Kinesiotape on Balance in With Multiple Sclerosis
Primary Purpose
Individuals With Multiple Sclerosis, With Ataxia Symptoms, No Secondary Disease Affecting Balance
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesiotape
Sponsored by
About this trial
This is an interventional other trial for Individuals With Multiple Sclerosis focused on measuring Multiple Sclerosis, Balance, Ataxia, Kinesiotape
Eligibility Criteria
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
Sites / Locations
- Furkan BilekRecruiting
- Fırat universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
kinesiotape
Placebo
Arm Description
Kinesiotape applied to the paraspinal muscles
No intervention
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05341895
Brief Title
Kinesiotape on Balance in With Multiple Sclerosis
Official Title
The Effect of Kinesiotape Applied on Paraspinal Muscles on Balance in Individuals With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
April 22, 2022 (Anticipated)
Study Completion Date
May 6, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Firat University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Individuals With Multiple Sclerosis, With Ataxia Symptoms, No Secondary Disease Affecting Balance
Keywords
Multiple Sclerosis, Balance, Ataxia, Kinesiotape
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
prospective
Masking
None (Open Label)
Masking Description
The patient does not know the purpose of the kinesiotape
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
kinesiotape
Arm Type
Other
Arm Description
Kinesiotape applied to the paraspinal muscles
Arm Title
Placebo
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Kinesiotape
Intervention Description
Taping
Primary Outcome Measure Information:
Title
Timed Up and Go Test
Description
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
Time Frame
1 week
Title
Win-Track Analysis
Description
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
Time Frame
1 week
Title
3-meter Backward walk Test
Description
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
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Functional Reach Test
Description
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
Time Frame
1 week
Title
Timed 25-Foot Walk
Description
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
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Furkan Bilek, Lecturer
Phone
+905442772249
Email
fzt.furkanbilek@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caner F Demir, MD professor
Organizational Affiliation
Firat University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Furkan Bilek
City
Elazığ
ZIP/Postal Code
23100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Furkan Bilek
Phone
05442772249
Email
fzt.furkanbilek@gmail.com
Facility Name
Fırat university
City
Elazığ
ZIP/Postal Code
23100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Furkan Bilek, Lecturer
Phone
05442772249
Email
fzt.furkanbilek@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Kinesiotape on Balance in With Multiple Sclerosis
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