- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04289129
The Viscoelastic Properties of Lower Extremity's Muscles
December 14, 2020 updated by: Serkan Usgu, Hasan Kalyoncu University
The Mechanical Characteristics of Lower Extremity Muscles in Healthy Individuals Using Myotonometric Assessment
This study aims to create normative values for stiffness, tonus and elasticity in the lower extremity muscles and to determine age and gender differences.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
389
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gaziantep, Turkey
- Hasan Kalyoncu University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Individuals without any systemic or metabolic diseases, psychological illnesses, or drug abuse; those without any diseases that could cause muscle disease or muscle atrophy; and those who had not undergone any surgery in the musculoskeletal system during the past 3 months were included
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: men
|
Vertically placed on the muscle, a probe (3 mm diameter) creates constant pre-excitations (0.18 N) and generates short-term (15 ms), low-force (0.4 N) mechanical stimulations.
|
Experimental: women
|
Vertically placed on the muscle, a probe (3 mm diameter) creates constant pre-excitations (0.18 N) and generates short-term (15 ms), low-force (0.4 N) mechanical stimulations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myotonometric evaluation
Time Frame: 1 year
|
The muscle tone, stiffness and elasticity of participants are assessed with myoton device for creating normative data
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Correa-de-Araujo R, Harris-Love MO, Miljkovic I, Fragala MS, Anthony BW, Manini TM. The Need for Standardized Assessment of Muscle Quality in Skeletal Muscle Function Deficit and Other Aging-Related Muscle Dysfunctions: A Symposium Report. Front Physiol. 2017 Feb 15;8:87. doi: 10.3389/fphys.2017.00087. eCollection 2017.
- Perkisas, S., et al., Physiological and architectural changes in the ageing muscle and their relation to strength and function in sarcopenia. European Geriatric Medicine, 2016. 7(3): p. 201-206
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2018
Primary Completion (Actual)
January 12, 2019
Study Completion (Actual)
February 20, 2020
Study Registration Dates
First Submitted
February 23, 2020
First Submitted That Met QC Criteria
February 26, 2020
First Posted (Actual)
February 28, 2020
Study Record Updates
Last Update Posted (Actual)
December 17, 2020
Last Update Submitted That Met QC Criteria
December 14, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2019-61
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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