Multiple Sclerosis Clinical Trial
— KITAMSOfficial title:
KITAMS: Kinesio Tape and Physical Function in Persons With Multiples Sclerosis
Multiple sclerosis (MS) is a disease that causes damage within the central nervous system and results in deficits of body functions. The investigators propose a pilot randomized controlled trial examining the acute effect of kinesio tape application in various body segments on balance, mobility, physical functioning, and pain in persons with MS (pwMS) aged 18 to 55 years old. The investigators will objectively assess balance using a force platform and mobility and physical functioning will be assessed using standardized tests (i.e., Timed Up and Go, Timed 25-foot Walk, 6-minute Step Test, Six Spot Step Test). The trial will recruit 24 pwMS aged 18 to 55 years with mild-to-moderate MS-related disability who will be randomized into intervention (Kinesio Tape) or control conditions (Sham/Inflexible Tape). Participants will complete assessments before and after tape application. This pilot trial will inform future research interventions aiming to use the approach in different situations with pwMS (e.g., exercise).
Status | Recruiting |
Enrollment | 24 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - clinically definitive diagnosis of MS - aged 18 - 50 years - relapse-free for the past 30 days and - ability to walk with or without an assistive device (i.e., cane, but not walker/rollator). - must be willing to complete in-person assessments at a university research setting Exclusion Criteria: - use wheelchair, crutches and walker - have moderate cognitive impairment based on the modified Telephone Interview for Cognitive Status (i.e., moderate cognitive impairment, = 12 points). |
Country | Name | City | State |
---|---|---|---|
United States | Department of Kinesiology and Physical Education. Northern Illinois University | DeKalb | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northern Illinois University |
United States,
Álvarez-Álvarez S, José FG, Rodríguez-Fernández AL, Güeita-Rodríguez J, Waller BJ. Effects of Kinesio® Tape in low back muscle fatigue: randomized, controlled, doubled-blinded clinical trial on healthy subjects. J Back Musculoskelet Rehabil. 2014;27(2):203-12. doi: 10.3233/BMR-130437. — View Citation
Bove R, Musallam A, Healy BC, Houtchens M, Glanz BI, Khoury S, Guttmann CR, De Jager PL, Chitnis T. No sex-specific difference in disease trajectory in multiple sclerosis patients before and after age 50. BMC Neurol. 2013 Jul 3;13:73. doi: 10.1186/1471-2377-13-73. — View Citation
Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7. — View Citation
Cortesi M, Cattaneo D, Jonsdottir J. Effect of kinesio taping on standing balance in subjects with multiple sclerosis: A pilot study\m{1}. NeuroRehabilitation. 2011;28(4):365-72. doi: 10.3233/NRE-2011-0665. — View Citation
Dalmonte J, Finlayson M, Helfrich C. In their own words: coping processes among women aging with multiple sclerosis. Occup Ther Health Care. 2004;17(3-4):115-37. doi: 10.1080/J003v17n03_08. — View Citation
Dilorenzo T, Halper J, Picone MA. Reliability and validity of the multiple sclerosis quality of life inventory in older individuals. Disabil Rehabil. 2003 Aug 19;25(16):891-7. — View Citation
Finlayson M, Shevil E, Cho CC. Perceptions of cognitive symptoms among people aging with multiple sclerosis and their caregivers. Am J Occup Ther. 2009 Mar-Apr;63(2):151-9. — View Citation
Finlayson M, van Denend T. Experiencing the loss of mobility: perspectives of older adults with MS. Disabil Rehabil. 2003 Oct 21;25(20):1168-80. — View Citation
Finlayson M. Concerns about the future among older adults with multiple sclerosis. Am J Occup Ther. 2004 Jan-Feb;58(1):54-63. — View Citation
Ford CC BR. Effects of aging on the disease course and management of multiple sclerosis. Sci. MS Manag. 2015;4:1-13
