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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Elderly individuals aged 65 and above.
  2. Able to communicate in Chinese (Mandarin or Taiwanese).
  3. Voluntarily participate in this study and sign a written consent form.

Exclusion Criteria:

  1. Individuals with severe visual impairments or physical mobility disabilities that prevent them from participating in the game activities designed in this study.
  2. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Somatosensory Cognitive Game Intervention on Cognitive and Physical
Other: somatosensory cognitive game
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings