Trunk Muscle StrengthPEGASUSNCT06330129
Validity and Reliability of Trunk Strength Device
A study testing CTT Pegasus in people with Trunk Muscle Strength, run by Schulthess Klinik at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Trunk Muscle Strength
- What is being tested?
- CTT Pegasus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Nov 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- both male and female subjects
- age between 18 and 59 years
- BMI < 30 kg/m2
- cognitively intact (self-reported)
- autonomous walking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- CTT Pegasus
- Keywords
- Trunk muscle strength, Isometric device, Pegasus, Validity, Reliability, Muscle Activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTT PegasusDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CTT Pegasus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (2)
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.
Measured: 0.5-1hour
Electromyography (EMG) activity
the root mean square EMG activity recorded during maximal and submaximal voluntary contractions of respective muscles.
Measured: 1hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start15 Nov 2024
- Primary completion31 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trunk Muscle StrengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Collaborators
- Balgrist Campus AG
- Responsible party
- Principal investigator, Jacopo Vitale, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330129
- Sponsor's protocol ID
- Pegasus01_Val
- Acronym
- PEGASUS
- Status last verified
- Nov 2024
- First submitted
- 4 Mar 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Trunk Muscle Strength Assessements With Isometric Dynamometry
- ClinicalTrials.gov ID
- NCT06330129
- Acronym / sponsor ID
- PEGASUS / Pegasus01_Val
- Conditions
- Trunk Muscle Strength
- Keywords
- Trunk muscle strength, Isometric device, Pegasus, Validity, Reliability, Muscle Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Collaborators
- Balgrist Campus AG
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Device: CTT Pegasus30 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- both male and female subjects
- age between 18 and 59 years
- BMI < 30 kg/m2
- cognitively intact (self-reported)
- autonomous walking
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTT PegasusThe 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. | Device | Healthy subjects |
Primary outcome
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.
2 secondary outcomes
MRI muscle morphology
Time frame: 0.5-1hour
Electromyography (EMG) activity
Time frame: 1hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTT Pegasus in people with Trunk Muscle Strength, run by Schulthess Klinik at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximal isometric trunk muscle strength (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025; AzTrials last refreshed its copy on 28 Oct 2026.