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

NCT04191759 | Completed

• 1 other identifier: ISOSTIFF
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Tendon Injuries; Muscle Tightness

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Patient characteristics

  One evaluation only, at the first visit after inclusion

• Physical characteristics, popliteal angle

  One evaluation only, at the first visit after inclusion

• Physical characteristics, Calf Circumference

  One evaluationsonly, at the first visit after inclusion (T1)

• Physical characteristics, ROM

  One evaluation only, at the first visit after inclusion

• Physical characteristics, Fingertip-to-Floor (FTF) Test

  One evaluation only, at the first visit after inclusion

Study Arms (1)

Test-Retest reproducibility group

EXPERIMENTAL

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.

Diagnostic Test: Test-Retest reproducibility

Interventions

Test-Retest reproducibility DIAGNOSTIC_TEST

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.

Test-Retest reproducibility group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU Caen Normandie

Caen, 14000, France

Location

MeSH Terms

Conditions

Tendon Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One single group of 16 healthy volunteers

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: December 10, 2019
• Study Start: June 12, 2018
• Primary Completion: July 15, 2018
• Study Completion: November 10, 2018
• Last Updated: March 26, 2025

Record last verified: 2019-12

Locations

FR (1)