of Somatosensory Cognitive Game Intervention on Cognitive and Physical Functions
A study testing somatosensory cognitive game in people with Cognitive Function, run by Taipei Medical University.
Trial summary
This study investigates the effects of somatosensory cognitive games interventions on older adults' cognitive and physical functions. The investigators plan to recruit up to 100 participants and randomly assign them to a control group or an experimental group. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- What is being tested?
- somatosensory cognitive game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Elderly individuals aged 65 and above.
- Able to communicate in Chinese (Mandarin or Taiwanese).
- Voluntarily participate in this study and sign a written consent form.
Who cannot join
- Individuals with severe visual impairments or physical mobility disabilities that prevent them from participating in the game activities designed in this study.
- Individuals diagnosed with severe dementia who are unable to understand or participate in the research process.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Exploring the Effectiveness of Somatosensory Cognitive Game Intervention on Cognitive and Physical Functions in Older Adults
This study investigates the effects of somatosensory cognitive games interventions on older adults' cognitive and physical functions. The investigators plan to recruit up to 100 participants and randomly assign them to a control group or an experimental group. The experimental group will participate in somatosensory cognitive games for 12 weeks, while the control group will receive routine care. Data will be collected via questionnaires to examine whether somatosensory cognitive games can delay declines in cognitive and physical functions in older adults.
Read the detailed description
This study investigates the effects of somatosensory cognitive games interventions on the cognitive and physical functions of older adults. The investigators plan to recruit 80 participants and randomly assign them to either a control group or an experimental group. The experimental group will participate in somatosensory cognitive games for 12 weeks, twice a week, about 30 minutes per session; the control group will receive usual care without any specific intervention. All participants will complete four questionnaire assessments to examine whether somatosensory cognitive games can slow decline in cognitive and physical functions.
- Conditions
- Cognitive Function
- Being tested
- somatosensory cognitive game
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatosensory cognitive gameOther
The experimental group will participate in somatosensory cognitive games for 12 weeks, twice a week, about 30 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| Somatosensory Cognitive Game Intervention on Cognitive and Physical | Experimental | Not described Receives: Other: somatosensory cognitive game |
| Routine care | No intervention | no Intervention on Cognitive and Physical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
MoCA is one of the key cognitive function outcomes that investigators expect to improve after somatosensory cognitive games. MoCA assesses six cognitive dimensions, with a total score of 30. A score of 26 or higher is considered normal. MoCA score of ≤24 may indicate a risk of mild cognitive impairment (MCI), while a MoCA score of ≤20 may indicate a risk of dementia.
Measured: 3 month follow-up
Color Trails Test (CTT)
CTT is one of the key cognitive function outcomes that investigators expect to improve after somatosensory cognitive games. CTT is widely used to assess executive function and processing speed. The first part (CTT-1) evaluates visual-motor skills and attention, while the second part of the CTT (CTT-2) assesses sequencing and cognitive flexibility. Scoring is based on the time required to complete the test, with cutoff times of 240 seconds for CTT-1 and 330 seconds for CTT-2. Shorter completion times indicate better executive function and processing speed.
Measured: 3 month follow-up
Secondary outcomes (2)
Short Physical Performance Battery (SPPB)
SPPB is another secondary outcome measure that researchers expect to improve after intervention with somatosensory cognitive games. SPPB is mainly used to assess the physical function and mobility of elderly people, with a total score range of 0-12 points, where higher scores indicate better physical function.
Measured: 3 month follow-up
Timed Up and Go Test (TUG)
TUG is another secondary outcome measure that researchers expect to improve after intervention with somatosensory cognitive games. TUG is an assessment tool for evaluating gait and mobility in elderly people. TUG < 10 seconds indicates normal mobility, TUG 11-20 seconds indicates those who can walk independently (but move more slowly), and TUG > 20 seconds indicates those who require assistive devices (such as walkers).
Measured: 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250932
- Sponsor's protocol ID
- N202509045
- Status last verified
- Sep 2025
- First submitted
- 13 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effectiveness of Somatosensory Cognitive Game Intervention on Cognitive and Physical Functions in Older Adults
- ClinicalTrials.gov ID
- NCT07250932
- Acronym / sponsor ID
- N202509045
- Conditions
- Cognitive Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Nov 2025 (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 study investigates the effects of somatosensory cognitive games interventions on older adults' cognitive and physical functions. The investigators plan to recruit up to 100 participants and randomly assign them to a control group or an experimental group. The experimental group will participate in somatosensory cognitive games for 12 weeks, while the control group will receive routine care. Data will be collected via questionnaires to examine whether somatosensory cognitive games can delay declines in cognitive and physical functions in older adults.
Detailed description
This study investigates the effects of somatosensory cognitive games interventions on the cognitive and physical functions of older adults. The investigators plan to recruit 80 participants and randomly assign them to either a control group or an experimental group. The experimental group will participate in somatosensory cognitive games for 12 weeks, twice a week, about 30 minutes per session; the control group will receive usual care without any specific intervention. All participants will complete four questionnaire assessments to examine whether somatosensory cognitive games can slow decline in cognitive and physical functions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Somatosensory Cognitive Game Intervention on Cognitive and Physical | Experimental | Other: somatosensory cognitive game |
| Routine care | No intervention | –no Intervention on Cognitive and Physical |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Elderly individuals aged 65 and above.
- Able to communicate in Chinese (Mandarin or Taiwanese).
- Voluntarily participate in this study and sign a written consent form.
Key exclusion criteria (2 listed)
- Individuals with severe visual impairments or physical mobility disabilities that prevent them from participating in the game activities designed in this study.
- Individuals diagnosed with severe dementia who are unable to understand or participate in the research process.
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 |
|---|---|---|
| somatosensory cognitive gameThe experimental group will participate in somatosensory cognitive games for 12 weeks, twice a week, about 30 minutes per session. | Other | Somatosensory Cognitive Game Intervention on Cognitive and Physical |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: 3 month follow-up
MoCA is one of the key cognitive function outcomes that investigators expect to improve after somatosensory cognitive games. MoCA assesses six cognitive dimensions, with a total score of 30. A score of 26 or higher is considered normal. MoCA score of ≤24 may indicate a risk of mild cognitive impairment (MCI), while a MoCA score of ≤20 may indicate a risk of dementia.
Color Trails Test (CTT)
Time frame: 3 month follow-up
CTT is one of the key cognitive function outcomes that investigators expect to improve after somatosensory cognitive games. CTT is widely used to assess executive function and processing speed. The first part (CTT-1) evaluates visual-motor skills and attention, while the second part of the CTT (CTT-2) assesses sequencing and cognitive flexibility. Scoring is based on the time required to complete the test, with cutoff times of 240 seconds for CTT-1 and 330 seconds for CTT-2. Shorter completion times indicate better executive function and processing speed.
2 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: 3 month follow-up
Timed Up and Go Test (TUG)
Time frame: 3 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing somatosensory cognitive game in people with Cognitive Function, run by Taipei Medical University.
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 2 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: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorothy Bai, PhD (+886-2-27361661 Ext. 6332, dbai@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) (time frame: 3 month follow-up). The study lists 2 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 26 Nov 2025.