Local Vibration in Multiple Sclerosis Patients

Study Overview
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Brief Summary
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Gastrocnemius spasticity is one of the main complaints in Multiple Sclerosis patients.Local muscle vibration is a method used for spasticity inhibition. However, when the studies in the literature are examined; It is noted that local vibration applications for spasticity are usually single sessions and evaluate the acute effect, do not produce functional outputs, there is no consensus on frequency and amplitude and the changes in muscle architecture are not examined. In this study, we aimed to investigate the effect of local vibration applied on spastic gastrocnemius on muscle architectural and functional properties in Multiple Sclerosis patients in addition to the standard physiotherapy program. The study was planned to include 3 groups, 2 treatment and 1 control group. The control group will receive standard physiotherapy, one of the treatment groups will receive 50 Hz local vibration in addition to standard physiotherapy, and other treatment group will receive 100 Hz local vibration in addition to standard physiotherapy. Disease severity, gastrocnemius spasticity, architectural and viscoelastic properties of muscle, ankle proprioception, balance and gait skills will be evaluated before and after 8 weeks treatment program. As a result; effectiveness of local vibration in addition to standard physiotherapy program and whether there is a difference between applications at different frequencies will be examined.

Official Title
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The Effect of Local Vibration Applied to Spastic Gastrocnemius on Muscle Architecture and Functional Properties in Multiple Sclerosis Patients

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Standard physiotherapy program+50 Hz local vibration
* Other: Standard physiotherapy program+100 Hz local vibration
* Other: Standard physiotherapy program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years EDSS<5,5 Gastrocnemius spasticity<2 Exclusion Criteria: having any injury or surgery of the lower extremity having systemic and metabolic disease having behavioral and cognitive problems that prevent consistence to guidelines given

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group 50 Hz<br> | Other: Standard physiotherapy program+50 Hz local vibration<br>* Standard physiotherapy program (strength, balance, gait exercises) for 50 minutes and local vibration applied to gastrocnemius (50 Hz) for 10 minutes will be performed 3 days a week for 8 weeks.<br>|
| Experimental: Treatment Group 100 Hz<br> | Other: Standard physiotherapy program+100 Hz local vibration<br>* Standard physiotherapy program (strength, balance, gait exercises) for 50 minutes and local vibration applied to gastrocnemius (100 Hz) for 10 minutes will be performed 3 days a week for 8 weeks.<br>|
| Active Comparator: Control Group<br> | Other: Standard physiotherapy program<br>* Standard physiotherapy program (strength, balance, gait exercises) for 60 minutes will be performed 3 days a week for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Muscle Thickness and Fascicle Length with Ultrasonography | Bilateral Medial Gastrocnemius US evaluations were performed with use of a 5-10 MHz linear probe (Diasus Dynamic Imaging Ltd, Livingston, Scotland,UK). Patients were positioned prone position with their legs and their muscles relaxed for medial gastrocnemius. Muscle Thickness and Fascicle Length would be expressed as centimeters. | 3 minutes | 
| Evaluation of Pennation Angle with Ultrasonography | Bilateral Medial Gastrocnemius US evaluations were performed with use of a 5-10 MHz linear probe (Diasus Dynamic Imaging Ltd, Livingston, Scotland,UK). Patients were positioned prone position with their legs and their muscles relaxed for medial gastrocnemius. Pennation Angle would be angularly indicated. | 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of spasticity | Modified Ashworth Scale (minimum score 0 (worse), maximum score 4 (better)) | 5 minutes | 
| Assessment of viscoelastic properties of muscle | Myoton-3 (assessment of tone, elasticity and stiffness) | 5 minutes | 
| Assessment of ankle proprioception | Isokinetic dynamometer (Isomed 2000) (passive ankle joint position sense) | 5 minutes | 
| Assessment of single leg balance | Single leg balance test | 3 minutes | 
| Assessment of balance | Bertec Balance Check ScreenerTM force platform system (Assessment of limits of stability, anteroposterior and mediolateral sway range) | 10 minutes | 
| Assessment of gait characterictics | GAITRite Analysis System (assessment of velocity, step length, percentage of gait cycle spent in double and single support, stance phase, swing phase, base of support) | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Spasticity, Local Vibration, Muscle Architecture, Functionality