Local Vibration in Multiple Sclerosis Patients
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Standard physiotherapy program+50 Hz local vibration
Standard physiotherapy program+100 Hz local vibration
Standard physiotherapy program
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Spasticity, Local Vibration, Muscle Architecture, Functionality
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
Sites / Locations
- Hacettepe University, Faculty of Physical Therapy and RehabilitationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Treatment Group 50 Hz
Treatment Group 100 Hz
Control Group
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Assessment of spasticity
Modified Ashworth Scale (minimum score 0 (worse), maximum score 4 (better))
Assessment of viscoelastic properties of muscle
Myoton-3 (assessment of tone, elasticity and stiffness)
Assessment of ankle proprioception
Isokinetic dynamometer (Isomed 2000) (passive ankle joint position sense)
Assessment of single leg balance
Single leg balance test
Assessment of balance
Bertec Balance Check ScreenerTM force platform system (Assessment of limits of stability, anteroposterior and mediolateral sway range)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04192786
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2019 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Spasticity, Local Vibration, Muscle Architecture, Functionality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group 50 Hz
Arm Type
Experimental
Arm Title
Treatment Group 100 Hz
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Standard physiotherapy program+50 Hz local vibration
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard physiotherapy program+100 Hz local vibration
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard physiotherapy program
Intervention Description
Standard physiotherapy program (strength, balance, gait exercises) for 60 minutes will be performed 3 days a week for 8 weeks.
Primary Outcome Measure Information:
Title
Evaluation of Muscle Thickness and Fascicle Length with Ultrasonography
Description
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.
Time Frame
3 minutes
Title
Evaluation of Pennation Angle with Ultrasonography
Description
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.
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Assessment of spasticity
Description
Modified Ashworth Scale (minimum score 0 (worse), maximum score 4 (better))
Time Frame
5 minutes
Title
Assessment of viscoelastic properties of muscle
Description
Myoton-3 (assessment of tone, elasticity and stiffness)
Time Frame
5 minutes
Title
Assessment of ankle proprioception
Description
Isokinetic dynamometer (Isomed 2000) (passive ankle joint position sense)
Time Frame
5 minutes
Title
Assessment of single leg balance
Description
Single leg balance test
Time Frame
3 minutes
Title
Assessment of balance
Description
Bertec Balance Check ScreenerTM force platform system (Assessment of limits of stability, anteroposterior and mediolateral sway range)
Time Frame
10 minutes
Title
Assessment of gait characterictics
Description
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)
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma Ayvat, MSc
Phone
+905514252059
Email
fatma.avcu@hacettepe.edu.tr
Facility Information:
Facility Name
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
City
Ankara
State/Province
Altındağ
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammed Kılınç, Assoc. Prof.
Phone
+905326418381
Email
muhammedkilinc@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33836458
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.
Results Reference
derived
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Local Vibration in Multiple Sclerosis Patients
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