NCT05341895

Brief Summary

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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

April 17, 2022

Last Update Submit

April 17, 2022

Conditions

Keywords

Multiple SclerosisBalanceAtaxiaKinesiotape

Outcome Measures

Primary Outcomes (3)

  • Timed Up and Go Test

    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

    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

    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 Outcomes (2)

  • Functional Reach Test

    1 week

  • Timed 25-Foot Walk

    1 week

Study Arms (2)

kinesiotape

OTHER

Kinesiotape applied to the paraspinal muscles

Other: Kinesiotape

Placebo

NO INTERVENTION

No intervention

Interventions

Taping

kinesiotape

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • with ataxia symptoms with a diagnosis of multiple sclerosis No attacks in the last 3 months

You may not qualify if:

  • Having other illnesses that may affect the balance allergic to kinesiotape

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Furkan Bilek

Elâzığ, 23100, Turkey (Türkiye)

RECRUITING

Fırat university

Elâzığ, 23100, Turkey (Türkiye)

RECRUITING

Related Publications (16)

  • 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.

    PMID: 16510748BACKGROUND
  • 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.

    PMID: 25254633BACKGROUND
  • 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.

    PMID: 33243182BACKGROUND
  • 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.

    PMID: 28667904BACKGROUND
  • 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.

    PMID: 27760859BACKGROUND
  • 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.

    PMID: 20567946BACKGROUND
  • 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.

    PMID: 17578750BACKGROUND
  • 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.

    PMID: 16168933BACKGROUND
  • 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.

    PMID: 17588814BACKGROUND
  • 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.

    PMID: 24497814BACKGROUND
  • 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.

    PMID: 20607815BACKGROUND
  • 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.

    PMID: 1991946BACKGROUND
  • 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.

    PMID: 17439905BACKGROUND
  • 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.

    PMID: 35066275BACKGROUND
  • 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.

    PMID: 34137673BACKGROUND
  • 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.

    PMID: 22956663BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisAtaxia

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Caner F Demir, MD professor

    Firat University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Furkan Bilek, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
The patient does not know the purpose of the kinesiotape
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: prospective
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 17, 2022

First Posted

April 22, 2022

Study Start

November 22, 2021

Primary Completion

April 22, 2022

Study Completion

May 6, 2022

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations