Gait Analysis in Multiple Sclerosis Patients

Study Overview
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Brief Summary
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In the literature, the results of vestibular rehabilitation treatment applied in patients with Multiple Sclerosis (MS) have been investigated in detail under the headings such as fatigue, physical activity level, and quality of life, and its effects on walking have also been tried to be examined. However, in the studies conducted, gait assessments were made through questionnaires and timed tests, and devices that provide more objective data such as 3-dimensional gait analysis were not used. Again, the effects of vestibular rehabilitation programs on dual-task were not examined in previous studies. Therefore, the aims of our study are: To determine the effect of individually designed vestibular rehabilitation exercises on the kinetic and kinematic components of walking; To determine the effect of vestibular rehabilitation exercises specially designed for the person on gait parameters during cognitive and motor tasks.

Official Title
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The Effect of Vestibular Rehabilitation on the Kinetic and Kinematic Parameters of Walking in Patients With Multiple Sclerosis

Conditions
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Multiple Sclerosis, 3D Gait Analysis, Vestibular Rehabilitation

Intervention / Treatment
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* Other: Vestibular exercises
* Other: Standard neurorehabilitation exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between aged 25-60 years Diagnosed with MS for at least 5 years Relapsing and progressive MS according to Mc Donald criteria EDSS score of ≤ 3.5 ≤ 6 Modified Ashworth Scale < 3 Being eligible to work by a neurologist Exclusion Criteria: Having had an MS-related attack in the 3 months before the study Changes in medications within 6 months prior to the study To have participated in the rehabilitation program within 1 month before the study Serious neurological, cardiac, pulmonary, rheumatological, audiovisual, or orthopedic disorders that limit assessments and/or intervention programs

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vestibular Rehabilitation Group<br>A vestibular rehabilitation exercise program, which is determined based on the literature and personalized according to the functional disabilities of each patient, will be applied to the participants in the experimental group. An exercise session will be performed for a total of 40 minutes, with each exercise for 1-2 minutes. Exercise training will be applied 2 days a week for 8 weeks and they will be asked to do it at home once a week. | Other: Vestibular exercises<br>* The vestibular exercise program basically consists of 3 groups of exercises: adaptation, substitution, and habituation exercises. It is aimed to provide vestibular adaptation with adaptation exercises. Exercises that include visual and somatosensory cues to improve gaze and postural stability constitute substitution exercises. Balance exercises can be performed with eyes open and closed, or somatosensory cues can be changed by performing them on soft ground. Removing or reducing clues allows the patient to use other systems as well. The basis of habituation exercises is the reduction of the pathological response as a result of repeated exposure to the provocative stimulus. Habituation is specific to the type, intensity, and direction of stimuli. In most cases, the movement that stimulates the pathological response is less frequently performed during daily activities and promotes compensation for the initially abnormal signal of treatment.<br>|
| Active Comparator: Standard Neurorehabilitation Group<br>A neurorehabilitation program based on stretching, strengthening, posture, mobilization, static and dynamic balance exercises will be applied. Each training session will be 40 minutes in total. Exercise training will be done in the clinical setting 2 days a week for 8 weeks, and they will be asked to do it at home once a week. | Other: Standard neurorehabilitation exercises<br>* A neurorehabilitation program based on stretching, strengthening, posture, mobilization, static and dynamic balance exercises (standing on one leg, tandem, balance board, etc.) will be applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D Gait Analysis System - pre assesment | Kinetic and kinematic data of gait will be collected in the motion analysis laboratory using 6 infrared digital cameras (Vantage 5.0), 2 synchronized video cameras (Vicon Vue) and 2 force platforms (AMTI). | It will be done at the beginning of the study. An analysis session lasts nearly 2 hours per patient. Evaluation of all participants will take approximately 2 months. | 
| 3D Gait Analysis System - post assesment | Kinetic and kinematic data of gait will be collected in the motion analysis laboratory using | It will be done at the end of the study. An analysis session lasting nearly 2 hours per patient. Evaluation of all participants will take approximately 2 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One Leg Standing Test - pre assesment | It will be used to determine the patient's standing balance. The duration of standing on one leg will be recorded with a stopwatch and 3 repetitions will be taken and the most successful score will be used in the analysis. | It will be done at the beginning of the study. The test lasts nearly 5 minutes. | 
| One Leg Standing Test - post assessment | It will be used to determine the patient's standing balance. The duration of standing on one leg will be recorded with a stopwatch and 3 repetitions will be taken and the most successful score will be used in the analysis. | It will be done at the end of the study. The test lasts nearly 5 minutes. | 
| Dizziness Handicap Inventory - pre assessment | The Dizziness Disability Inventory consists of 25 items that determine the aggravating factors of patients' dizziness and balance disorder, as well as emotional and functional outcomes in vestibular system diseases. It includes 9 items that determine emotional and functional status, and seven items that determine physical function. | It will be done at the beginning of the study. The test lasts nearly 15 minutes. | 
| Dizziness Handicap Inventory - post assessment | The Dizziness Disability Inventory consists of 25 items that determine the aggravating factors of patients' dizziness and balance disorder, as well as emotional and functional outcomes in vestibular system diseases. It includes 9 items that determine emotional and functional status, and seven items that determine physical function. | It will be done at the end of the study. The test lasts nearly 15 minutes. | 
| 2 Minute Walking Test - pre assessment | The distance that patients will walk for 2 minutes will be measured and recorded. | It will be done at the beginning of the study. The test lasts nearly 5 minutes. | 
| 2 Minute Walking Test - post assessment | The distance that patients will walk for 2 minutes will be measured and recorded. | It will be done at the end of the study. The test lasts nearly 5 minutes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gait analysis, multiple sclerosis, vestibular, kinetic, kinematic