NCT06412887

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

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

July 10, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

1 month

First QC Date

April 25, 2024

Last Update Submit

May 8, 2024

Conditions

Keywords

Virtual Realityfunctional near infrared spectroscopy

Outcome Measures

Primary Outcomes (3)

  • Oxygenated hemoglobin (HbO)

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

    1 hour

  • Game performance1 (Amount of grasp initiated)

    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

    1 hour

  • Game performance2 (Memory task accuracy)

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

    1 hour

Secondary Outcomes (3)

  • Manual dexterity

    5 minutes

  • Maximum voluntary pinch force

    5 minutes

  • Recall

    5 minutes

Study Arms (2)

with force control (wfc)

ACTIVE COMPARATOR

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

Device: Virtual reality headset

without force control (wofc)

EXPERIMENTAL

Users play the game using the conventional virtual reality input system

Device: Virtual reality headset

Interventions

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

with force control (wfc)without force control (wofc)

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University

Tainan, 701, Taiwan

Location

Related Publications (14)

  • Kivell TL. Evidence in hand: recent discoveries and the early evolution of human manual manipulation. Philos Trans R Soc Lond B Biol Sci. 2015 Nov 19;370(1682):20150105. doi: 10.1098/rstb.2015.0105.

    PMID: 26483538BACKGROUND
  • 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: 24878351BACKGROUND
  • 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: 15558375BACKGROUND
  • 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: 15990417BACKGROUND
  • 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: 34333399BACKGROUND
  • Strote C, Golz C, Stroehlein JK, Haase FK, Koester D, Reinsberger C, Vieluf S. Effects of force level and task difficulty on force control performance in elderly people. Exp Brain Res. 2020 Oct;238(10):2179-2188. doi: 10.1007/s00221-020-05864-1. Epub 2020 Jul 13.

    PMID: 32661649BACKGROUND
  • 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

    BACKGROUND
  • Pereira, M. F., Prahm, C., Kolbenschlag, J., Oliveira, E., & Rodrigues, N. F. (2020). A Virtual Reality Serious Game for Hand Rehabilitation Therapy. 2020 IEEE 8th International Conference on Serious Games and Applications for Health (SeGAH), 1-7. https://doi.org/10.1109/SeGAH49190.2020.9201789

    BACKGROUND
  • Vanbellingen T, Filius SJ, Nyffeler T, van Wegen EEH. Usability of Videogame-Based Dexterity Training in the Early Rehabilitation Phase of Stroke Patients: A Pilot Study. Front Neurol. 2017 Dec 8;8:654. doi: 10.3389/fneur.2017.00654. eCollection 2017.

    PMID: 29276499BACKGROUND
  • 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: 24885076BACKGROUND
  • Bae SJ, Jang SH, Seo JP, Chang PH. The Optimal Speed for Cortical Activation of Passive Wrist Movements Performed by a Rehabilitation Robot: A Functional NIRS Study. Front Hum Neurosci. 2017 Apr 20;11:194. doi: 10.3389/fnhum.2017.00194. eCollection 2017.

    PMID: 28473763BACKGROUND
  • 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: 36845877BACKGROUND
  • 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: 35500604BACKGROUND
  • Hummel, J., Dodiya, J., Wolff, R., Gerndt, A., & Kuhlen, T. (2013). An evaluation of two simple methods for representing heaviness in immersive virtual environments. 2013 IEEE Symposium on 3D User Interfaces (3DUI), 87-94. https://doi.org/10.1109/3DUI.2013.6550202

    BACKGROUND

Study Officials

  • Fong-Chin Su, PhD

    Chair Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The subjects were informed regarding which input system was to be used
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Subjects play the virtual reality game using the wfc input system followed by the wofc input system
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Professor

Study Record Dates

First Submitted

April 25, 2024

First Posted

May 14, 2024

Study Start

July 10, 2023

Primary Completion

August 11, 2023

Study Completion

August 11, 2023

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations