Local Vibration in Multiple Sclerosis Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Standard physiotherapy program+50 Hz local vibration; Other: Standard physiotherapy program+100 Hz local vibration; Other: Standard physiotherapy program

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Altındağ
    • Ankara, Altındağ, Turkey, 06100
      • Recruiting
      • Hacettepe University, Faculty of Physical Therapy and Rehabilitation
      • Contact: Muhammed Kılınç, Assoc. Prof.; Phone Number: +905326418381; Email: muhammedkilinc@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment Group 50 Hz	Other: Standard physiotherapy program+50 Hz local vibration; 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.
EXPERIMENTAL: Treatment Group 100 Hz	Other: Standard physiotherapy program+100 Hz local vibration; 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.
ACTIVE_COMPARATOR: Control Group	Other: Standard physiotherapy program; Standard physiotherapy program (strength, balance, gait exercises) for 60 minutes will be performed 3 days a week for 8 weeks.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hacettepe University

Publications and helpful links

General Publications

• Ayvat F, Ozcakar L, Ayvat E, Aksu Yildirim S, Kilinc M. Effects of low vs. high frequency local vibration on mild-moderate muscle spasticity: Ultrasonographical and functional evaluation in patients with multiple sclerosis. Mult Scler Relat Disord. 2021 Jun;51:102930. doi: 10.1016/j.msard.2021.102930. Epub 2021 Mar 31.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 15, 2019
• Primary Completion (ANTICIPATED): November 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: December 7, 2019
• First Posted (ACTUAL): December 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Functionality; Spasticity; Muscle Architecture; Local Vibration
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: KA-19018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No