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Kinesiotape on Balance in With Multiple Sclerosis

Sponsor
Firat University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05341895
Collaborator
(none)
60
Enrollment
2
Locations
2
Arms
5.4
Anticipated Duration (Months)
30
Patients Per Site
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Kinesiotape
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
prospectiveprospective
Masking:
None (Open Label)
Masking Description:
The patient does not know the purpose of the kinesiotape
Primary Purpose:
Other
Official Title:
The Effect of Kinesiotape Applied on Paraspinal Muscles on Balance in Individuals With Multiple Sclerosis
Actual Study Start Date :
Nov 22, 2021
Anticipated Primary Completion Date :
Apr 22, 2022
Anticipated Study Completion Date :
May 6, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: kinesiotape

Kinesiotape applied to the paraspinal muscles

Other: Kinesiotape
Taping
No Intervention: Placebo

No intervention

Outcome Measures

Primary Outcome Measures

  1. Timed Up and Go Test [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

  2. Win-Track Analysis [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

  3. 3-meter Backward walk Test [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

Secondary Outcome Measures

  1. Functional Reach Test [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

  2. Timed 25-Foot Walk [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Furkan Bilek Elazığ Turkey 23100
2 Fırat university Elazığ Turkey 23100

Sponsors and Collaborators

  • Firat University

Investigators

  • Principal Investigator: Caner F Demir, MD professor, Firat University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Furkan BİLEK, Lecturer, Firat University
ClinicalTrials.gov Identifier:
NCT05341895
Other Study ID Numbers:
  • Firat Un.
First Posted:
Apr 22, 2022
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Furkan BİLEK, Lecturer, Firat University
Multiple Sclerosis
Balance
Ataxia
Kinesiotape
Additional relevant MeSH terms:
Multiple Sclerosis
Ataxia
Sclerosis

Study Results

No Results Posted as of Apr 22, 2022