- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05341895
Kinesiotape on Balance in With Multiple Sclerosis
The Effect of Kinesiotape Applied on Paraspinal Muscles on Balance in Individuals With Multiple Sclerosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Multiple Sclerosis (MS), a chronic inflammatory disease of the central nervous system, is a disease characterized by myelin, oligodendrocyte and axon damage. Research continues on the autoimmune, infectious, environmental, vascular and genetic origins of this disease, which affects approximately 2.5 million people in the world and is seen 2-3 times more in women than in men. Although the signs and symptoms of the disease vary according to the location of the lesion; frequently, loss of strength, spasticity, sensory disturbances, fatigue, ataxia, autonomic dysfunction, and decreased visual acuity are observed.
Balance problems are seen in 50-80% of MS patients. Balance requires the controlled coordination of many central nervous system structures. Integration of vestibular, visual and somatosensory information is required to achieve and maintain balance. Vestibular ataxia occurs as a result of problems in the vestibular systems. These patients try to reduce head and eye movements as much as possible in order to maintain their balance. Symptoms arising from vestibular system dysfunction are seen in 49-59% of MS patients. symptoms; includes vertigo, drowsiness, and balance disorder. Somatosensory problems are seen in 80% of MS patients. Since the somatosensory system is one of the most fundamental factors in maintaining postural control and balance, sensory ataxia findings are frequently encountered in these patients due to the somatosensory system involvement. The most basic finding seen in these patients is that they perform many activities in daily life mostly using the visual system, since the information coming from the somatosensory system is not sufficient. The cerebellum and its efferent and afferent pathways are commonly affected in MS; and cerebellar ataxia is one of the most common symptoms especially in the progressive phase of the disease. Gait ataxia is thought to occur predominantly due to damage to the anterior lobe of the cerebellum. Trunk, extremity, or gait ataxia findings may occur singly and/or together, depending on the affected area of the cerebellum. balance dysfunction in MS patients; It is shaped mainly on the basis of three problems: decreased ability to maintain the existing position, a slow and limited movement towards the limits of stability, and delayed responses to postural displacements. In MS patients, functional balance performance is also affected in situations that require multitasking.
Kinesiotape is a relatively new method used in rehabilitation programs, and it is increasingly becoming an adjunctive treatment option for multidisciplinary rehabilitation in MS patients. It is a thin and elastic band that can stretch up to 120-140% of its original length. It is therefore highly elastic and causes fewer mechanism restrictions compared to the conventional tape. This technique normalizes muscle function, increases lymphatic and vascular flow, reduces pain, strengthens weakened muscles, and helps with postural alignment by relaxing overused muscles. It has been claimed that the effects of kinesiotape may result from sensorimotor and proprioceptive feedback mechanisms. Kinesiotape provides rapid sensorimotor feedback: patients usually report relief of symptoms, increased comfort level, or stability of the involved joint within a few days. Kinesiotape may be an alternative rehabilitation option when a rapid effect is required in the treatment of MS. However, more clinical and neurophysiological studies are needed to clarify the mechanism of action and effects of the Kinesiotape technique.
With these approaches, the effect of Kinesiotape application on balance will be investigated in individuals with ataxic MS. Based on this idea, our work; It was planned to investigate the effect of kinesiotape application on balance in individuals diagnosed with ataxic multiple sclerosis.
In our study, patients diagnosed with MS by a neurologist at Fırat University Hospital will be evaluated.
From patient records, demographic characteristics; patients' age, gender, body weight, height, EDSS score, occupation and educational status, history of the disease; The MS type will be registered. To our neurological evaluation form; reflexes, sensory defects, cranial nerve lesion, visual disturbances, speech problems, balance and functional status will be obtained.
With these data, the effects of Kinesiotape application on the balance status of patients will be investigated.
Functional Reach Test, Timed Get Up and Go Test, 25 Steps Walk Test, 3 Meter backward walking Test and Win-Track walking platform evaluation data will be taken from the participants.
Statistical analyzes of the study will be done with "Statistical Package for Social Sciences" (SPSS) Version IBM Statistic 20. Demographic data will be given as mean ± SD. Students t test will be used in continuous variables analysis and Chi-square test will be used in comparison of percentages. Differences below a P value <0.05 will be considered significant.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Furkan Bilek, Lecturer
- Phone Number: +905442772249
- Email: fzt.furkanbilek@gmail.com
Study Locations
-
-
-
Elazığ, Turkey, 23100
- Recruiting
- Fırat university
-
Contact:
- Furkan Bilek, Lecturer
- Phone Number: 05442772249
- Email: fzt.furkanbilek@gmail.com
-
Elazığ, Turkey, 23100
- Recruiting
- Furkan Bilek
-
Contact:
- Furkan Bilek
- Phone Number: 05442772249
- Email: fzt.furkanbilek@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- with ataxia symptoms with a diagnosis of multiple sclerosis No attacks in the last 3 months
Exclusion Criteria:
- Having other illnesses that may affect the balance allergic to kinesiotape
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Placebo
No intervention
|
|
|
Other: kinesiotape
Kinesiotape applied to the paraspinal muscles
|
Taping
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go Test
Time Frame: 1 week
|
It is applied to evaluate the balance and fall risk of individuals.
The patient is first asked to sit leaning on the chair.
The patient is then asked to stand up, walk with regular steps for a predetermined distance of 3 meters, return at the end of 3 meters and sit in a chair.
During the test, the patient's walking time is recorded in seconds with a stopwatch.
The test was repeated three times and the mean value will be recorded
|
1 week
|
|
Win-Track Analysis
Time Frame: 1 week
|
With the pressure measurement platform, static and dynamic pressure distributions, motion cycles, pressure, power, time and step parameters, as well as gait symmetry analysis data will be taken from the system
|
1 week
|
|
3-meter Backward walk Test
Time Frame: 1 week
|
The 3-meter distance is marked with a black tape and participants are asked to align their heels with the black tape.
Individuals are asked to walk backwards as soon as possible with the "walk" command and stop when they reach 3 meters.
Meanwhile, the elapsed time is recorded in seconds.
Evaluation will be done three times and the average time will be recorded
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Reach Test
Time Frame: 1 week
|
The FRT is a clinical assessment tool of balance and requires only a flattened measuring stick attached to the wall at the height of the participant's right acromion.
In the test, a participant stands comfortably with their feet approximately shoulder-width apart and positions their preferred arm closest to the wall at 90° shoulder flexion.
They reach as far as possible without falling and stepping.
The examiner records the position of the distal ends of the finger in the starting position and the ending position, and the distance is the difference between the two positions, measured in cm
|
1 week
|
|
Timed 25-Foot Walk
Time Frame: 1 week
|
The 25-Step Walking Test is a test that measures lower extremity functions.
It has been developed for the purpose of recording the patient with this test at each examination.
The patient is asked to walk in a predetermined interval.
The average of both times is taken by noting the number of seconds spent on the way out and on the way back
|
1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Caner F Demir, MD professor, Firat University
Publications and helpful links
General Publications
- Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
- Fu TC, Wong AM, Pei YC, Wu KP, Chou SW, Lin YC. Effect of Kinesio taping on muscle strength in athletes-a pilot study. J Sci Med Sport. 2008 Apr;11(2):198-201. doi: 10.1016/j.jsams.2007.02.011. Epub 2007 Jun 27.
- Halseth T, McChesney JW, Debeliso M, Vaughn R, Lien J. The effects of kinesio taping on proprioception at the ankle. J Sports Sci Med. 2004 Mar 1;3(1):1-7. eCollection 2004 Mar.
- Goodman AD, Cohen JA, Cross A, Vollmer T, Rizzo M, Cohen R, Marinucci L, Blight AR. Fampridine-SR in multiple sclerosis: a randomized, double-blind, placebo-controlled, dose-ranging study. Mult Scler. 2007 Apr;13(3):357-68. doi: 10.1177/1352458506069538. Epub 2007 Jan 29.
