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Reliability of the Passive Properties of the Calf Muscles in Healthy Subjects Assessed Using Isokinetic Device (ISOSTIFF)

Primary Purpose

Tendon Injuries, Muscle Tightness

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Test-Retest reproducibility
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tendon Injuries

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient who signed the research information form
  • Patient affiliated to a social security system
  • An active patient, under 45 years of age, who participates in at least 4 hours of physical activity per week

Exclusion Criteria:

  • Individuals unable to perform an isokinetic muscle testing
  • Individuals with a current or recent lower limb injury with time loss from sport participation within the previous month.

Sites / Locations

  • CHU Caen Normandie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test-Retest reproducibility group

Arm Description

Protocol is the same for extended or flexed knee. The testing apparatus was set up as described in the constructor owner's manual and subjects were positioned in the supine lying position. The After a 5 min rest period, the participant's ankle is passively stretched through slow loading cycles from 15° of ankle flexion to 35° of ankle extension. Oral instruction is given to the participants to stay relaxed and avoid any muscle contraction and movement of the leg throughout the passive stretching. To familiarize, participant have 3 repetitions of passive ankle flexion-extension at 5°.s-1, and after 2min rest, data are collected from one repetitions at 5°.s-1 in passive mode. The measurements are also performed at an angular rate of 90°.s-1, according to the same protocol. Data for maximal voluntary isokinetic contraction are collected from 3 maximal repetitions at 60°.s-1 in concentric mode and participant are encouraged by constant verbal stimulation.

Outcomes

Primary Outcome Measures

Change from Baseline stiffness parameters at 15 days to assess the reproducibility of stiffness parameters
Change from Baseline stiffness parameters at 15 days, measurement of passive peak torque at 0 and 10° and slope of curve during the passive ankle flexion using an isokinetic device
Change from Baseline viscoelastic parameters at 15 days to assess the reproducibility of viscoelastic parameters
Change from Baseline viscoelasticity parameters at 15 days, measurement of hysterisis (AUC release/AUC storage) during the passive ankle flexion/extension using an isokinetic device

Secondary Outcome Measures

Patient characteristics
Personal characteristics recorded in the medical report as age, gender, type of sport and sport level of practice and previous lower limb injuries
Physical characteristics, popliteal angle
The popliteal angle tested on both legs.
Physical characteristics, Calf Circumference
The Calf Circumference (CC) tested on both legs.
Physical characteristics, ROM
The passive ankle range of motion (ROM) tested on both legs.
Physical characteristics, Fingertip-to-Floor (FTF) Test
The Fingertip-to-Floor (FTF) Test on both legs.

Full Information

First Posted
August 27, 2019
Last Updated
December 9, 2019
Sponsor
University Hospital, Caen
Collaborators
INSERM U1075 COMETE, UNICAEN, Caen France
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1. Study Identification

Unique Protocol Identification Number
NCT04191759
Brief Title
Reliability of the Passive Properties of the Calf Muscles in Healthy Subjects Assessed Using Isokinetic Device
Acronym
ISOSTIFF
Official Title
Reliability of the Passive Properties of the Calf Muscles in Healthy Subjects Assessed Using Isokinetic Device
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
July 15, 2018 (Actual)
Study Completion Date
November 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Caen
Collaborators
INSERM U1075 COMETE, UNICAEN, Caen France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators designed this study to determine the test-retest reliability of the viscoelastic passive properties of the calf muscles assessed using isokinetic device in flexed and extended knee position. The second objective is to determine the clinical viability of the parameters using the coefficient of repeatability and to investigate the individual characteristics associated with increased calf stiffness or altered viscoelasticity
Detailed Description
Recordings using an isokinetic dynamometer make it possible to quantify the resisting force during passive muscle stretch for a constant speed movement in dorsal flexion (flexion) and its release in plantar flexion (extension). The surface electromyography (EMG) makes it possible to measure voluntary contraction and the movement is considered passive if the corrected and normalized EMG signal, using root-mean-square (RMS), is less than 10% RMS during the Maximal Voluntary Muscle Contraction (MVMC). Stiffness is calculated from the slope of the rise of the curve during the passive dorsiflexion phase of the joint. The elastic potential energy can be measured and corresponds to the area under the curve during elongation. During the plantar flexion return phase, there is a hysteresis phenomenon resulting in behavior that differs from the curve. This difference between the two curves corresponds to the behavior related to viscoelastic relaxation. Viscoelasticity has a thixotropic behavior, i.e. it varies over time, for example, with heating. These parameters have been studied together or separately to evaluate the effect of age or stretching on the passive mechanical properties of the calf. However, the test-retest reliability of the viscoelastic passive properties of the calf muscles assessed using isokinetic device has not been demonstrated. The investigators designed this study to determine the test-retest reliability of the viscoelastic passive properties of the calf muscles assessed using isokinetic device in flexed and extended knee position. The second objective is to determine the clinical viability of the parameters using the coefficient of repeatability and to investigate the individual characteristics associated with increased calf stiffness or altered viscoelasticity Muscle tension is expressed by the peak torque (Nm), recorded at neutral position (PT0°) and 10° flexion (PT10°). Plantarflexor stiffness is determined as the slope of the torque-angle curve expressed as Nm·degree-1 during the linear region form 0-10° flexion (Slope0-10). A measure of elastic energy storage is calculated through the AUC of the torque-angle curve across the all range of motion. Hystérésis over time due to viscoelastic stress relaxation is calculated as the percent reduction in work absorption between the muscle stretching and releasing phases . The flexed-to-extended ratio is calculated as the ratio of flexed knee to extended knee and evaluated for PT0°, PT10° and Slope0-10 values , at 5 and 90°/sec

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendon Injuries, Muscle Tightness

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One single group of 16 healthy volunteers
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test-Retest reproducibility group
Arm Type
Experimental
Arm Description
Protocol is the same for extended or flexed knee. The testing apparatus was set up as described in the constructor owner's manual and subjects were positioned in the supine lying position. The After a 5 min rest period, the participant's ankle is passively stretched through slow loading cycles from 15° of ankle flexion to 35° of ankle extension. Oral instruction is given to the participants to stay relaxed and avoid any muscle contraction and movement of the leg throughout the passive stretching. To familiarize, participant have 3 repetitions of passive ankle flexion-extension at 5°.s-1, and after 2min rest, data are collected from one repetitions at 5°.s-1 in passive mode. The measurements are also performed at an angular rate of 90°.s-1, according to the same protocol. Data for maximal voluntary isokinetic contraction are collected from 3 maximal repetitions at 60°.s-1 in concentric mode and participant are encouraged by constant verbal stimulation.
Intervention Type
Diagnostic Test
Intervention Name(s)
Test-Retest reproducibility
Intervention Description
Protocol is the same for extended or flexed knee. The testing apparatus was set up as described in the constructor owner's manual and subjects were positioned in the supine lying position. The After a 5 min rest period, the participant's ankle is passively stretched through slow loading cycles from 15° of ankle flexion to 35° of ankle extension. Oral instruction is given to the participants to stay relaxed and avoid any muscle contraction and movement of the leg throughout the passive stretching. To familiarize, participant have 3 repetitions of passive ankle flexion-extension at 5°.s-1, and after 2min rest, data are collected from one repetitions at 5°.s-1 in passive mode. The measurements are also performed at an angular rate of 90°.s-1, according to the same protocol. Data for maximal voluntary isokinetic contraction are collected from 3 maximal repetitions at 60°.s-1 in concentric mode and participant are encouraged by constant verbal stimulation.
Primary Outcome Measure Information:
Title
Change from Baseline stiffness parameters at 15 days to assess the reproducibility of stiffness parameters
Description
Change from Baseline stiffness parameters at 15 days, measurement of passive peak torque at 0 and 10° and slope of curve during the passive ankle flexion using an isokinetic device
Time Frame
Two evaluations on both dominant and non dominant knees: one evaluation at the first visit, and a second evaluation at the second visit at 15 days after the first visit
Title
Change from Baseline viscoelastic parameters at 15 days to assess the reproducibility of viscoelastic parameters
Description
Change from Baseline viscoelasticity parameters at 15 days, measurement of hysterisis (AUC release/AUC storage) during the passive ankle flexion/extension using an isokinetic device
Time Frame
Two evaluations on both dominant and non dominant knees: one evaluation at the first visit, and a second evaluation at the second visit at 15 days after the first visit
Secondary Outcome Measure Information:
Title
Patient characteristics
Description
Personal characteristics recorded in the medical report as age, gender, type of sport and sport level of practice and previous lower limb injuries
Time Frame
One evaluation only, at the first visit after inclusion
Title
Physical characteristics, popliteal angle
Description
The popliteal angle tested on both legs.
Time Frame
One evaluation only, at the first visit after inclusion
Title
Physical characteristics, Calf Circumference
Description
The Calf Circumference (CC) tested on both legs.
Time Frame
One evaluationsonly, at the first visit after inclusion (T1)
Title
Physical characteristics, ROM
Description
The passive ankle range of motion (ROM) tested on both legs.
Time Frame
One evaluation only, at the first visit after inclusion
Title
Physical characteristics, Fingertip-to-Floor (FTF) Test
Description
The Fingertip-to-Floor (FTF) Test on both legs.
Time Frame
One evaluation only, at the first visit after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient who signed the research information form Patient affiliated to a social security system An active patient, under 45 years of age, who participates in at least 4 hours of physical activity per week Exclusion Criteria: Individuals unable to perform an isokinetic muscle testing Individuals with a current or recent lower limb injury with time loss from sport participation within the previous month.
Facility Information:
Facility Name
CHU Caen Normandie
City
Caen
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Reliability of the Passive Properties of the Calf Muscles in Healthy Subjects Assessed Using Isokinetic Device

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