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AzTrials

Healthy ElderlyNCT06435078

Developments of Novel Virtual Visual and Haptic Stimulation Systems for the Elderly

A study testing mPETS(modified-PETS system) in people with Healthy Elderly and Alzheimer Disease, 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

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… Read more about this study

Who is it for?
Ages 20 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Elderly, Alzheimer Disease
What is being tested?
mPETS(modified-PETS system)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTaiwan
Study dates
6 Mar 2017to 21 Aug 2017
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 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged ≥ 65
  • Healthy adult (no skeletal muscle, neurological disease that will affect training).
  • Diagnosed with Alzheimer's disease.
  • No skeletal muscle, neurological disease that will affect training.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Cheng Kung University

    Tainan, 701

Other trials in Taiwan

About this study

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.

Being tested
mPETS(modified-PETS system)
Keywords
Pressing Evaluation and Training System, Virtual Reality, Augmented Reality
Medical subject headings
Alzheimer Disease

What participants receive

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

  • mPETS(modified-PETS system)Device

    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.

Study groups in NCT06435078
Study groupRoleWhat they receive
AR-mPETSExperimentalsubjects will be instructed to execute simulated piano playing tasks with Augmented Reality.
Receives: Device: mPETS(modified-PETS system)
VR-mPETSActive comparatorsubjects will be instructed to execute simulated piano playing tasks with Virtual Reality.
Receives: Device: mPETS(modified-PETS system)

What is being measured

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

  1. Force-track testing

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

    Measured: Before and after intervention (4 weeks)

Secondary outcomes (2)

  1. Sequential testing( reaction time)

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

    Measured: Before and after intervention (4 weeks)

  2. Sequential testing( correct ratio )

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

    Measured: Before and after intervention (4 weeks)

Timeline

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

  1. First posted30 May 2024
  2. Study start6 Mar 2017
  3. Primary completion21 Aug 2017
  4. Study completion21 Aug 2017

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
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06435078
Sponsor's protocol ID
B-ER-105-238
Status last verified
May 2024
First submitted
22 May 2024
Last updated
31 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Organization, W.H., Global health and aging. Acedido março, 2011. 5: p. 2015.

  • Grabiner MD, Enoka RM. Changes in movement capabilities with aging. Exerc Sport Sci Rev. 1995;23:65-104. No abstract available.

    PubMed 7556361

  • Ranganathan VK, Siemionow V, Sahgal V, Liu JZ, Yue GH. Skilled finger movement exercise improves hand function. J Gerontol A Biol Sci Med Sci. 2001 Aug;56(8):M518-22. doi: 10.1093/gerona/56.8.m518.

    PubMed 11487606

  • Olafsdottir HB, Zatsiorsky VM, Latash ML. The effects of strength training on finger strength and hand dexterity in healthy elderly individuals. J Appl Physiol (1985). 2008 Oct;105(4):1166-78. doi: 10.1152/japplphysiol.00054.2008. Epub 2008 Aug 7.

    PubMed 18687981

  • Keogh JW, Morrison S, Barrett R. Strength training improves the tri-digit finger-pinch force control of older adults. Arch Phys Med Rehabil. 2007 Aug;88(8):1055-63. doi: 10.1016/j.apmr.2007.05.014.

    PubMed 17678670

  • Kwok TC, Lam KC, Wong PS, Chau WW, Yuen KS, Ting KT, Chung EW, Li JC, Ho FK. Effectiveness of coordination exercise in improving cognitive function in older adults: a prospective study. Clin Interv Aging. 2011;6:261-7. doi: 10.2147/CIA.S19883. Epub 2011 Sep 29.

    PubMed 22087065

  • Zhang W, Scholz JP, Zatsiorsky VM, Latash ML. What do synergies do? Effects of secondary constraints on multidigit synergies in accurate force-production tasks. J Neurophysiol. 2008 Feb;99(2):500-13. doi: 10.1152/jn.01029.2007. Epub 2007 Nov 28.

    PubMed 18046000

  • Kim SW, Shim JK, Zatsiorsky VM, Latash ML. Finger inter-dependence: linking the kinetic and kinematic variables. Hum Mov Sci. 2008 Jun;27(3):408-22. doi: 10.1016/j.humov.2007.08.005. Epub 2008 Feb 5.

    PubMed 18255182

  • Shim JK, Lay BS, Zatsiorsky VM, Latash ML. Age-related changes in finger coordination in static prehension tasks. J Appl Physiol (1985). 2004 Jul;97(1):213-24. doi: 10.1152/japplphysiol.00045.2004. Epub 2004 Mar 5.

    PubMed 15003998

  • Parikh PJ, Cole KJ. Handling objects in old age: forces and moments acting on the object. J Appl Physiol (1985). 2012 Apr;112(7):1095-104. doi: 10.1152/japplphysiol.01385.2011. Epub 2012 Jan 12.

    PubMed 22241054

  • Shinohara M, Scholz JP, Zatsiorsky VM, Latash ML. Finger interaction during accurate multi-finger force production tasks in young and elderly persons. Exp Brain Res. 2004 Jun;156(3):282-92. doi: 10.1007/s00221-003-1786-9. Epub 2004 Feb 19.

    PubMed 14985892

  • Shinohara M, Li S, Kang N, Zatsiorsky VM, Latash ML. Effects of age and gender on finger coordination in MVC and submaximal force-matching tasks. J Appl Physiol (1985). 2003 Jan;94(1):259-70. doi: 10.1152/japplphysiol.00643.2002. Epub 2002 Sep 13.

    PubMed 12391031

  • Olafsdottir H, Zhang W, Zatsiorsky VM, Latash ML. Age-related changes in multifinger synergies in accurate moment of force production tasks. J Appl Physiol (1985). 2007 Apr;102(4):1490-501. doi: 10.1152/japplphysiol.00966.2006. Epub 2007 Jan 4.

    PubMed 17204576

  • Cobos, F.J.M. and M.d.M.M. Rodríguez, A Review of psychological intervention in Alzheimer s disease. International Journal of Psychology and Psychological Therapy, 2012. 12(3): p. 373-388.

  • Franssen EH, Souren LE, Torossian CL, Reisberg B. Equilibrium and limb coordination in mild cognitive impairment and mild Alzheimer's disease. J Am Geriatr Soc. 1999 Apr;47(4):463-9. doi: 10.1111/j.1532-5415.1999.tb07240.x.

    PubMed 10203123

Questions about this trial

What is this clinical trial studying?

A study testing mPETS(modified-PETS system) in people with Healthy Elderly and Alzheimer Disease, 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 4 inclusion and 3 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 31 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?

Force-track testing (time frame: Before and after intervention (4 weeks)). 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 NCT06435078, which also lists 53 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 31 May 2024.

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