Clinical trial NCT04192786: Local Vibration in Multiple Sclerosis Patients
Official title: The Effect of Local Vibration Applied to Spastic Gastrocnemius on Muscle Architecture and Functional Properties in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Spasticity
Local Vibration
Muscle Architecture
Functionality
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of Muscle Thickness and Fascicle Length with Ultrasonography
timeFrame: 3 minutes
measure: Evaluation of Pennation Angle with Ultrasonography
timeFrame: 2 minutes
Secondary outcomes:
measure: Assessment of spasticity
timeFrame: 5 minutes
measure: Assessment of viscoelastic properties of muscle
timeFrame: 5 minutes
measure: Assessment of ankle proprioception
timeFrame: 5 minutes
measure: Assessment of single leg balance
timeFrame: 3 minutes
measure: Assessment of balance
timeFrame: 10 minutes
measure: Assessment of gait characterictics
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation
state: Altındağ
Study officials:
References:
citation: 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.