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Clinical Trials/NCT04192786
NCT04192786UnknownNot Applicable

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

Hacettepe University1 site in 1 country30 target enrollmentStarted: December 15, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Locations
1
Primary Endpoint
Evaluation of Muscle Thickness and Fascicle Length with Ultrasonography

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Treatment Group 50 Hz

Experimental

Intervention: Standard physiotherapy program+50 Hz local vibration (Other)

Treatment Group 100 Hz

Experimental

Intervention: Standard physiotherapy program+100 Hz local vibration (Other)

Control Group

Active Comparator

Intervention: Standard physiotherapy program (Other)

Outcomes

Primary Outcomes

Evaluation of Muscle Thickness and Fascicle Length with Ultrasonography

Time Frame: 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

Time Frame: 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 Outcomes

  • Assessment of gait characterictics(5 minutes)
  • Assessment of single leg balance(3 minutes)
  • Assessment of balance(10 minutes)
  • Assessment of spasticity(5 minutes)
  • Assessment of viscoelastic properties of muscle(5 minutes)
  • Assessment of ankle proprioception(5 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fatma Ayvat

Research Assistant

Hacettepe University

Study Sites (1)

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