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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06435078
Other study ID # B-ER-105-238
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 6, 2017
Est. completion date August 21, 2017

Study information

Verified date May 2024
Source National Cheng-Kung University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 21, 2017
Est. primary completion date August 21, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
mPETS(modified-PETS system)
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.

Locations

Country Name City State
Taiwan National Cheng Kung University Tainan

Sponsors (1)

Lead Sponsor Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (53)

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Chen PT, Lin CJ, Jou IM, Chieh HF, Su FC, Kuo LC. One digit interruption: the altered force patterns during functionally cylindrical grasping tasks in patients with trigger digits. PLoS One. 2013 Dec 31;8(12):e83632. doi: 10.1371/journal.pone.0083632. eCollection 2013. — View Citation

Chiu HY, Hsu HY, Kuo LC, Chang JH, Su FC. Functional sensibility assessment. Part I: develop a reliable apparatus to assess momentary pinch force control. J Orthop Res. 2009 Aug;27(8):1116-21. doi: 10.1002/jor.20859. — View Citation

Chiu HY, Hsu HY, Kuo LC, Su FC, Yu HI, Hua SC, Lu CH. How the impact of median neuropathy on sensorimotor control capability of hands for diabetes: an achievable assessment from functional perspectives. PLoS One. 2014 Apr 10;9(4):e94452. doi: 10.1371/journal.pone.0094452. eCollection 2014. — View Citation

Chiu HY, Hsu HY, Su FC, Jou IM, Lin CF, Kuo LC. Setup of a novel biofeedback prototype for sensorimotor control of the hand and preliminary application in patients with peripheral nerve injuries. Phys Ther. 2013 Feb;93(2):168-78. doi: 10.2522/ptj.20120050. Epub 2012 Sep 27. — View Citation

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Hsu HY, Chiu HY, Lin HT, Su FC, Lu CH, Kuo LC. Impacts of elevated glycaemic haemoglobin and disease duration on the sensorimotor control of hands in diabetes patients. Diabetes Metab Res Rev. 2015 May;31(4):385-94. doi: 10.1002/dmrr.2623. Epub 2015 Feb 3. — View Citation

Hsu HY, Kuo LC, Chiu HY, Jou IM, Su FC. Functional sensibility assessment. Part II: Effects of sensory improvement on precise pinch force modulation after transverse carpal tunnel release. J Orthop Res. 2009 Nov;27(11):1534-9. doi: 10.1002/jor.20903. — View Citation

Hsu HY, Kuo LC, Jou IM, Chen SM, Chiu HY, Su FC. Establishment of a proper manual tactile test for hands with sensory deficits. Arch Phys Med Rehabil. 2013 Mar;94(3):451-8. doi: 10.1016/j.apmr.2012.07.024. Epub 2012 Aug 9. — View Citation

Hsu HY, Kuo LC, Kuo YL, Chiu HY, Jou IM, Wu PT, Su FC. Feasibility of a novel functional sensibility test as an assisted examination for determining precision pinch performance in patients with carpal tunnel syndrome. PLoS One. 2013 Aug 20;8(8):e72064. doi: 10.1371/journal.pone.0072064. eCollection 2013. — View Citation

Hsu HY, Kuo YL, Jou IM, Su FC, Chiu HY, Kuo LC. Diagnosis from functional perspectives: usefulness of a manual tactile test for predicting precision pinch performance and disease severity in subjects with carpal tunnel syndrome. Arch Phys Med Rehabil. 2014 Apr;95(4):717-25. doi: 10.1016/j.apmr.2013.11.017. Epub 2013 Dec 16. — View Citation

Hsu HY, Lin CF, Su FC, Kuo HT, Chiu HY, Kuo LC. Clinical application of computerized evaluation and re-education biofeedback prototype for sensorimotor control of the hand in stroke patients. J Neuroeng Rehabil. 2012 May 9;9:26. doi: 10.1186/1743-0003-9-26. — View Citation

Hsu HY, Shieh SJ, Kuan TS, Yang HC, Su FC, Chiu HY, Kuo LC. Manual Tactile Test Predicts Sensorimotor Control Capability of Hands for Patients With Peripheral Nerve Injury. Arch Phys Med Rehabil. 2016 Jun;97(6):983-90. doi: 10.1016/j.apmr.2016.01.008. Epub 2016 Jan 30. — View Citation

Hsu, H.-M., et al., Quantification of handwriting performance: Development of a force acquisition pen for measuring hand-grip and pen tip forces. Measurement, 2013. 46(1): p. 506-513.

Hu X, Loncharich M, Newell KM. Visual information interacts with neuromuscular factors in the coordination of bimanual isometric force. Exp Brain Res. 2011 Mar;209(1):129-38. doi: 10.1007/s00221-010-2528-4. Epub 2010 Dec 28. — View Citation

Hu X, Newell KM. Aging, visual information, and adaptation to task asymmetry in bimanual force coordination. J Appl Physiol (1985). 2011 Dec;111(6):1671-80. doi: 10.1152/japplphysiol.00760.2011. Epub 2011 Sep 29. — View Citation

Jo HJ, Ambike S, Lewis MM, Huang X, Latash ML. Finger force changes in the absence of visual feedback in patients with Parkinson's disease. Clin Neurophysiol. 2016 Jan;127(1):684-692. doi: 10.1016/j.clinph.2015.05.023. Epub 2015 Jun 3. — View Citation

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. — View Citation

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. — View Citation

Kim Y, Shim JK, Hong YK, Lee SH, Yoon BC. Cutaneous sensory feedback plays a critical role in agonist-antagonist co-activation. Exp Brain Res. 2013 Aug;229(2):149-56. doi: 10.1007/s00221-013-3601-6. Epub 2013 Jul 9. — View Citation

