Assessment of the Evolution of Lumbar Spine Movement Fluidity Using Xsens Inertial Sensors in Subjects With Chronic Low Back Pain Before and After Rehabilitation (Xmouv)

March 11, 2026 updated by: University Hospital, Montpellier

Xmouv - Assessment of the Evolution of Lumbar Spine Movement Fluidity Using Xsens Inertial Sensors in Subjects With Chronic Low Back Pain Before and After Rehabilitation

Low back pain, defined as pain located between the thoracolumbar junction and the lower gluteal fold, becomes chronic in 8% of patients. As the leading cause of disability worldwide, it has major individual and medico-economic consequences.

Three-dimensional biomechanical analysis allows exploration of movement alterations related to low back pain. Although several parameters have already been studied (maximum joint range of motion (ROM), lumbopelvic rhythm, movement variability, gait), no consistent kinematic profile has emerged. Movement fluidity, assessed by the presence of jerks (brief movement disturbances), remains under-described despite its relevance in evaluating movement quality.

Invistigators hypothesize that lumbar spine movement fluidity during flexion improves after a rehabilitation program and correlates with clinical response.

This project stands out by exploring a rarely studied parameter (movement fluidity) and integrating it as a potential indicator for rehabilitation monitoring.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 65 years inclusive
  • BMI between 18-30 kg/m²
  • Chronic low back pain lasting more than three months
  • Rehabilitation care in the Physical Medicine and Rehabilitation Department of Montpellier University Hospital

Exclusion Criteria:

  • Sciatica episode within the last three months
  • Traumatic, tumoral, or infectious cause of low back pain
  • History of spinal, pelvic, or hip fracture
  • Inflammatory rheumatism
  • Lumbar arthrodesis
  • Severe scoliosis
  • Subject with a legal protection measure (guardianship, curatorship)
  • Subject under legal protection
  • Subject not affiliated to a social security system or not benefiting from such a system
  • Absence of informed written consent
  • Pregnant or breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Compare Movement Fluidity Before and After Rehabilitation
Evolution of Movement Fluidity Before and After Rehabilitation in patients with chronic low back pain
Device: X-sens sensor
kinematic movement measurement using 5 Xsens inertial sensors (Awinda) placed on the head, thoracic vertebrae (T8), lumbar vertebrae (L1, L4), and sacrum (S1), before and after the rehabilitation program (ten working days). Movement will be measured during standardized tasks including 3 lumbar spine flexions and 3 right and left lumbar rotations. Movements will be recorded by the sensors at a frequency of 100 Hz.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correlation between the evolution of trunk flexion movement fluidity and the evolution of disability before and after rehabilitation program
Time Frame: 2 weeks

Movement velocity will be measured during flexion using Xsens inertial measurement units (head, T8, L1, L4, S1). Velocity profiles will identify acceleration and deceleration phases. Movement fluidity will be quantified by a normalized jerk metric: the count of local minima and maxima on the angular velocity curve divided by flexion/extension duration (peaks/s). This normalization accounts for variations in movement speed between individuals and measurement sessions, providing a standardized measure of movement smoothness where lower values indicate more fluid motion.

