NCT04289129

Brief Summary

This study aims to create normative values for stiffness, tonus and elasticity in the lower extremity muscles and to determine age and gender differences.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
389

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

7 months

First QC Date

February 23, 2020

Last Update Submit

December 14, 2020

Conditions

Muscle Loss

Keywords

Muscle toneviscoelastic propertiesaging

Outcome Measures

Primary Outcomes (1)

  • Myotonometric evaluation

    The muscle tone, stiffness and elasticity of participants are assessed with myoton device for creating normative data

    1 year

Study Arms (2)

men

EXPERIMENTAL
Diagnostic Test: Myotonometric evaluation

women

EXPERIMENTAL
Diagnostic Test: Myotonometric evaluation

Interventions

Myotonometric evaluationDIAGNOSTIC_TEST

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.

menwomen

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu Üniversity

Gaziantep, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 28261109RESULT

  • 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

    RESULT

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 23, 2020

First Posted

February 28, 2020

Study Start

June 6, 2018

Primary Completion

January 12, 2019

Study Completion

February 20, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations

TU(1)