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Low Back PainXmouvNCT07327554

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

A study testing X-sens sensor in people with Low Back Pain, run by University Hospital, Montpellier at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Low Back Pain
What is being tested?
X-sens sensor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteFrance
Study dates
23 Feb 2026to Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • University Hospital of Montpellier

    Montpellier

    Isabel TAVARES, MD, 0467338717 ext. 33, i-tavaresfigueiredo@chu-montpellier.fr

    Recruiting

Other trials in France

About this study

Official title: 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.

Read more

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.

Conditions
Low Back Pain
Being tested
X-sens sensor
Keywords
Low back pain, kinematic, jerk, instability catch, aberrant movement patterns
Medical subject headings
Low Back Pain, Fasciculation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • X-sens sensorDevice

    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.

Study groups in NCT07327554
Study groupRoleWhat they receive
Compare Movement Fluidity Before and After RehabilitationExperimentalEvolution of Movement Fluidity Before and After Rehabilitation in patients with chronic low back pain
Receives: Device: X-sens sensor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between the evolution of trunk flexion movement fluidity and the evolution of disability before and after rehabilitation program

    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

    Measured: 2 weeks

Secondary outcomes (16)
  1. Changes in range of motion (ROM) between the first and last day of rehabilitation program

    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.

    Measured: 2 weeks

  2. Changes in maximum angular velocity between the first and last day of rehabilitation program

    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.

    Measured: 2 weeks

  3. Changes in lumbopelvic rhythm between the first and last day of rehabilitation program

    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.

    Measured: 2 weeks

  4. Changes in functional disability between the first and last day of rehabilitation program

    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

    Measured: 2 weeks

  5. Changes in pain between the first and last day of rehabilitation program

    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.

    Measured: 2 weeks

  6. Changes in psychological impact between the first and last day of rehabilitation program

    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.

    Measured: 2 weeks

  7. Changes in kinesiophobia between the first and last day of rehabilitation program

    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.

    Measured: 2 weeks

  8. Changes in catastrophizing between the first and last day of rehabilitation program

    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).

    Measured: 2 weeks

  9. Changes in fears and beliefs regarding work and physical activity between the first and last day of rehabilitation program

    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.

    Measured: 2 weeks

  10. Changes in Schober index between the first and last day of rehabilitation program

    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.

    Measured: 2 weeks

  11. Changes in fingertip-to-floor distance between the first and last day of rehabilitation program

    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.

    Measured: 2 weeks

  12. Changes in heel-to-buttock distance between the first and last day of rehabilitation program

    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

    Measured: 2 weeks

  13. Changes in popliteal angle between the first and last day of rehabilitation program

    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.

    Measured: 2 weeks

  14. Changes in Sorensen test between the first and last day of rehabilitation program

    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.

    Measured: 2 weeks

  15. Changes in Shirado test between the first and last day of rehabilitation program

    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.

    Measured: 2 weeks

  16. Changes in isometric endurance of trunk muscles between the first and last day of rehabilitation program

    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).

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2026
  2. Study start23 Feb 2026
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07327554
Sponsor's protocol ID
RECHMPL25_0310
Other IDs
2025-A02160-49
Acronym
Xmouv
Status last verified
Jun 2026
First submitted
18 Dec 2025
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing X-sens sensor in people with Low Back Pain, run by University Hospital, Montpellier at 1 site in France.

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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. 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 France. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Isabel TAVARES, MD (0467338717 ext. 33, i-tavaresfigueiredo@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between the evolution of trunk flexion movement fluidity and the evolution of disability before and after rehabilitation program (time frame: 2 weeks). 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 12 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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