NCT06417034

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2022

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

15 days

First QC Date

May 12, 2024

Last Update Submit

May 23, 2024

Conditions

Keywords

Functional near infrared spectroscopyParameters of digit force independencePressing Evaluation and Training System

Outcome Measures

Primary Outcomes (3)

  • Oxygenated hemoglobin (HbO)

    The Oxygenated hemoglobin (HbO) was measured while the participants play the game under both conditions

    30 minutes

  • Montreal Cognitive Assessment (MoCA) test

    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

    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 Outcomes (1)

  • Maximum voluntary isometric contraction (MVIC)

    10 seconds

Study Arms (2)

Music-based game training

EXPERIMENTAL

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

Non music-based game training

ACTIVE COMPARATOR

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

Interventions

The software is interfaced with a modified version of Frets on Fire (FOF)-an open source computer game similar to Guitar Hero.

Music-based game trainingNon music-based game training

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University

Tainan, 701, Taiwan

Location

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MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Fong-Chin Su, PhD

    Chair Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Professor

Study Record Dates

First Submitted

May 12, 2024

First Posted

May 16, 2024

Study Start

March 27, 2022

Primary Completion

April 11, 2022

Study Completion

April 11, 2022

Last Updated

May 28, 2024

Record last verified: 2024-05

Locations