Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04191759
Other study ID # ISOSTIFF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 12, 2018
Est. completion date November 10, 2018

Study information

Verified date December 2019
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date November 10, 2018
Est. primary completion date July 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Test-Retest reproducibility
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.

Locations

Country Name City State
France CHU Caen Normandie Caen

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Caen INSERM U1075 COMETE, UNICAEN, Caen France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Primary 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 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 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 One evaluation only, at the first visit after inclusion
Secondary Physical characteristics, popliteal angle The popliteal angle tested on both legs. One evaluation only, at the first visit after inclusion
Secondary Physical characteristics, Calf Circumference The Calf Circumference (CC) tested on both legs. One evaluationsonly, at the first visit after inclusion (T1)
Secondary Physical characteristics, ROM The passive ankle range of motion (ROM) tested on both legs. One evaluation only, at the first visit after inclusion
Secondary Physical characteristics, Fingertip-to-Floor (FTF) Test The Fingertip-to-Floor (FTF) Test on both legs. One evaluation only, at the first visit after inclusion
See also
  Status Clinical Trial Phase
Completed NCT03307499 - NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery N/A
Recruiting NCT01014494 - Adaprev in Digital Flexor Tendon Repair N/A
Completed NCT05254470 - Real-World Experience of Patients Treated for Musculoskeletal Injuries With SAM in Routine Care
Recruiting NCT04110665 - Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery Phase 4
Completed NCT02805751 - Early Controlled Loading on Conservative Treated Achilles Tendon Ruptures N/A
Recruiting NCT04144946 - Identification of Early Changes in Patellar Tendinopathy Using Ultra-high Field Strength MRI
Completed NCT04177537 - Real-World Experience of Athletes Treated With SAM
Suspended NCT03362424 - Mesenchymal Stem Cells in Rotator Cuff Repair Phase 2
Completed NCT04677985 - Analgesic Induces Similar Upper and Lower Body Pain Pressure Threshold Increases N/A
Not yet recruiting NCT05285020 - Antigravity Treadmill With Alter G on the Postural Stability of Traumatic Lower Limb Injuries N/A
Completed NCT03850210 - The Manchester Short Splint in the Rehabilitation of Zone II Flexor Tendon Repairs N/A
Active, not recruiting NCT02725346 - ArthroPlanner: A Surgical Planning Solution for Acromioplasty N/A
Recruiting NCT03828916 - NuShield in Surgical Peroneal Tendon Repair N/A
Completed NCT01726855 - Prevention of Adhesions Following Flexor Tendon Injury Within Zone II With Vascularized Finger Dorsal Fascial Flap
Withdrawn NCT00198185 - Cascade PRFM Study: The Evaluation of Cascade Platelet-Rich Fibrin Matrix (PRFM) on Rotator Cuff Healing Phase 3
Completed NCT05527886 - Acute Effects of Dynamic Stretching, Plyometrics, and Loading on Achilles Tendon Properties and Performance Outcomes N/A
Completed NCT03401177 - Treatment of Early Phase Achilles Tendinopathy - the Effect of NSAIDs N/A
Completed NCT02231190 - GSK1278863 Effects on Eccentric Exercise-Induced Muscle Damage Phase 1
Completed NCT02014662 - A Methodology Study to Assess Muscle Damage After Eccentric Exercise Phase 1
Recruiting NCT03880149 - The Effects of Omega-3 Status and Supplementation on Tendon Structure in Competitive Athletes N/A