## Protocol Section
### Identification Module
**NCT ID:** NCT06417034

**Brief Title:** Hand Training Device For Cognitive Care

**Official Title:** Hand Training Device For Cognitive Care

#### Organization Study ID Info
**ID:** A-ER-110-485
#### Organization
**Class:** OTHER
**Full Name:** National Cheng-Kung University Hospital
### Status Module
#### Completion Date
**Date:** 2022-04-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-04-11

**Type:** ACTUAL

#### Start Date
**Date:** 2022-03-27

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** National Cheng-Kung University Hospital

#### Responsible Party

**Investigator Affiliation:** National Cheng-Kung University Hospital

**Investigator Full Name:** Fong Chin Su

**Investigator Title:** Chair Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Healthy Elderly

- Mild Cognitive Impairment (MCI)

**Keywords:**

- Functional near infrared spectroscopy

- Parameters of digit force independence

- Pressing Evaluation and Training System

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 80

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: Game Software

**Label:** Music-based game training

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Device: Game Software

**Label:** Non music-based game training

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Music-based game training

- Non music-based game training

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

**Name:** Game Software

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Oxygenated hemoglobin (HbO)

**Time Frame:** 30 minutes

**Description:** 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%.

**Measure:** Montreal Cognitive Assessment (MoCA) test

**Time Frame:** 10 minutes

**Description:** 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.

**Measure:** EN value

**Time Frame:** 5 minutes

#### Secondary Outcomes

**Description:** Maximum voluntary isometric contraction of each digit is measured for training reference.

**Measure:** Maximum voluntary isometric contraction (MVIC)

**Time Frame:** 10 seconds

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 90 Years

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tainan

**Country:** Taiwan

**Facility:** National Cheng Kung University

**Zip:** 701

#### Overall Officials

**Official 1:**

**Affiliation:** Chair Professor

**Name:** Fong-Chin Su, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

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## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003072

- Term: Cognition Disorders

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M29705

- Name: Cognitive Dysfunction

- Relevance: HIGH

- As Found: Mild Cognitive Impairment

- ID: M6301

- Name: Cognition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000060825

- Term: Cognitive Dysfunction

### Misc Info Module

- Version Holder: 2024-05-31
