Validity and Reliability of Trunk Strength Device

NCT ID: NCT06330129

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2025-04-01

Brief Summary

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.

Detailed Description

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.

Conditions

Trunk Muscle Strength

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy subjects

30 healthy subjects undergo trunk muscle strength assessement using the Pegasus device, with repeated measurements to evaluate repeatability and correlation with both surface electromyography (EMG) and MRI scans of trunk muscles.

Group Type: EXPERIMENTAL

CTT Pegasus

Intervention Type: 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.

Interventions

CTT Pegasus

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Balgrist Campus AG

UNKNOWN

Sponsor Role: collaborator

Schulthess Klinik

OTHER

Sponsor Role: lead

Responsible Party

Jacopo Vitale

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Schulthess Klinik

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

Pegasus01_Val

Identifier Type: -

Identifier Source: org_study_id