## Protocol Section
### Identification Module
**NCT ID:** NCT06435078

**Brief Title:** Developments of Novel Virtual Visual and Haptic Stimulation Systems for the Elderly

**Official Title:** Developments of Novel Virtual Visual and Haptic Stimulation Systems for the Elderly

#### Organization Study ID Info
**ID:** B-ER-105-238
#### Organization
**Class:** OTHER
**Full Name:** National Cheng-Kung University Hospital
### Status Module
#### Completion Date
**Date:** 2017-08-21

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-08-21

**Type:** ACTUAL

#### Start Date
**Date:** 2017-03-06

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-28
### 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 sensory input can have positive impacts on finger force control in the elderly. Additionally, according to previous reports, apart from pharmacotherapy, nonpharmacologic interventions, such as psychosocial-environmental treatments, are emerging for the behavior and affective symptoms in AD . 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 AD. Therefore, this study aims to develop novel virtual visual and haptic stimulation systems for the elderly to enhance their finger force control.

### Conditions Module

**Conditions:**

- Healthy Elderly

- Alzheimer Disease

**Keywords:**

- Pressing Evaluation and Training System

- Virtual Reality

- Augmented Reality

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** subjects will be instructed to execute simulated piano playing tasks with Augmented Reality.

**Intervention Names:**

- Device: mPETS(modified-PETS system)

**Label:** AR-mPETS

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** subjects will be instructed to execute simulated piano playing tasks with Virtual Reality.

**Intervention Names:**

- Device: mPETS(modified-PETS system)

**Label:** VR-mPETS

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- AR-mPETS

- VR-mPETS

**Description:** The pressing evaluation and training system (PETS) consists of five force transducers, a pad position-adjustable frame, and biofeedback system. Five force transducers are used to collect the applied normal force from five digits.

**Name:** mPETS(modified-PETS system)

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Subjects will be asked to track the target force and presses task digit to fit the target line until finish.

**Measure:** Force-track testing

**Time Frame:** Before and after intervention (4 weeks)

#### Secondary Outcomes

**Description:** In sequential testing, subjects will be asked to follow the pressing guide. The reaction time of sequential movements will be recorded and calculated.

**Measure:** Sequential testing( reaction time)

**Time Frame:** Before and after intervention (4 weeks)

**Description:** In sequential testing, subjects will be asked to follow the pressing guide. The correct ratio of sequential movements will be recorded and calculated.

**Measure:** Sequential testing( correct ratio )

**Time Frame:** Before and after intervention (4 weeks)

### Eligibility Module

**Eligibility Criteria:** Healthy elderly

Inclusion Criteria:

* Aged ≥ 65
* Healthy adult (no skeletal muscle, neurological disease that will affect training).

Exclusion Criteria:

* Neurological disorders
* Musculoskeletal problems
* History of surgery Patients with Alzheimer's disease

Inclusion Criteria:

* Diagnosed with Alzheimer's disease.
* No skeletal muscle, neurological disease that will affect training.

**Healthy Volunteers:** True

**Maximum Age:** 85 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- 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

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

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**PMID:** 22552184

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003704

- Term: Dementia

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000024801

- Term: Tauopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M3885

- Name: Alzheimer Disease

- Relevance: HIGH

- As Found: Alzheimer's Disease

- ID: M6904

- Name: Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23002

- Name: Tauopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- 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

- ID: T2192

- Name: Familial Alzheimer Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000544

- Term: Alzheimer Disease

### Misc Info Module

- Version Holder: 2024-05-31
