Local Vibration in Multiple Sclerosis Patients

Sponsor

Hacettepe University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04192786

Collaborator

(none)

Enrollment

Location

Arms

11.6

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: Standard physiotherapy program+50 Hz local vibration Other: Standard physiotherapy program+100 Hz local vibration Other: Standard physiotherapy program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 15, 2019

Anticipated Primary Completion Date :

Nov 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Evaluation of Muscle Thickness and Fascicle Length with Ultrasonography [3 minutes]
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.
Evaluation of Pennation Angle with Ultrasonography [2 minutes]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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