- Yoshida A, Kahanov L. The effect of kinesio taping on lower trunk range of motions. Res Sports Med. 2007 Apr-Jun;15(2):103-12. doi: 10.1080/15438620701405206.
- Marsden J, Pavlou M, Dennett R, Gibbon A, Knight-Lozano R, Jeu L, Flavell C, Freeman J, Bamiou DE, Harris C, Hawton A, Goodwin E, Jones B, Creanor S. Vestibular rehabilitation in multiple sclerosis: study protocol for a randomised controlled trial and cost-effectiveness analysis comparing customised with booklet based vestibular rehabilitation for vestibulopathy and a 12 month observational cohort study of the symptom reduction and recurrence rate following treatment for benign paroxysmal positional vertigo. BMC Neurol. 2020 Nov 27;20(1):430. doi: 10.1186/s12883-020-01983-y.
- Frohman EM, Racke MK, Raine CS. Multiple sclerosis--the plaque and its pathogenesis. N Engl J Med. 2006 Mar 2;354(9):942-55. doi: 10.1056/NEJMra052130. No abstract available.
- Cameron MH, Lord S. Postural control in multiple sclerosis: implications for fall prevention. Curr Neurol Neurosci Rep. 2010 Sep;10(5):407-12. doi: 10.1007/s11910-010-0128-0.
- Mazumder R, Murchison C, Bourdette D, Cameron M. Falls in people with multiple sclerosis compared with falls in healthy controls. PLoS One. 2014 Sep 25;9(9):e107620. doi: 10.1371/journal.pone.0107620. eCollection 2014.
- Bilek F, Demir CF. Validity and reliability of the 3-meter backward walk test in mildly disabled persons with multiple sclerosis. Mult Scler Relat Disord. 2022 Feb;58:103532. doi: 10.1016/j.msard.2022.103532. Epub 2022 Jan 19.
- Jamali A, Sadeghi-Demneh E, Fereshtenajad N, Hillier S. Somatosensory impairment and its association with balance limitation in people with multiple sclerosis. Gait Posture. 2017 Sep;57:224-229. doi: 10.1016/j.gaitpost.2017.06.020. Epub 2017 Jun 24.
- D'Ambrosio A, Pagani E, Riccitelli GC, Colombo B, Rodegher M, Falini A, Comi G, Filippi M, Rocca MA. Cerebellar contribution to motor and cognitive performance in multiple sclerosis: An MRI sub-regional volumetric analysis. Mult Scler. 2017 Aug;23(9):1194-1203. doi: 10.1177/1352458516674567. Epub 2016 Oct 19.
- Kesselring J, Beer S. Symptomatic therapy and neurorehabilitation in multiple sclerosis. Lancet Neurol. 2005 Oct;4(10):643-52. doi: 10.1016/S1474-4422(05)70193-9.
- Lin JJ, Hung CJ, Yang PL. The effects of scapular taping on electromyographic muscle activity and proprioception feedback in healthy shoulders. J Orthop Res. 2011 Jan;29(1):53-7. doi: 10.1002/jor.21146.
- Soke F, Eldemir S, Ozkan T, Ozkul C, Ozcan Gulsen E, Gulsen C, Eldemir K, Irkec C, Bilge Gonenli K, Batur Caglayan HZ, Guclu-Gunduz A. The functional reach test in people with multiple sclerosis: a reliability and validity study. Physiother Theory Pract. 2022 Nov;38(13):2905-2919. doi: 10.1080/09593985.2021.1938308. Epub 2021 Jun 17.
- Ramachandra P, Maiya AG, Kumar P. Test-retest reliability of the Win-Track platform in analyzing the gait parameters and plantar pressures during barefoot walking in healthy adults. Foot Ankle Spec. 2012 Oct;5(5):306-12. doi: 10.1177/1938640012457680. Epub 2012 Sep 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Firat Un.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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