Validity and Reliability of Trunk Strength Device

NCT06330129 | Completed DMC

• 1 other identifier: Pegasus01_Val
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Trunk Muscle Strength

Keywords

Trunk muscle strength; Isometric device; Pegasus; Validity; Reliability; Muscle Activation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• MRI muscle morphology

  0.5-1hour

• Electromyography (EMG) activity

  1hour

Study Arms (1)

Healthy subjects

EXPERIMENTAL

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

Interventions

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.

Healthy subjects

Eligibility Criteria

• Age: 18 Years - 59 Years
• Gender Eligibility Details: The study is open to both males and females (biologically); 15 for each group
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Schulthess Klinik: lead
• Balgrist Campus AG: collaborator

Study Sites (1)

Schulthess Klinik

Zurich, Canton of Zurich, 8008, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 26, 2024
• Study Start: November 15, 2024
• Primary Completion: March 31, 2025
• Study Completion: April 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2024-11

Locations

CH (1)