- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07315724
The Efficacy of a Technology-Assisted Block Training Program on Cognitive Function, Hand Dexterity, and Grip Strength in Community-Dwelling Older Adults: A Mixed-Methods Research
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chia-Jung Hsieh Professor, PhD
- Phone Number: Ext. 3135 886(2)2822-7101
- Email: chiajung@ntunhs.edu.tw
Study Contact Backup
- Name: Yu-Ling Chen NP, PHD student
- Phone Number: Ext. 3135 886(2)2822-7101
- Email: vicky531366@gmail.com
Study Locations
-
-
Taiwan
-
Yilan, Taiwan, Taiwan, 260
- Recruiting
- Xindong Community Activity Center, Yilan City
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 65 and older
- Mentally alert and able to communicate
- Willing to participate in this study
Exclusion Criteria:
- Diagnosed with dementia by a physician
- Severe sensory or communication impairment
- Hand function impairment that prevents manipulation of building blocks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: single group
This intervention arm involves a weekly 2-hour building block course that incorporates mental rotation training components.
Participants will engage in structured building block activities designed to enhance spatial reasoning abilities, with specific lesson plans focused on developing mental rotation skills through hands-on construction and manipulation of three-dimensional objects.
|
This study, drawing on the theories proposed by Aguilar Ramirez et al. (2022) and Shepard and Metzler (1971), developed a mental rotation application and a corresponding block-building lesson plan.
Participants then engaged in individual block-building activities, guided by the lesson plan, to train their spatial reasoning skills.
Finally, the developed APP was used for mental rotation training, and its suitability and feasibility were rigorously validated through expert review and a pilot study.
a. Mental Rotation Virtual Reality APP: The APP's content was validated by interdisciplinary experts (including gerontology, activity planning, cognitive training, and information technology) to ensure its appropriateness and feasibility.
The APP incorporates technology-assisted elements, such as real-time feedback and personalized difficulty adjustment for the mental rotation exercises, to enhance training effectiveness and participant motivation.
Furthermore, the built-in "Creative Showcase"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive Function - Montreal Cognitive Assessment (MoCA)
Time Frame: Time Frame: Baseline, pre-intervention
|
Description: The MoCA is a 30-point cognitive screening tool with established reliability in older adults. Higher scores indicate better cognitive function. Unit of Measure: Points on a 30-point scale |
Time Frame: Baseline, pre-intervention
|
|
Spatial Cognition - Mental Rotation Test
Time Frame: Baseline , pre-intervention
|
Description: The Mental Rotation Test assesses spatial cognition. Higher numbers of correct responses indicate better mental rotation ability. Unit of Measure: Number of correct responses |
Baseline , pre-intervention
|
|
Hand Grip Strength - Jamar Hydraulic Hand Dynamometer
Time Frame: Baseline ,pre-intervention
|
Description: Grip strength of each hand is measured using the Jamar dynamometer. Three trials per hand will be averaged. Higher values indicate greater grip strength. Unit of Measure: Kilograms (kg) |
Baseline ,pre-intervention
|
|
Hand Dexterity - Purdue Pegboard Test
Time Frame: Baseline ,pre-intervention
|
Description: The Purdue Pegboard Test assesses fine motor skills and dexterity of the hands and fingers. The score reflects the number of pegs correctly placed in the allotted time. Unit of Measure: Number of pegs placed |
Baseline ,pre-intervention
|
|
Well-Being - WHO-5 Well-Being Index
Time Frame: Baseline , pre-intervention
|
Description: The WHO-5 consists of five items rated on a 25-point scale. Higher scores indicate better well-being and quality of life. Unit of Measure: Points on a 25-point scale |
Baseline , pre-intervention
|
|
System Usability - System Usability Scale (SUS)
Time Frame: Baseline , pre-intervention
|
Description: The SUS assesses usability, learnability, and satisfaction with technology-based systems. Scores range from 0 to 100; higher scores indicate better usability. Unit of Measure: Score on a 0-100 scale |
Baseline , pre-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive Function - Montreal Cognitive Assessment (MoCA)
Time Frame: Immediately After the 4-week Intervention
|
Description: The MoCA is a 30-point cognitive screening tool with established reliability in older adults. Higher scores indicate better cognitive function. Unit of Measure: Points on a 30-point scale |
Immediately After the 4-week Intervention
|
|
Spatial Cognition - Mental Rotation Test
Time Frame: Immediately After the 4-week Intervention
|
Description: The Mental Rotation Test assesses spatial cognition. Higher numbers of correct responses indicate better mental rotation ability. Unit of Measure: Number of correct responses |
Immediately After the 4-week Intervention
|
|
Hand Grip Strength - Jamar Hydraulic Hand Dynamometer
Time Frame: Immediately After the 4-week Intervention
|
Description: Grip strength of each hand is measured using the Jamar dynamometer. Three trials per hand will be averaged. Higher values indicate greater grip strength. Unit of Measure: Kilograms (kg) |
Immediately After the 4-week Intervention
|
|
Hand Dexterity - Purdue Pegboard Test
Time Frame: Immediately After the 4-week Intervention
|
Description: The Purdue Pegboard Test assesses fine motor skills and dexterity of the hands and fingers. The score reflects the number of pegs correctly placed in the allotted time. Unit of Measure: Number of pegs placed |
Immediately After the 4-week Intervention
|
|
Well-Being - WHO-5 Well-Being Index
Time Frame: Immediately After the 4-week Intervention
|
Description: The WHO-5 consists of five items rated on a 25-point scale. Higher scores indicate better well-being and quality of life. Unit of Measure: Points on a 25-point scale |
Immediately After the 4-week Intervention
|
|
System Usability - System Usability Scale (SUS)
Time Frame: Immediately After the 4-week Intervention
|
Description: The SUS assesses usability, learnability, and satisfaction with technology-based systems. Scores range from 0 to 100; higher scores indicate better usability. Unit of Measure: Score on a 0-100 scale |
Immediately After the 4-week Intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FJU-IRB NO:C113099
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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