Disability will be measured by the change in the score of Oswestry Disability Index (ODI) questionary between the first and last day of rehabilitation. The ODI questionary contains ten topics concerning intensity of pain and activities of daily life. Each question is scored on a scale of 0-5 where zero indicates the least amount of disability and 5 indicating most severe disability. The ODI scale range from 0 to 100
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in range of motion (ROM) between the first and last day of rehabilitation program
Time Frame: 2 weeks
The evolution of trunk range of motion (degree) between the first and last day of rehabilitation will be measured during flexion and rotation movement using Xsens inertial measurement units positioned on the head and at T8, L1, L4 and S1. ROM represents the maximal angular displacement reached by the trunk during the movement and allows identification of the contribution of different segments.
2 weeks
Changes in maximum angular velocity between the first and last day of rehabilitation program
Time Frame: 2 weeks
The evolution of maximum angular velocity (degrees per second) between the first and last day of rehabilitation will be measured during flexion and rotation movements using Xsens inertial measurement units positioned on the head and at T8, L1, L4, S1. Angular velocity reflects the peak speed at which the trunk segment rotates during motion. The movement velocity will be assessed both locally and globally.
2 weeks
Changes in lumbopelvic rhythm between the first and last day of rehabilitation program
Time Frame: 2 weeks
Changes in lombopelvic rhythm between the first and last day of rehabilitation will be assessed during the flexion using Xsens inertial measurement units positioned on the head and at T8, L1, L4, S1. lombopelvic rhythm represents the coordination and relative contribution of lumbar spine and pelvic motion during bending tasks.
2 weeks
Changes in functional disability between the first and last day of rehabilitation program
Time Frame: 2 weeks
The evolution of functional disability between the first and last day of rehabilitation program will be measured by the Oswestry Disability Index (ODI) questionary. This self-completed questionnaire contains ten topics concerning intensity of pain, and activities of daily life. Each topic category contains 6 statements describing a growing degree of relative severity to a particular activity. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 where zero indicates the least amount of disability and 5 indicating most severe disability. The ODI scale range from 0 to 100 where zero corresponds
2 weeks
Changes in pain between the first and last day of rehabilitation program
Time Frame: 2 weeks
The evolution of pain intensity between the first and last day of rehabilitation program will be measured by Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 represents no pain and 10 represents maximum pain.
2 weeks
Changes in psychological impact between the first and last day of rehabilitation program
Time Frame: 2 weeks
The evolution of psychological impact between the first and last day of rehabilitation program will be measured by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 7 items designed to evaluate depression and 7 for the anxiety. Each item is rated on a 4-point scale ranging, from 0 = no, not at all, to 3 = yes.
2 weeks
Changes in kinesiophobia between the first and last day of rehabilitation program
Time Frame: 2 weeks
The evolution of kinesiophobia between the first and last day of rehabilitation program will be measured by the Tampa Scale of Kinesiophobia (TSK) measuring the fear that pain may occur as a result of movement. The TSK is a questionnaire of 17 questions rated by a four-point ordinal scale, ranging, from 1 for strongly disagree, to 4 for strongly agree.
2 weeks
Changes in catastrophizing between the first and last day of rehabilitation program
Time Frame: 2 weeks
The evolution of catastrophizing between the first and last day of rehabilitation program will be measured by the Pains Catastrophizing Scale (PCS) assessing the extent of catastrophic thinking related to pain. The PCS consists of 13 items, each rated on a 5-point Likert scale (0 = not at all to 4 = all the time).
2 weeks
Changes in fears and beliefs regarding work and physical activity between the first and last day of rehabilitation program
Time Frame: 2 weeks
The evolution of beliefs related to fear and avoidance of pain between the first and last day of rehabilitation program will be measured by the Fear avoidance Belief Questionnaire (FABQ). The FABQ comprises 16 items. Patients are asked to rate each item on a scale ranging from 0 for 'strongly disagree' to 6 for 'strongly agree'. It consists of two sub-scores: FABQ Physical (FABQ-PA), comprising 5 items and assessing beliefs related to physical activity. FABQ Work (FABQ-W), comprising 11 items and assessing beliefs related to work.
2 weeks
Changes in Schober index between the first and last day of rehabilitation program
Time Frame: 2 weeks
The Schober index is a clinical assessment tool used to evaluate lumbar spine flexion and mobility. The test is performed with the subject standing upright. The examiner marks a point over the fifth lumbar vertebra (L5) and a second point 10 cm above the first. The subject is then asked to bend forward maximally, and the distance between the two marks is measured again. A normal mobility is characterized by an increase in the distance between the two markers of 4 to 7 cm.
2 weeks
Changes in fingertip-to-floor distance between the first and last day of rehabilitation program
Time Frame: 2 weeks
The distance between the tips of the fingers and the floor (in cm) is measured when the subject standing with knees straight, leans forward as far as possible in an attempt to touch the floor with their fingers.
2 weeks
Changes in heel-to-buttock distance between the first and last day of rehabilitation program
Time Frame: 2 weeks
The distance between the heel and the buttock (in cm) is measured when the subject lying in a prone position. The examiner performs passive flexion of the knee by bringing the heel closer to the buttock and measures the distance
2 weeks
Changes in popliteal angle between the first and last day of rehabilitation program
Time Frame: 2 weeks
The popliteal angle (in degree) is measured between the axis of the leg and the axis of the hip when the subject is lying supine and the examiner performs passive flexion of the hip to 90° followed by passive extension of the knee. The measurement is taken on both sides.
2 weeks
Changes in Sorensen test between the first and last day of rehabilitation program
Time Frame: 2 weeks

The Sorensen Test is a clinical assessment used to measure the isometric endurance of the trunk muscles. The subject lies prone on a table with the upper edge of the iliac crest aligned with the table edge, and the lower body secured with straps at the pelvis, knees, and ankles. With arms crossed over the chest, the subject maintains the upper body in a horizontal position unsupported.

The test duration is recorded (in seconds) until the subject can no longer hold the position.
2 weeks
Changes in Shirado test between the first and last day of rehabilitation program
Time Frame: 2 weeks
The Shirado Test is a clinical assessment used to measure the strength and endurance of the abdominal muscles. The subject lies in a supine position with hips and knees flexed at 90 degrees, and arms crossed over the chest. The position is timed (in seconds) and the subject is asked to hold it for as long as possible. The test ends when the subject is no longer able to maintain the position.
2 weeks
Changes in isometric endurance of trunk muscles between the first and last day of rehabilitation program
Time Frame: 2 weeks
The isometric endurance of trunk muscles is assessed by the ratio between the time taken in the Shirado test (in seconds) and the time taken in the Sorensen test (in seconds).
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Isabel TAVARES, MD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL25_0310
  • 2025-A02160-49 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Back Pain

Clinical Trials on X-sens sensor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings