AzTrials
AzTrials

Individuals With Multiple SclerosisNCT05341895

Kinesiotape on Balance in With Multiple Sclerosis

A study testing Kinesiotape in people with Individuals With Multiple Sclerosis and With Ataxia Symptoms, run by Firat University at 2 sites in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Kinesiotape
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesTurkey (Türkiye)
Study dates
22 Nov 2021to 6 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Furkan Bilek, Lecturer contact

+905442772249

fzt.furkanbilek@gmail.com

Turkey (Türkiye)2 sites, 2 recruiting
  • Furkan Bilek

    Elâzığ, 23100

    Furkan Bilek, 05442772249, fzt.furkanbilek@gmail.com

    Recruiting
  • Fırat university

    Elâzığ, 23100

    Furkan Bilek, Lecturer, 05442772249, fzt.furkanbilek@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Kinesiotape Applied on Paraspinal Muscles on Balance in Individuals With Multiple Sclerosis

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.

Read the 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.

Being tested
Kinesiotape
Keywords
Multiple Sclerosis, Balance, Ataxia, Kinesiotape
Medical subject headings
Multiple Sclerosis, Ataxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KinesiotapeOther

    Taping

Study groups in NCT05341895
Study groupRoleWhat they receive
kinesiotapeOtherKinesiotape applied to the paraspinal muscles
Receives: Other: Kinesiotape
PlaceboNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 week

  2. 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

    Measured: 1 week

  3. 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

    Measured: 1 week

Secondary outcomes (2)
  1. Functional Reach Test

    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

    Measured: 1 week

  2. Timed 25-Foot Walk

    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

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2022
  2. Study start22 Nov 2021
  3. Primary completion22 Apr 2022 (estimated)
  4. Study completion6 May 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Crossover
Model description
prospective
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05341895
Sponsor's protocol ID
Firat Un.
Status last verified
Apr 2022
First submitted
17 Apr 2022
Last updated
22 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16510748
  • 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.

    PubMed 25254633
  • 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.

    PubMed 33243182
  • 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.

    PubMed 28667904
  • 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.

    PubMed 27760859
  • 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.

    PubMed 20567946
  • 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.

    PubMed 17578750
  • 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.

    PubMed 16168933
  • 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.

    PubMed 17588814
  • 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.

    PubMed 24497814
  • 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.

    PubMed 20607815
  • 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.

    PubMed 1991946
  • 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.

    PubMed 17439905
  • 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.

    PubMed 35066275
  • 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.

    PubMed 34137673

Questions about this trial

What is this clinical trial studying?

A study testing Kinesiotape in people with Individuals With Multiple Sclerosis and With Ataxia Symptoms, run by Firat University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Furkan Bilek, Lecturer (+905442772249, fzt.furkanbilek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timed Up and Go Test (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05341895, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in