Validity and Reliability of Trunk Strength Device (PEGASUS)

Validity and Reliability of Trunk Muscle Strength Assessements With Isometric Dynamometry

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Trunk Muscle Strength
• Intervention / Treatment: Device: CTT Pegasus

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jana Frangi, MSc; Phone Number: +41443857048; Email: jana.frangi@kws.ch
• Study Contact Backup: Name: Jacopo Vitale, Dr.; Phone Number: +41443857148; Email: jacopo.vitale@kws.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximal isometric trunk muscle strength	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.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI muscle morphology	the anatomical crosssectional area (CSA) of trunk muscles (multifidus, erector spinae, rectus abdominis, and obliquus externus abdominis) evaluated through an abdominal MRI.	0.5-1hour
Electromyography (EMG) activity	the root mean square EMG activity recorded during maximal and submaximal voluntary contractions of respective muscles.	1hour

Collaborators and Investigators

• Sponsor: Schulthess Klinik
• Collaborators: Balgrist Campus AG

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Validity; Reliability; Muscle Activation; Trunk muscle strength; Isometric device; Pegasus
• Other Study ID Numbers: Pegasus01_Val

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No