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CompletedNCT02116387IMOOVE ITUpdated Jul 5, 2019

Traditional Rehabilitation Versus Rehabilitation With the Imoove® Device for Spinal Musculoskeletal Disorders

An interventional study of Routine Physical Therapy and I-Moove Physical Therapy in Lower Back Pain, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 2 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The main objective of this study is to evaluate in patients with chronic low back pain (lasting for more than 3 months and not postoperative) the effect of an instrumental rehabilitation using the I-Moove ® device compared to a conventional physiotherapy rehabilitation for ambulatory postural stability (mean and standard deviation of excursions from the center of gravity) without visual control, 6 weeks after the start of the rehabilitation protocol. We focus on the relative variation between the values obtained on day 0 versus 6 weeks, via measures performed on a force platform. The results will be stratified into 3 age groups (18-39 years, 40-60 years and over 60 years).

Read the detailed description

The secondary objectives of this study are to evaluate and compare the two physical therapy techniques at 6 weeks and 6 months after the start of the rehabilitation protocol in terms of:

A - improving postural stability and visual control on an unstable surface (with and without visual control)

B - improving levels of abdominal strength (Ito test) and erector spinae (Sørensen test)

C - the impact of back pain on daily life using questionnaires (Dallas, Québec, FABQ and Tampa questionnaires/scores)

D - Improvement of pain (Visual Analog Scale),

02

Conditions studied

  • Lower Back Pain

Keywords

  • Proprioception
03

In context

Musculoskeletal Diseases

657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.

This study's enrollment of 60 is below the median of 73 across 438 interventional studies indexed under Musculoskeletal Diseases.

Browse Musculoskeletal Diseases studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 6 months of follow-up
  • Patients with pain in the lumbar spine (low back pain) for at least 3 months, not in connection with an operation

Exclusion criteria

Exclusion Criteria:

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient will have difficulties with follow-up (the patient is about to move, or isn't motivated)
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • The patient has already participated in a dynamic physical therapy program
  • The patient has a contraindication for a treatment used in this study
  • The patient has had surgery in the past year
  • The patient has a pathology that can interfere with the physical therapy regimen (heart failure, respiratory failure, major orthopedic problems)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Routine Physical Therapy

    Patients randomized to this arm will follow a classic, routine, physical therapy program. Intervention: Routine Physical Therapy

    Other: Routine Physical Therapy

  • Experimental
    I-Moove Physical Therapy

    Patients randomized to this arm will follow a physical therapy program using the I-Moove device. Intervention: I-Moove Physical Therapy

    Device: I-Moove Physical Therapy

Interventions

  • OtherRoutine Physical Therapy

    Patients randomized to this arm will participate in a classic physical therapy program (15 weeks, a total of 15 sessions).

  • DeviceI-Moove Physical Therapy

    Patients randomized to this arm will participate in a physical therapy program using the I-Moove device (15 weeks, a total of 15 sessions).

06

What researchers measure

Primary outcomes

  1. Change in postural stability on the platform, eyes closed

    Time frame: Baseline to 6 weeks

Secondary outcomes

  1. Change in postural stability on the platform, eyes closed

    Time frame: Baseline to 6 months

  2. Change in postural stability on the platform, eyes open

    Time frame: Baseline to 6 weeks

  3. Change in postural stability on the platform, eyes open

    Time frame: Baseline to 6 months

  4. Change in postural stability on the platform, eyes open and with an unstable surface

    Time frame: Baseline to 6 weeks

  5. Change in postural stability on the platform, eyes open and with an unstable surface

    Time frame: Baseline to 6 months

  6. Change in postural stability on the platform, eyes closed and with an unstable surface

    Time frame: Baseline to 6 weeks

  7. Change in postural stability on the platform, eyes closed and with an unstable surface

    Time frame: Baseline to 6 months

  8. Abdominal endurance: Ito test

    Time frame: Baseline (day 0)

  9. Abdominal endurance: Ito test

    Time frame: 6 weeks

  10. Abdominal endurance: Ito test

    Time frame: 6 months

  11. Sorensen test

    Time frame: Baseline (day 0)

  12. Sorensen test

    Time frame: 6 weeks

  13. Sorensen test

    Time frame: 6 months

  14. Dallas questionnaire

    Time frame: Baseline (day 0)

  15. Dallas questionnaire

    Time frame: 6 weeks

  16. Dallas questionnaire

    Time frame: 6 months

  17. Quebec questionnaire

    Time frame: Baseline (day 0)

  18. Quebec questionnaire

    Time frame: 6 weeks

  19. Quebec questionnaire

    Time frame: 6 months

  20. FABQ questionnaire

    Time frame: Baseline (day 0)

  21. FABQ questionnaire

    Time frame: 6 weeks

  22. FABQ questionnaire

    Time frame: 6 months

  23. Tampa Score

    Time frame: Baseline (day 0)

  24. Tampa Score

    Time frame: 6 weeks

  25. Tampa Score

    Time frame: 6 months

  26. Visual analog scale for pain

    ranging from 0 to 10

    Time frame: Baseline (day 0)

  27. Visual analog scale for pain

    ranging from 0 to 10

    Time frame: 6 weeks

  28. Visual analog scale for pain

    ranging from 0 to 10

    Time frame: 6 months

07

Study locations

2 sites
  • CHRU de Montpellier - Hôpital Lapeyronie
    Montpellier, 34295, France
  • CHRU de Nîmes - Hôpital Universitaire Carémeau
    Nîmes Cedex 9, 30029, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02116387
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Apr 16, 2014
Start date
Jul 4, 2014
Primary completion
Jun 28, 2018
Completion
Jun 28, 2018
Last update
Jul 5, 2019

Study contacts

Arnaud Dupeyron, MD, PhD
study director · Centre Hospitalier Universitaire de Nîmes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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