## Protocol Section
### Identification Module
**NCT ID:** NCT06412887

**Brief Title:** Effects of Adding Force Control to a VR Game on Brain Activation

**Official Title:** Effects of Adding Force Control to a VR Game on Brain Activation

#### Organization Study ID Info
**ID:** 112-181
#### Organization
**Class:** OTHER
**Full Name:** National Cheng-Kung University Hospital
### Status Module
#### Completion Date
**Date:** 2023-08-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-08-11

**Type:** ACTUAL

#### Start Date
**Date:** 2023-07-10

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-25
**Study First Submit QC Date:** 2024-05-08
### 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

### Description Module

**Brief Summary:** One of the major contributor for the lower quality of living in the aged population, is the reduction in hand function. To mitigate this, several virtual-reality based hand rehabilitation/training systems have been developed.

However, most of these systems are solely controlled by hand gestures, and do not incorporate the force between the fingertips. Which is not the case for grabbing things in real life. With that in mind, the researchers assumed that a virtual-reality based hand rehabilitation/training system that incorporates force control into its input can be more beneficial in terms of recovering one's hand function.

To test out this claim, subjects were recruited and tasked to play a game using both input systems (wfc and wofc), while their brain activity while using both input system was simultaneously recorded using functional near infrared spectroscopy and compared

### Conditions Module

**Conditions:**

- Healthy Aging

**Keywords:**

- Virtual Reality

- functional near infrared spectroscopy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** Subjects play the virtual reality game using the wfc input system followed by the wofc input system

##### Masking Info

**Masking:** NONE

**Masking Description:** The subjects were informed regarding which input system was to be used

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 24

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Users play the game using the conventional virtual reality input system with force control

**Intervention Names:**

- Device: Virtual reality headset

**Label:** with force control (wfc)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Users play the game using the conventional virtual reality input system

**Intervention Names:**

- Device: Virtual reality headset

**Label:** without force control (wofc)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- with force control (wfc)

- without force control (wofc)

**Description:** Meta-Quest 2 virtual reality headset was used in this study

**Name:** Virtual reality headset

**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:** 1 hour

**Description:** This unitless metric counts the number of times the subject initiates a grasp while playing the game, a higher amount of grasp initiated signifies worst performance

**Measure:** Game performance1 (Amount of grasp initiated)

**Time Frame:** 1 hour

**Description:** This percentage is calculated by dividing the amount of correct response by the total amount of response. A larger perrcentage represents better performance

**Measure:** Game performance2 (Memory task accuracy)

**Time Frame:** 1 hour

#### Secondary Outcomes

**Description:** The manual dexterity of each participant was measured using the Purdue Pegboard Test at the beginning of the experiment

**Measure:** Manual dexterity

**Time Frame:** 5 minutes

**Description:** The maximum voluntary pinch force of each particapant were measured using the Jamar pinch dynamometer at the beginning of the experiment

**Measure:** Maximum voluntary pinch force

**Time Frame:** 5 minutes

**Description:** The ability to recall information of each particapant was measured using the forward digit span test at the beginning of the experiment

**Measure:** Recall

**Time Frame:** 5 minutes

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* With normal vision or wearing prescription glass that can fit inside the Meta Quest 2 VR headset.
* Able to understand English, Chinese, or Taiwanese language.

Exclusion Criteria:

* Experiencing motion sickness after prolonged usage of VR headsets
* Having chronic diseases or injuries that can prevent them from participating in the experiment such as: hand injuries, missing fingers, blindness, deafness, hearing impairments, etc.

**Healthy Volunteers:** True

**Maximum Age:** 90 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, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

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**PMID:** 26483538

**Citation:** Vergara M, Sancho-Bru JL, Gracia-Ibanez V, Perez-Gonzalez A. An introductory study of common grasps used by adults during performance of activities of daily living. J Hand Ther. 2014 Jul-Sep;27(3):225-33; quiz 234. doi: 10.1016/j.jht.2014.04.002. Epub 2014 Apr 21.

**PMID:** 24878351

**Citation:** Smaby N, Johanson ME, Baker B, Kenney DE, Murray WM, Hentz VR. Identification of key pinch forces required to complete functional tasks. J Rehabil Res Dev. 2004 Mar;41(2):215-24. doi: 10.1682/jrrd.2004.02.0215.

**PMID:** 15558375

**Citation:** Kurillo G, Gregoric M, Goljar N, Bajd T. Grip force tracking system for assessment and rehabilitation of hand function. Technol Health Care. 2005;13(3):137-49.

**PMID:** 15990417

**Citation:** Magni NE, McNair PJ, Rice DA. Impairments in grip and pinch force accuracy and steadiness in people with osteoarthritis of the hand: A case-control comparison. Musculoskelet Sci Pract. 2021 Oct;55:102432. doi: 10.1016/j.msksp.2021.102432. Epub 2021 Jul 22.

**PMID:** 34333399

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**Citation:** Howard, M. C. (2017). A meta-analysis and systematic literature review of virtual reality rehabilitation programs. Computers in Human Behavior, 70, 317-327. https://doi.org/10.1016/j.chb.2017.01.013

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**Citation:** Friedman N, Chan V, Reinkensmeyer AN, Beroukhim A, Zambrano GJ, Bachman M, Reinkensmeyer DJ. Retraining and assessing hand movement after stroke using the MusicGlove: comparison with conventional hand therapy and isometric grip training. J Neuroeng Rehabil. 2014 Apr 30;11:76. doi: 10.1186/1743-0003-11-76.

**PMID:** 24885076

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**PMID:** 28473763

**Citation:** Zheng J, Ma Q, He W, Huang Y, Shi P, Li S, Yu H. Cognitive and motor cortex activation during robot-assisted multi-sensory interactive motor rehabilitation training: An fNIRS based pilot study. Front Hum Neurosci. 2023 Feb 9;17:1089276. doi: 10.3389/fnhum.2023.1089276. eCollection 2023.

**PMID:** 36845877

**Citation:** Xia W, Dai R, Xu X, Huai B, Bai Z, Zhang J, Jin M, Niu W. Cortical mapping of active and passive upper limb training in stroke patients and healthy people: A functional near-infrared spectroscopy study. Brain Res. 2022 Aug 1;1788:147935. doi: 10.1016/j.brainres.2022.147935. Epub 2022 Apr 29.

**PMID:** 35500604

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## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
