AzTrials
AzTrials

Healthy AgingNCT06412887

Effects of Adding Force Control to a VR Game on Brain Activation

A study testing Virtual reality headset in people with Healthy Aging, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Aging
What is being tested?
Virtual reality headset
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteTaiwan
Study dates
10 Jul 2023to 11 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Cheng Kung University

    Tainan, 701

Other trials in Taiwan

About this study

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
Healthy Aging
Being tested
Virtual reality headset
Keywords
Virtual Reality, functional near infrared spectroscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual reality headsetDevice

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

Study groups in NCT06412887
Study groupRoleWhat they receive
with force control (wfc)Active comparatorUsers play the game using the conventional virtual reality input system with force control
Receives: Device: Virtual reality headset
without force control (wofc)ExperimentalUsers play the game using the conventional virtual reality input system
Receives: Device: Virtual reality headset

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxygenated hemoglobin (HbO)

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

    Measured: 1 hour

  2. 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

    Measured: 1 hour

  3. 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

    Measured: 1 hour

Secondary outcomes (3)

  1. Manual dexterity

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

    Measured: 5 minutes

  2. Maximum voluntary pinch force

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

    Measured: 5 minutes

  3. Recall

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

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2024
  2. Study start10 Jul 2023
  3. Primary completion11 Aug 2023
  4. Study completion11 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
Subjects play the virtual reality game using the wfc input system followed by the wofc input system
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06412887
Sponsor's protocol ID
112-181
Status last verified
May 2024
First submitted
25 Apr 2024
Last updated
14 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26483538

  • 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.

    PubMed 24878351

  • 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.

    PubMed 15558375

  • 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.

    PubMed 15990417

  • 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.

    PubMed 34333399

  • 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.

    PubMed 32661649

  • 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

  • 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

  • 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.

    PubMed 29276499

  • 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.

    PubMed 24885076

  • 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.

    PubMed 28473763

  • 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.

    PubMed 36845877

  • 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.

    PubMed 35500604

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality headset in people with Healthy Aging, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxygenated hemoglobin (HbO) (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06412887, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.

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