Local Vibration in Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04192786
• Other study ID #: KA-19018
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2019
• Est. completion date: December 2020

Study information

• Verified date: June 2020
• Source: Hacettepe University
• Contact: Fatma Ayvat, MSc
• Phone: +905514252059
• Email: fatma.avcu[@]hacettepe.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Turkey	Hacettepe University, Faculty of Physical Therapy and Rehabilitation	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Assessment of spasticity	Modified Ashworth Scale (minimum score 0 (worse), maximum score 4 (better))	5 minutes
Secondary	Assessment of viscoelastic properties of muscle	Myoton-3 (assessment of tone, elasticity and stiffness)	5 minutes
Secondary	Assessment of ankle proprioception	Isokinetic dynamometer (Isomed 2000) (passive ankle joint position sense)	5 minutes
Secondary	Assessment of single leg balance	Single leg balance test	3 minutes
Secondary	Assessment of balance	Bertec Balance Check ScreenerTM force platform system (Assessment of limits of stability, anteroposterior and mediolateral sway range)	10 minutes
Secondary	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