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Completed

NCT Number: NCT06330129

Validity and Reliability of Trunk Strength Device

The study aims to evaluate the accuracy and consistency of assessing trunk muscle strength using an isometric device (Pegasus, Leipzig, Germany). Thirty healthy volunteers will undergo maximal isometric strength testing with the device, repeated one week later to assess repeatability. Surface electrodes will measure muscle activation, while MRI scans will assess structural condition.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schulthess Klinik

Zurich, Canton of Zurich, 8008, Switzerland

About this study

The aim of the study is to assess the validity and repeatability of trunk muscle strength evaluation using an isometric device (Pegasus, Leipzig, Germany) and to investigate it. Thirty healthy volunteer participants will undergo testing of maximal isometric (non-moving) strength using this device. The same strength measurement procedure will be repeated one week later for all participants to determine if the measurements are repeatable, i.e., if the device is capable of providing similar strength data in two closely timed measurements. To assess whether the device actually provides reliable strength data for the trunk muscles, surface electrodes will be additionally placed on the involved muscles to understand the extent of neural activation of these muscles during the test. Additionally, an MRI examination will be conducted for all study participants to assess the structural condition of the trunk muscles.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • both male and female subjects
  • age between 18 and 59 years
  • BMI < 30 kg/m2
  • cognitively intact (self-reported)
  • autonomous walking

Exclusion criteria

  • age under 18 years or over 60 years
  • any prior spinal surgery or other musculoskeletal surgery having an impact on movement
  • acute or chronic back pain in the last 6 months(self-reported)
  • pregnancy (self-reported)
  • inability to perform the planned set of activities included in the study (e.g. maximal voluntary contraction torque test)
  • inability to give consent

Treatment and study plan

CTT Pegasus

Device

The intervention aims to assess the construct validity of trunk flexor, extensor, and rotator muscle strength using the CTT PEGASUS isometric dynamometer (Leipzig, Germany). This involves correlating muscle strength measured isometrically with its physiological determinants: MRI-based anatomical cross-sectional area (CSA) in the lumbar region and muscle activation measured via surface electromyography (EMG) of spine and trunk muscles. Additionally, the intervention will assess the test-retest reliability of isometric strength of trunk flexors, extensors, and rotators.

Primary outcomes

  1. maximal isometric trunk muscle strength

    Time frame: 1 hour

    The computer-assisted test and trainig device (CTT) PEGASUS provides data on back muscle strength in isometric conditions, which constitutes the main endpoint of the present project.

Secondary outcomes

  1. MRI muscle morphology

    Time frame: 0.5-1hour

    the anatomical crosssectional area (CSA) of trunk muscles (multifidus, erector spinae, rectus abdominis, and obliquus externus abdominis) evaluated through an abdominal MRI.

  2. Electromyography (EMG) activity

    Time frame: 1hour

    the root mean square EMG activity recorded during maximal and submaximal voluntary contractions of respective muscles.

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Collaborators

  • Balgrist Campus AG

Registry information

Official study title

Validity and Reliability of Trunk Muscle Strength Assessements With Isometric Dynamometry

Acronym: PEGASUS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2024
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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