Kuo LC, Chen SW, Lin CJ, Lin WJ, Lin SC, Su FC. The force synergy of human digits in static and dynamic cylindrical grasps. PLoS One. 2013;8(3):e60509. doi: 10.1371/journal.pone.0060509. Epub 2013 Mar 27. — View Citation

Kuo LC, Hsu HM, Wu PT, Lin SC, Hsu HY, Jou IM. Impact of distal median neuropathy on handwriting performance for patients with carpal tunnel syndrome in office and administrative support occupations. J Occup Rehabil. 2014 Jun;24(2):332-43. doi: 10.1007/s10926-013-9471-8. — View Citation

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. — View Citation

Lai, K.-Y., et al., Effects of hand span size and right-left hand side on the piano playing performances: Exploration of the potential risk factors with regard to piano-related musculoskeletal disorders. International Journal of Industrial Ergonomics, 2015. 50: p. 97-104.

Langlois F, Vu TT, Chasse K, Dupuis G, Kergoat MJ, Bherer L. Benefits of physical exercise training on cognition and quality of life in frail older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):400-4. doi: 10.1093/geronb/gbs069. Epub 2012 Aug 28. — View Citation

Levanon Y. The advantages and disadvantages of using high technology in hand rehabilitation. J Hand Ther. 2013 Apr-Jun;26(2):179-83. doi: 10.1016/j.jht.2013.02.002. — View Citation

Li K, Marquardt TL, Li ZM. Removal of visual feedback lowers structural variability of inter-digit force coordination during sustained precision pinch. Neurosci Lett. 2013 Jun 17;545:1-5. doi: 10.1016/j.neulet.2013.04.011. Epub 2013 Apr 24. — View Citation

Loucks TM, Ofori E, Sosnoff JJ. Force control under auditory feedback: effector differences and audiomotor memory. Percept Mot Skills. 2012 Jun;114(3):915-35. doi: 10.2466/24.25.27.PMS.114.3.915-935. — View Citation

Manepalli, J., A. Desai, and P. Sharma, Psychosocial-environmental treatments for Alzheimer's disease. Primary Psychiatry, 2009. 16(6): p. 39.

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. — View Citation

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. — View Citation

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Park J, Wu YH, Lewis MM, Huang X, Latash ML. Changes in multifinger interaction and coordination in Parkinson's disease. J Neurophysiol. 2012 Aug 1;108(3):915-24. doi: 10.1152/jn.00043.2012. Epub 2012 May 2. — View Citation

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. — View Citation

Seo NJ, Fischer HW, Bogey RA, Rymer WZ, Kamper DG. Use of visual force feedback to improve digit force direction during pinch grip in persons with stroke: a pilot study. Arch Phys Med Rehabil. 2011 Jan;92(1):24-30. doi: 10.1016/j.apmr.2010.08.016. Epub 2010 Nov 18. — View Citation

Shieh SJ, Hsu HY, Kuo LC, Su FC, Chiu HY. Correlation of digital sensibility and precision of pinch force modulation in patients with nerve repair. J Orthop Res. 2011 Aug;29(8):1210-5. doi: 10.1002/jor.21365. Epub 2011 Mar 4. — View Citation

Shim JK, Karol S, Kim YS, Seo NJ, Kim YH, Kim Y, Yoon BC. Tactile feedback plays a critical role in maximum finger force production. J Biomech. 2012 Feb 2;45(3):415-20. doi: 10.1016/j.jbiomech.2011.12.001. Epub 2012 Jan 4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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Tsai, M.-F., ???????????. ????????????????, 2016: p. 1-94.

Verheij S, Muilwijk D, Pel JJ, van der Cammen TJ, Mattace-Raso FU, van der Steen J. Visuomotor impairment in early-stage Alzheimer's disease: changes in relative timing of eye and hand movements. J Alzheimers Dis. 2012;30(1):131-43. doi: 10.3233/JAD-2012-111883. — View Citation

Wu YH, Pazin N, Zatsiorsky VM, Latash ML. Improving finger coordination in young and elderly persons. Exp Brain Res. 2013 Apr;226(2):273-83. doi: 10.1007/s00221-013-3433-4. Epub 2013 Feb 15. — View Citation

Wu YH, Truglio TS, Zatsiorsky VM, Latash ML. Learning to combine high variability with high precision: lack of transfer to a different task. J Mot Behav. 2015;47(2):153-65. doi: 10.1080/00222895.2014.961892. Epub 2014 Nov 3. — View Citation

Yang CJ, Hsu HY, Lu CH, Chao YL, Chiu HY, Kuo LC. The associations among hand dexterity, functional performance, and quality of life in diabetic patients with neuropathic hand from objective- and patient-perceived measurements. Qual Life Res. 2015 Jan;24(1):213-21. doi: 10.1007/s11136-014-0748-y. Epub 2014 Jul 14. — View Citation

Yen WJ, Kuo YL, Kuo LC, Chen SM, Kuan TS, Hsu HY. Precision pinch performance in patients with sensory deficits of the median nerve at the carpal tunnel. Motor Control. 2014 Jan;18(1):29-43. doi: 10.1123/mc.2013-0004. — View Citation

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. — View Citation

* Note: There are 53 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Force-track testing Subjects will be asked to track the target force and presses task digit to fit the target line until finish. Before and after intervention (4 weeks)
Secondary 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. Before and after intervention (4 weeks)
Secondary 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. Before and after intervention (4 weeks)
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