Clinical trial NCT06417034: Hand Training Device For Cognitive Care
Official title: Hand Training Device For Cognitive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Elderly
Mild Cognitive Impairment (MCI)
Keywords: Functional near infrared spectroscopy
Parameters of digit force independence
Pressing Evaluation and Training System
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Previous studies indicated that auditory stimulation as an external cue might have positive impacts on sensorimotor synchronization. Additionally, according to previous reports apart from traditional interventions, digitized game-based device, such as FTOMBVG, are beneficial for the brain activation in elderly. 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 cognitive decline. Therefore, this study aims to develop an advanced systems based on the previous one, that can provide hand function rehabilitation, cognitive training, and emotional comfort for the elderly or people suffer from cognitive deficiency. They can enhance their finger force control or visual to motor synchronization by music embedded during the gaming process.


Eligibility criteria: Inclusion Criteria:

* Ability to communicate in Mandarin Chinese or Taiwanese
* MCI, according to clinical neurological assessment, Montreal Cognitive Assessment (MoCA):≦25\&≧19
* Ability to perform ADL independently, no hand function disability
* Voluntarily participation and ability to sign the informed consent form

Exclusion Criteria:

* Alzheimers disease diagnosed by physicians or meeting the diagnostic criteria for dementia
* Physician's diagnosis of stroke
* Any mental illness or behavior problems and inability to cooperate with the trainer
* Visual impairment or hand diseases resulting in an inability to perform finger press
* received other cognitive or physical training in the past year
* any sight, hearing, or communication impairment

Primary outcomes:
measure: Oxygenated hemoglobin (HbO)
timeFrame: 30 minutes
measure: Montreal Cognitive Assessment (MoCA) test
timeFrame: 10 minutes
measure: EN value
timeFrame: 5 minutes
Secondary outcomes:
measure: Maximum voluntary isometric contraction (MVIC)
timeFrame: 10 seconds
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: Chair Professor
name: Fong-Chin Su, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Organization, W.H., Global health and aging. Geneva: World Health Organization, 2011.
citation: Olshansky SJ, Ault AB. The fourth stage of the epidemiologic transition: the age of delayed degenerative diseases. Milbank Q. 1986;64(3):355-91.
citation: Sun Y, Lee HJ, Yang SC, Chen TF, Lin KN, Lin CC, Wang PN, Tang LY, Chiu MJ. A nationwide survey of mild cognitive impairment and dementia, including very mild dementia, in Taiwan. PLoS One. 2014 Jun 18;9(6):e100303. doi: 10.1371/journal.pone.0100303. eCollection 2014.
citation: Wimo A, Guerchet M, Ali GC, Wu YT, Prina AM, Winblad B, Jonsson L, Liu Z, Prince M. The worldwide costs of dementia 2015 and comparisons with 2010. Alzheimers Dement. 2017 Jan;13(1):1-7. doi: 10.1016/j.jalz.2016.07.150. Epub 2016 Aug 29.
citation: Langa KM, Levine DA. The diagnosis and management of mild cognitive impairment: a clinical review. JAMA. 2014 Dec 17;312(23):2551-61. doi: 10.1001/jama.2014.13806.
citation: Maioli F, Coveri M, Pagni P, Chiandetti C, Marchetti C, Ciarrocchi R, Ruggero C, Nativio V, Onesti A, D'Anastasio C, Pedone V. Conversion of mild cognitive impairment to dementia in elderly subjects: a preliminary study in a memory and cognitive disorder unit. Arch Gerontol Geriatr. 2007;44 Suppl 1:233-41. doi: 10.1016/j.archger.2007.01.032.
citation: Abou Kassm S, Naja W, Hoertel N, Limosin F. [Pharmacological management of delusions associated with dementia]. Geriatr Psychol Neuropsychiatr Vieil. 2019 Sep 1;17(3):317-326. doi: 10.1684/pnv.2019.0813. French.
citation: Folch J, Busquets O, Ettcheto M, Sanchez-Lopez E, Castro-Torres RD, Verdaguer E, Garcia ML, Olloquequi J, Casadesus G, Beas-Zarate C, Pelegri C, Vilaplana J, Auladell C, Camins A. Memantine for the Treatment of Dementia: A Review on its Current and Future Applications. J Alzheimers Dis. 2018;62(3):1223-1240. doi: 10.3233/JAD-170672.
