NCT06975202

Brief Summary

The aim of the study is to investigate test-retest reliability and agreement of trunk muscle activation during functional tasks and clinical sensorimotor control tests in pain-free persons.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2024

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

1.5 years

First QC Date

September 20, 2024

Last Update Submit

May 7, 2025

Conditions

Keywords

reliabilityagreementmuscle activationfunctional tasks

Outcome Measures

Primary Outcomes (2)

  • Trunk muscle onset during the rapid arm movement test

    Trunk muscle onset latencies in response to the unilateral rapid arm movement test will be measured by means of electromyography.

    Baseline (test-session)

  • Trunk muscle onset during the rapid arm movement test

    Trunk muscle onset latencies in response to the unilateral rapid arm movement test will be measured by means of electromyography.

    After a 30-minute break (retest-session)

Secondary Outcomes (8)

  • Trunk muscle (co-)activation

    Baseline (test-session)

  • Trunk muscle (co-)activation

    After a 30-minute break (retest-session)

  • Back muscle activation

    Baseline (test-session)

  • Back muscle activation

    After a 30-minute break (retest-session)

  • Voluntary multifidus activation

    Baseline (test-session)

  • +3 more secondary outcomes

Study Arms (1)

Pain-free persons

Pain-free persons

Other: No intervention

Interventions

No intervention

Pain-free persons

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pain-free persons will be recruited through online advertisement, flyers and posters.

You may qualify if:

  • \- Pain-free persons between 18 and 65 years old

You may not qualify if:

  • Persons experiencing low back pain in the past year
  • Patients with serious underlying conditions (e.g., multiple sclerosis)
  • Previous spinal surgery
  • Persons with any type of blood clotting disorder
  • Persons with upper-limb complaints that prevent them from exerting (maximum) force with their arms or hands.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine and Health Sciences

Ghent, 9000, Belgium

RECRUITING

Related Publications (8)

  • Moseley GL, Hodges PW, Gandevia SC. External perturbation of the trunk in standing humans differentially activates components of the medial back muscles. J Physiol. 2003 Mar 1;547(Pt 2):581-7. doi: 10.1113/jphysiol.2002.024950. Epub 2002 Dec 20.

    PMID: 12562944BACKGROUND
  • MacDonald D, Moseley GL, Hodges PW. People with recurrent low back pain respond differently to trunk loading despite remission from symptoms. Spine (Phila Pa 1976). 2010 Apr 1;35(7):818-24. doi: 10.1097/BRS.0b013e3181bc98f1.

    PMID: 20228708BACKGROUND
  • Schelin L, Pini A, Markstrom JL, Hager CK. Test-retest reliability of entire time-series data from hip, knee and ankle kinematics and kinetics during one-leg hops for distance: Analyses using integrated pointwise indices. J Biomech. 2021 Jul 19;124:110546. doi: 10.1016/j.jbiomech.2021.110546. Epub 2021 Jun 12.

    PMID: 34171677BACKGROUND
  • Pini A, Markstrom JL, Schelin L. Test-retest reliability measures for curve data: an overview with recommendations and supplementary code. Sports Biomech. 2022 Feb;21(2):179-200. doi: 10.1080/14763141.2019.1655089. Epub 2019 Oct 3.

    PMID: 31578129BACKGROUND
  • Wildenbeest MH, Kiers H, Tuijt M, van Dieen JH. Reliability of measures to characterize lumbar movement patterns, in repeated seated reaching, in a mixed group of participants with and without low-back pain: A test-retest, within- and between session. J Biomech. 2021 May 24;121:110435. doi: 10.1016/j.jbiomech.2021.110435. Epub 2021 Apr 15.

    PMID: 33894470BACKGROUND
  • Matheve T, Hodges P, Danneels L. The Role of Back Muscle Dysfunctions in Chronic Low Back Pain: State-of-the-Art and Clinical Implications. J Clin Med. 2023 Aug 24;12(17):5510. doi: 10.3390/jcm12175510.

    PMID: 37685576BACKGROUND
  • Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827.

    PMID: 31151377BACKGROUND
  • Hebert JJ, Koppenhaver SL, Teyhen DS, Walker BF, Fritz JM. The evaluation of lumbar multifidus muscle function via palpation: reliability and validity of a new clinical test. Spine J. 2015 Jun 1;15(6):1196-202. doi: 10.1016/j.spinee.2013.08.056. Epub 2013 Oct 4.

    PMID: 24314767BACKGROUND

Study Officials

  • Lieven Danneels, Professor

    University Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lieven Danneels, Professor

CONTACT

Thomas Matheve, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2024

First Posted

May 16, 2025

Study Start

April 2, 2024

Primary Completion

October 15, 2025

Study Completion

October 15, 2025

Last Updated

May 16, 2025

Record last verified: 2025-05

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