NCT04654572

Brief Summary

The investigate of mechanical properties of muscles in burned patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

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
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

10 months

First QC Date

November 27, 2020

Last Update Submit

December 14, 2020

Conditions

Keywords

Burnmusclemyotonometerviscoelasticitystiffness

Outcome Measures

Primary Outcomes (3)

  • Stiffness

    Myotonometric measurement was used to determine for muscle stiffness. Device has a probe that creates constant pre-excitations and generates short-term, low-force mechanical stimulations over skin. The stimulations induce damped natural oscillations in the tissue and the myoton device records these oscillations with an accelerometer. Muscle tone, elasticity, and stiffness are calculated separately by the device.

    6 week

  • Elasticity

    Myotonometric measurement was used to determine for muscle elasticity. Device has a probe that creates constant pre-excitations and generates short-term, low-force mechanical stimulations over skin. The stimulations induce damped natural oscillations in the tissue and the myoton device records these oscillations with an accelerometer. Muscle tone, elasticity, and stiffness are calculated separately by the device.

    6 week

  • Tone

    Myotonometric measurement was used to determine for muscle tone. Device has a probe that creates constant pre-excitations and generates short-term, low-force mechanical stimulations over skin. The stimulations induce damped natural oscillations in the tissue and the myoton device records these oscillations with an accelerometer. Muscle tone, elasticity, and stiffness are calculated separately by the device.

    6 week

Study Arms (2)

burned group

EXPERIMENTAL

burned patients

Diagnostic Test: Myotonometric measurement

control group

EXPERIMENTAL

sedentary people

Diagnostic Test: Myotonometric measurement

Interventions

Myotonometric assessment can predict the muscle stiffness, tone and elasticity

burned groupcontrol group

Eligibility Criteria

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

You may qualify if:

  • burned patient
  • major burn over %20 TBSA

You may not qualify if:

  • Amputation
  • Dead
  • Systemic disease and abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan kalyoncu üniversity

Gaziantep, 27144, Turkey (Türkiye)

Location

Related Publications (3)

  • Gittings PM, Grisbrook TL, Edgar DW, Wood FM, Wand BM, O'Connell NE. Resistance training for rehabilitation after burn injury: A systematic literature review & meta-analysis. Burns. 2018 Jun;44(4):731-751. doi: 10.1016/j.burns.2017.08.009. Epub 2017 Oct 7.

    PMID: 29017743BACKGROUND
  • Porter C, Hardee JP, Herndon DN, Suman OE. The role of exercise in the rehabilitation of patients with severe burns. Exerc Sport Sci Rev. 2015 Jan;43(1):34-40. doi: 10.1249/JES.0000000000000029.

    PMID: 25390300BACKGROUND
  • Ianieri G, Saggini R, Marvulli R, Tondi G, Aprile A, Ranieri M, Benedetto G, Altini S, Lancioni GE, Goffredo L, Bellomo RG, Megna M, Megna G. New approach in the assessment of the tone, elasticity and the muscular resistance: nominal scales vs MYOTON. Int J Immunopathol Pharmacol. 2009 Jul-Sep;22(3 Suppl):21-4. doi: 10.1177/03946320090220S304. No abstract available.

    PMID: 19887038BACKGROUND

MeSH Terms

Conditions

BurnsMuscular Atrophy

Condition Hierarchy (Ancestors)

Wounds and InjuriesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant of professeur

Study Record Dates

First Submitted

November 27, 2020

First Posted

December 4, 2020

Study Start

June 6, 2018

Primary Completion

March 20, 2019

Study Completion

August 20, 2020

Last Updated

December 16, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

The data of myotonometric measurement and physical characteristics of participants will share

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
after publication and 10 years

Locations