Hand Training Device For Cognitive Care

May 23, 2024 updated by: Fong Chin Su, National Cheng-Kung University Hospital
Previous studies indicated that auditory stimulation as an external cue might have positive impacts on sensorimotor synchronization. Additionally, according to previous reports apart from traditional interventions, digitized game-based device, such as FTOMBVG, are beneficial for the brain activation in elderly. Moreover, enhanced finger force control and coordination lead to better hand dexterity and is believed to eventually improve life independence in the healthy elderly and the elderly with cognitive decline. Therefore, this study aims to develop an advanced systems based on the previous one, that can provide hand function rehabilitation, cognitive training, and emotional comfort for the elderly or people suffer from cognitive deficiency. They can enhance their finger force control or visual to motor synchronization by music embedded during the gaming process.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Taiwan
      • Tainan, Taiwan, 701
        • National Cheng Kung University

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:

  • Ability to communicate in Mandarin Chinese or Taiwanese
  • MCI, according to clinical neurological assessment, Montreal Cognitive Assessment (MoCA):≦25&≧19
  • Ability to perform ADL independently, no hand function disability
  • Voluntarily participation and ability to sign the informed consent form

Exclusion Criteria:

  • Alzheimers disease diagnosed by physicians or meeting the diagnostic criteria for dementia
  • Physician's diagnosis of stroke
  • Any mental illness or behavior problems and inability to cooperate with the trainer
  • Visual impairment or hand diseases resulting in an inability to perform finger press
  • received other cognitive or physical training in the past year
  • any sight, hearing, or communication impairment

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music-based game training
Subjects will be asked to press their finger while a series of archery target continuously drop down and pass by the bottom line follow the beats of music melody on Tipr.
Device: Game Software
The software is interfaced with a modified version of Frets on Fire (FOF)-an open source computer game similar to Guitar Hero.
Active Comparator: Non music-based game training
The background music will be disabled. Subjects need to press equally amount of force in certain tolerance that been set by only the visual cue on Tipr.
Device: Game Software
The software is interfaced with a modified version of Frets on Fire (FOF)-an open source computer game similar to Guitar Hero.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenated hemoglobin (HbO)
Time Frame: 30 minutes
The Oxygenated hemoglobin (HbO) was measured while the participants play the game under both conditions
30 minutes
Montreal Cognitive Assessment (MoCA) test
Time Frame: 10 minutes
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: Short term memory, Visuospatial abilities, Executive functions, Attention, concentration and working memory, Language, Orientation to time and place. The sensitivity of MoCA for detecting MCI is 90%.
10 minutes
EN value
Time Frame: 5 minutes
The force independence is collected from the data during force control game in each evaluation session. The parameter of force independence is an index of five digits overall enslaving presented as EN.
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum voluntary isometric contraction (MVIC)
Time Frame: 10 seconds
Maximum voluntary isometric contraction of each digit is measured for training reference.
10 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Investigators

  • Principal Investigator: Fong-Chin Su, PhD, Chair Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 27, 2022

Primary Completion (Actual)

April 11, 2022

Study Completion (Actual)

April 11, 2022

Study Registration Dates

First Submitted

May 12, 2024

First Submitted That Met QC Criteria

May 12, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-ER-110-485

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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