Hsu YH, Chen WY, Lin HC, Wang WT, Shih YF. The effects of taping on scapular kinematics and muscle performance in baseball players with shoulder impingement syndrome. J Electromyogr Kinesiol. 2009 Dec;19(6):1092-9. doi: 10.1016/j.jelekin.2008.11.003. Epub 2009 Jan 14. — View Citation
Jones KH, Ford DV, Jones PA, John A, Middleton RM, Lockhart-Jones H, Peng J, Osborne LA, Noble JG. How people with multiple sclerosis rate their quality of life: an EQ-5D survey via the UK MS register. PLoS One. 2013 Jun 11;8(6):e65640. doi: 10.1371/journal.pone.0065640. Print 2013. — View Citation
Kilbreath SL, Perkins S, Crosbie J, McConnell J. Gluteal taping improves hip extension during stance phase of walking following stroke. Aust J Physiother. 2006;52(1):53-6. — View Citation
Kim MK, Cha HG. The effects of ankle joint taping on gait and balance ability of healthy adults. J Phys Ther Sci. 2015 Sep;27(9):2913-4. doi: 10.1589/jpts.27.2913. Epub 2015 Sep 30. — View Citation
Klaren RE, Sebastiao E, Chiu CY, Kinnett-Hopkins D, McAuley E, Motl RW. Levels and Rates of Physical Activity in Older Adults with Multiple Sclerosis. Aging Dis. 2016 May 27;7(3):278-84. doi: 10.14336/AD.2015.1025. eCollection 2016 May. — View Citation
Marrie RA, Yu N, Blanchard J, Leung S, Elliott L. The rising prevalence and changing age distribution of multiple sclerosis in Manitoba. Neurology. 2010 Feb 9;74(6):465-71. doi: 10.1212/WNL.0b013e3181cf6ec0. Epub 2010 Jan 13. Erratum in: Neurology. 2011 Sep 13;77(11):1105. — View Citation
Nam CW, Lee JH, Cho SH. The effect of non-elastic taping on balance and gait function in patients with stroke. J Phys Ther Sci. 2015 Sep;27(9):2857-60. doi: 10.1589/jpts.27.2857. Epub 2015 Sep 30. — View Citation
Petzold A, Eikelenboom MJ, Keir G, Grant D, Lazeron RH, Polman CH, Uitdehaag BM, Thompson EJ, Giovannoni G. Axonal damage accumulates in the progressive phase of multiple sclerosis: three year follow up study. J Neurol Neurosurg Psychiatry. 2005 Feb;76(2):206-11. — View Citation
Rojhani-Shirazi Z, Amirian S, Meftahi N. Effects of Ankle Kinesio Taping on Postural Control in Stroke Patients. J Stroke Cerebrovasc Dis. 2015 Nov;24(11):2565-71. doi: 10.1016/j.jstrokecerebrovasdis.2015.07.008. Epub 2015 Aug 29. — View Citation
Shirani A, Zhao Y, Petkau J, Gustafson P, Karim ME, Evans C, Kingwell E, van der Kop ML, Oger J, Tremlett H. Multiple sclerosis in older adults: the clinical profile and impact of interferon Beta treatment. Biomed Res Int. 2015;2015:451912. doi: 10.1155/2015/451912. Epub 2015 Apr 1. — View Citation
Thelen MD, Dauber JA, Stoneman PD. The clinical efficacy of kinesio tape for shoulder pain: a randomized, double-blinded, clinical trial. J Orthop Sports Phys Ther. 2008 Jul;38(7):389-95. doi: 10.2519/jospt.2008.2791. Epub 2008 May 29. — View Citation
Tintoré M, Alexander M, Costello K, Duddy M, Jones DE, Law N, O'Neill G, Uccelli A, Weissert R, Wray S. The state of multiple sclerosis: current insight into the patient/health care provider relationship, treatment challenges, and satisfaction. Patient Prefer Adherence. 2016 Dec 22;11:33-45. doi: 10.2147/PPA.S115090. eCollection 2017. — View Citation
Trojano M, Liguori M, Bosco Zimatore G, Bugarini R, Avolio C, Paolicelli D, Giuliani F, De Robertis F, Marrosu MG, Livrea P. Age-related disability in multiple sclerosis. Ann Neurol. 2002 Apr;51(4):475-80. — View Citation
* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Static Balance Performance | Center of Pressure (CoP) related measures collected from force plate | 10minutes | |
Primary | Timed and Up and Go | a measure of functional mobility | 6minutes | |
Primary | Timed 25-foot Walk | a measure of walking speed | 6minutes | |
Primary | Six-minute Walking Test | a measure of walking endurance | 10minutes | |
Primary | Six-spot Step Test | a measure of lower-body coordination | 6minutes | |
Primary | The Short Physical Performance Battery | represent a recently validity measure of physical function in persons with MS | 6minutes |
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