Local Vibration in Multiple Sclerosis Patients

NCT ID: NCT04192786

Last Updated: 2020-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-15

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment Group 50 Hz

Group Type EXPERIMENTAL

Standard physiotherapy program+50 Hz local vibration

Intervention Type OTHER

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.

Treatment Group 100 Hz

Group Type EXPERIMENTAL

Standard physiotherapy program+100 Hz local vibration

Intervention Type OTHER

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.

Control Group

Group Type ACTIVE_COMPARATOR

Standard physiotherapy program

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Standard physiotherapy program

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Ayvat

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Altındağ, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Fatma Ayvat, MSc

Role: CONTACT

+905514252059

Facility Contacts

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Muhammed Kılınç, Assoc. Prof.

Role: primary

+905326418381

References

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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.

Reference Type DERIVED
PMID: 33836458 (View on PubMed)

Other Identifiers

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KA-19018

Identifier Type: -

Identifier Source: org_study_id

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