citation: Groot C, Hooghiemstra AM, Raijmakers PG, van Berckel BN, Scheltens P, Scherder EJ, van der Flier WM, Ossenkoppele R. The effect of physical activity on cognitive function in patients with dementia: A meta-analysis of randomized control trials. Ageing Res Rev. 2016 Jan;25:13-23. doi: 10.1016/j.arr.2015.11.005. Epub 2015 Nov 28.
citation: Brasure M, Desai P, Davila H, Nelson VA, Calvert C, Jutkowitz E, Butler M, Fink HA, Ratner E, Hemmy LS, McCarten JR, Barclay TR, Kane RL. Physical Activity Interventions in Preventing Cognitive Decline and Alzheimer-Type Dementia: A Systematic Review. Ann Intern Med. 2018 Jan 2;168(1):30-38. doi: 10.7326/M17-1528. Epub 2017 Dec 19.
citation: Baird A, Samson S. Music and dementia. Prog Brain Res. 2015;217:207-35. doi: 10.1016/bs.pbr.2014.11.028. Epub 2015 Jan 31.
citation: Woods B, O'Philbin L, Farrell EM, Spector AE, Orrell M. Reminiscence therapy for dementia. Cochrane Database Syst Rev. 2018 Mar 1;3(3):CD001120. doi: 10.1002/14651858.CD001120.pub3.
citation: Spector A, Orrell M, Woods B. Cognitive Stimulation Therapy (CST): effects on different areas of cognitive function for people with dementia. Int J Geriatr Psychiatry. 2010 Dec;25(12):1253-8. doi: 10.1002/gps.2464.
citation: Spector A, Orrell M, Davies S, Woods B. Reality orientation for dementia. Cochrane Database Syst Rev. 2000;(4):CD001119. doi: 10.1002/14651858.CD001119.
citation: Diaz-Perez E, Florez-Lozano JA. [Virtual reality and dementia]. Rev Neurol. 2018 May 16;66(10):344-352. Spanish.
citation: Reijnders J, van Heugten C, van Boxtel M. Cognitive interventions in healthy older adults and people with mild cognitive impairment: a systematic review. Ageing Res Rev. 2013 Jan;12(1):263-75. doi: 10.1016/j.arr.2012.07.003. Epub 2012 Jul 25.
citation: Lam NW, Goh HT, Kamaruzzaman SB, Chin AV, Poi PJ, Tan MP. Normative data for hand grip strength and key pinch strength, stratified by age and gender for a multiethnic Asian population. Singapore Med J. 2016 Oct;57(10):578-584. doi: 10.11622/smedj.2015164. Epub 2015 Nov 13.
citation: Y. Fu, D.-H. Wang, Cognitive aging and the brain: HAROLD model debate, Adv. Psychol. Sci. 17 86- 91 (2009).
citation: Scherder E, Dekker W, Eggermont L. Higher-level hand motor function in aging and (preclinical) dementia: its relationship with (instrumental) activities of daily life--a mini-review. Gerontology. 2008;54(6):333-41. doi: 10.1159/000168203. Epub 2008 Nov 11.
citation: Volkers KM, Scherder EJ. Physical performance is associated with working memory in older people with mild to severe cognitive impairment. Biomed Res Int. 2014;2014:762986. doi: 10.1155/2014/762986. Epub 2014 Mar 16.
citation: Fauth EB, Schaefer SY, Zarit SH, Ernsth-Bravell M, Johansson B. Associations Between Fine Motor Performance in Activities of Daily Living and Cognitive Ability in a Nondemented Sample of Older Adults: Implications for Geriatric Physical Rehabilitation. J Aging Health. 2017 Oct;29(7):1144-1159. doi: 10.1177/0898264316654674. Epub 2016 Jun 22.
