- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07250932
Exploring the Effectiveness of Somatosensory Cognitive Game Intervention on Cognitive and Physical Functions
November 18, 2025 updated by: Taipei Medical University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dorothy Bai, PhD
- Phone Number: +886-2-27361661 Ext. 6332
- Email: dbai@tmu.edu.tw
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Somatosensory Cognitive Game Intervention on Cognitive and Physical
|
The experimental group will participate in somatosensory cognitive games for 12 weeks, twice a week, about 30 minutes per session.
|
|
No Intervention: Routine care
no Intervention on Cognitive and Physical
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 month follow-up
|
|
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.
|
3 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Physical Performance Battery (SPPB)
Time Frame: 3 month follow-up
|
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.
|
3 month follow-up
|
|
Timed Up and Go Test (TUG)
Time Frame: 3 month follow-up
|
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).
|
3 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
November 13, 2025
First Submitted That Met QC Criteria
November 18, 2025
First Posted (Actual)
November 26, 2025
Study Record Updates
Last Update Posted (Actual)
November 26, 2025
Last Update Submitted That Met QC Criteria
November 18, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- N202509045
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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