Local Vibration in Multiple Sclerosis Patients

NCT04192786 | Unknown DMC

• 1 other identifier: KA-19018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Spasticity; Local Vibration; Muscle Architecture; Functionality

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Assessment of spasticity

  5 minutes

• Assessment of viscoelastic properties of muscle

  5 minutes

• Assessment of ankle proprioception

  5 minutes

• Assessment of single leg balance

  3 minutes

• Assessment of balance

  10 minutes

Study Arms (3)

Treatment Group 50 Hz

EXPERIMENTAL

Other: Standard physiotherapy program+50 Hz local vibration

Treatment Group 100 Hz

EXPERIMENTAL

Other: Standard physiotherapy program+100 Hz local vibration

Control Group

ACTIVE COMPARATOR

Other: Standard physiotherapy program

Interventions

Standard physiotherapy program+50 Hz local vibration OTHER

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.

Treatment Group 50 Hz

Standard physiotherapy program+100 Hz local vibration OTHER

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.

Treatment Group 100 Hz

Standard physiotherapy program OTHER

Standard physiotherapy program (strength, balance, gait exercises) for 60 minutes will be performed 3 days a week for 8 weeks.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years
• EDSS\<5,5
• Gastrocnemius spasticity\<2

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Altındağ, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 33836458 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fatma Ayvat, MSc

CONTACT

+905514252059; fatma.avcu@hacettepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 10, 2019
• Study Start: December 15, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)