citation: Babiloni C, Frisoni GB, Pievani M, Vecchio F, Infarinato F, Geroldi C, Salinari S, Ferri R, Fracassi C, Eusebi F, Rossini PM. White matter vascular lesions are related to parietal-to-frontal coupling of EEG rhythms in mild cognitive impairment. Hum Brain Mapp. 2008 Dec;29(12):1355-67. doi: 10.1002/hbm.20467.
citation: Imran MB, Kawashima R, Awata S, Sato K, Kinomura S, Ono S, Sato M, Fukuda H. Tc-99m HMPAO SPECT in the evaluation of Alzheimer's disease: correlation between neuropsychiatric evaluation and CBF images. J Neurol Neurosurg Psychiatry. 1999 Feb;66(2):228-32. doi: 10.1136/jnnp.66.2.228.
citation: Ehrsson HH, Fagergren E, Forssberg H. Differential fronto-parietal activation depending on force used in a precision grip task: an fMRI study. J Neurophysiol. 2001 Jun;85(6):2613-23. doi: 10.1152/jn.2001.85.6.2613.
citation: Umetsu A, Okuda J, Fujii T, Tsukiura T, Nagasaka T, Yanagawa I, Sugiura M, Inoue K, Kawashima R, Suzuki K, Tabuchi M, Murata T, Mugikura S, Higano S, Takahashi S, Fukuda H, Yamadori A. Brain activation during the fist-edge-palm test: a functional MRI study. Neuroimage. 2002 Sep;17(1):385-92. doi: 10.1006/nimg.2002.1218.
citation: Sawamoto N, Honda M, Hanakawa T, Aso T, Inoue M, Toyoda H, Ishizu K, Fukuyama H, Shibasaki H. Cognitive slowing in Parkinson disease is accompanied by hypofunctioning of the striatum. Neurology. 2007 Mar 27;68(13):1062-8. doi: 10.1212/01.wnl.0000257821.28992.db.
citation: Zhang N, Yuan X, Li Q, Wang Z, Gu X, Zang J, Ge R, Liu H, Fan Z, Bu L. The effects of age on brain cortical activation and functional connectivity during video game-based finger-to-thumb opposition movement: A functional near-infrared spectroscopy study. Neurosci Lett. 2021 Feb 16;746:135668. doi: 10.1016/j.neulet.2021.135668. Epub 2021 Jan 23.
citation: Chen LL, Li H, Chen XH, Jin S, Chen QH, Chen MR, Li N. Effects of Hand Exercise on Eating Action in Patients With Alzheimer's Disease. Am J Alzheimers Dis Other Demen. 2019 Feb;34(1):57-62. doi: 10.1177/1533317518803722. Epub 2018 Oct 9.
citation: de Boer C, Echlin HV, Rogojin A, Baltaretu BR, Sergio LE. Thinking-While-Moving Exercises May Improve Cognition in Elderly with Mild Cognitive Deficits: A Proof-of-Principle Study. Dement Geriatr Cogn Dis Extra. 2018 Jul 11;8(2):248-258. doi: 10.1159/000490173. eCollection 2018 May-Aug.
citation: Gates NJ, Sachdev PS, Fiatarone Singh MA, Valenzuela M. Cognitive and memory training in adults at risk of dementia: a systematic review. BMC Geriatr. 2011 Sep 25;11:55. doi: 10.1186/1471-2318-11-55.
citation: Sarkamo T, Ripolles P, Vepsalainen H, Autti T, Silvennoinen HM, Salli E, Laitinen S, Forsblom A, Soinila S, Rodriguez-Fornells A. Structural changes induced by daily music listening in the recovering brain after middle cerebral artery stroke: a voxel-based morphometry study. Front Hum Neurosci. 2014 Apr 17;8:245. doi: 10.3389/fnhum.2014.00245. eCollection 2014.
citation: Bruscia KE. Defining Music Therapy. 3rd ed. University Park, IL: Barcelona Publishers; (2014).
citation: Wheeler BL. Music Therapy Handbook. New York: Guilford Publications; (2015).
citation: Robb SL, Hanson-Abromeit D, May L, Hernandez-Ruiz E, Allison M, Beloat A, Daugherty S, Kurtz R, Ott A, Oyedele OO, Polasik S, Rager A, Rifkin J, Wolf E. Reporting quality of music intervention research in healthcare: A systematic review. Complement Ther Med. 2018 Jun;38:24-41. doi: 10.1016/j.ctim.2018.02.008. Epub 2018 Mar 7.
citation: Lim HB, Karageorghis CI, Romer LM, Bishop DT. Psychophysiological effects of synchronous versus asynchronous music during cycling. Med Sci Sports Exerc. 2014 Feb;46(2):407-13. doi: 10.1249/MSS.0b013e3182a6378c.
citation: Ramji R, Aasa U, Paulin J, Madison G. Musical information increases physical performance for synchronous but not asynchronous running. Psychol Music.;44(5):984-95 (2016).
citation: Buhmann J, Moens B, Van Dyck E, Dotov D, Leman M. Optimizing beat synchronized running to music. PLoS One. 2018 Dec 6;13(12):e0208702. doi: 10.1371/journal.pone.0208702. eCollection 2018.
citation: Jin X, Wang B, Lv Y, Lu Y, Chen J, Zhou C. Does dance training influence beat sensorimotor synchronization? Differences in finger-tapping sensorimotor synchronization between competitive ballroom dancers and nondancers. Exp Brain Res. 2019 Mar;237(3):743-753. doi: 10.1007/s00221-018-5410-4. Epub 2019 Jan 2.
citation: Miura A, Kudo K, Ohtsuki T, Kanehisa H, Nakazawa K. Relationship between muscle cocontraction and proficiency in whole-body sensorimotor synchronization: a comparison study of street dancers and nondancers. Motor Control. 2013 Jan;17(1):18-33. doi: 10.1123/mcj.17.1.18. Epub 2012 Sep 7.
citation: Friedman N, Chan V, Zondervan D, Bachman M, Reinkensmeyer DJ. MusicGlove: motivating and quantifying hand movement rehabilitation by using functional grips to play music. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:2359-63. doi: 10.1109/IEMBS.2011.6090659.
citation: Han E, Park J, Kim H, Jo G, Do HK, Lee BI. Cognitive Intervention with Musical Stimuli Using Digital Devices on Mild Cognitive Impairment: A Pilot Study. Healthcare (Basel). 2020 Feb 25;8(1):45. doi: 10.3390/healthcare8010045.
citation: Semjen A, Ivry RB. The coupled oscillator model of between-hand coordination in alternate-hand tapping: a reappraisal. J Exp Psychol Hum Percept Perform. 2001 Apr;27(2):251-65. doi: 10.1037//0096-1523.27.2.251.
citation: Patel AD, Iversen JR, Chen Y, Repp BH. The influence of metricality and modality on synchronization with a beat. Exp Brain Res. 2005 May;163(2):226-38. doi: 10.1007/s00221-004-2159-8. Epub 2005 Jan 15.
citation: Tierney A, Kraus N. The ability to move to a beat is linked to the consistency of neural responses to sound. J Neurosci. 2013 Sep 18;33(38):14981-8. doi: 10.1523/JNEUROSCI.0612-13.2013.
citation: Blais M, Albaret JM, Tallet J. Is there a link between sensorimotor coordination and inter-manual coordination? Differential effects of auditory and/or visual rhythmic stimulations. Exp Brain Res. 2015 Nov;233(11):3261-9. doi: 10.1007/s00221-015-4394-6. Epub 2015 Aug 4.
citation: Sarkamo T, Pihko E, Laitinen S, Forsblom A, Soinila S, Mikkonen M, Autti T, Silvennoinen HM, Erkkila J, Laine M, Peretz I, Hietanen M, Tervaniemi M. Music and speech listening enhance the recovery of early sensory processing after stroke. J Cogn Neurosci. 2010 Dec;22(12):2716-27. doi: 10.1162/jocn.2009.21376.
citation: Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
citation: Sarkamo T, Laitinen S, Numminen A, Kurki M, Johnson JK, Rantanen P. Pattern of Emotional Benefits Induced by Regular Singing and Music Listening in Dementia. J Am Geriatr Soc. 2016 Feb;64(2):439-40. doi: 10.1111/jgs.13963. No abstract available.
citation: Sarkamo T, Laitinen S, Numminen A, Kurki M, Johnson JK, Rantanen P. Clinical and Demographic Factors Associated with the Cognitive and Emotional Efficacy of Regular Musical Activities in Dementia. J Alzheimers Dis. 2016;49(3):767-81. doi: 10.3233/JAD-150453.
citation: Sarkamo T, Tervaniemi M, Laitinen S, Numminen A, Kurki M, Johnson JK, Rantanen P. Cognitive, emotional, and social benefits of regular musical activities in early dementia: randomized controlled study. Gerontologist. 2014 Aug;54(4):634-50. doi: 10.1093/geront/gnt100. Epub 2013 Sep 5.
citation: Pohl P, Dizdar N, Hallert E. The Ronnie Gardiner Rhythm and Music Method - a feasibility study in Parkinson's disease. Disabil Rehabil. 2013;35(26):2197-204. doi: 10.3109/09638288.2013.774060. Epub 2013 Mar 12.
citation: Altenmuller E, Marco-Pallares J, Munte TF, Schneider S. Neural reorganization underlies improvement in stroke-induced motor dysfunction by music-supported therapy. Ann N Y Acad Sci. 2009 Jul;1169:395-405. doi: 10.1111/j.1749-6632.2009.04580.x.
citation: Sihvonen AJ, Sarkamo T, Leo V, Tervaniemi M, Altenmuller E, Soinila S. Music-based interventions in neurological rehabilitation. Lancet Neurol. 2017 Aug;16(8):648-660. doi: 10.1016/S1474-4422(17)30168-0. Epub 2017 Jun 26.
citation: Jacobsen JH, Stelzer J, Fritz TH, Chetelat G, La Joie R, Turner R. Why musical memory can be preserved in advanced Alzheimer's disease. Brain. 2015 Aug;138(Pt 8):2438-50. doi: 10.1093/brain/awv135. Epub 2015 Jun 3.
citation: Cotelli M, Manenti R, Brambilla M, Gobbi E, Ferrari C, Binetti G, Cappa SF. Cognitive telerehabilitation in mild cognitive impairment, Alzheimer's disease and frontotemporal dementia: A systematic review. J Telemed Telecare. 2019 Feb;25(2):67-79. doi: 10.1177/1357633X17740390. Epub 2017 Nov 8.
citation: Burton RL, O'Connell ME. Telehealth Rehabilitation for Cognitive Impairment: Randomized Controlled Feasibility Trial. JMIR Res Protoc. 2018 Feb 8;7(2):e43. doi: 10.2196/resprot.9420.
citation: Ty, J. et al. in Human Aspects of IT for the Aged Population. Social Media, Games and Assistive Environments. (eds Jia Zhou & Gavriel Salvendy) 575-587 (Springer International Publishing).
citation: Suzuki T, Shimada H, Makizako H, Doi T, Yoshida D, Tsutsumimoto K, Anan Y, Uemura K, Lee S, Park H. Effects of multicomponent exercise on cognitive function in older adults with amnestic mild cognitive impairment: a randomized controlled trial. BMC Neurol. 2012 Oct 31;12:128. doi: 10.1186/1471-2377-12-128.
citation: Park S, Bak A, Kim S, Nam Y, Kim HS, Yoo DH, Moon M. Animal-Assisted and Pet-Robot Interventions for Ameliorating Behavioral and Psychological Symptoms of Dementia: A Systematic Review and Meta-Analysis. Biomedicines. 2020 Jun 2;8(6):150. doi: 10.3390/biomedicines8060150.
citation: Bernabei V, De Ronchi D, La Ferla T, Moretti F, Tonelli L, Ferrari B, Forlani M, Atti AR. Animal-assisted interventions for elderly patients affected by dementia or psychiatric disorders: a review. J Psychiatr Res. 2013 Jun;47(6):762-73. doi: 10.1016/j.jpsychires.2012.12.014. Epub 2013 Jan 29.
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.
citation: Castilla D, Suso-Ribera C, Zaragoza I, Garcia-Palacios A, Botella C. Designing ICTs for Users with Mild Cognitive Impairment: A Usability Study. Int J Environ Res Public Health. 2020 Jul 17;17(14):5153. doi: 10.3390/ijerph17145153.