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Completed

NCT Number: NCT02116387

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

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Montpellier - Hôpital Lapeyronie, Montpellier, France

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About this study

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),

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

Routine physical therapy

Other

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

I-Moove Physical Therapy

Device

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

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

    Time frame: Baseline (day 0)

    ranging from 0 to 10

  27. Visual analog scale for pain

    Time frame: 6 weeks

    ranging from 0 to 10

  28. Visual analog scale for pain

    Time frame: 6 months

    ranging from 0 to 10

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Traditional Rehabilitation Versus Rehabilitation With the Imoove® Device for Spinal Musculoskeletal Disorders: a Randomised Controlled Trial

Acronym: IMOOVE IT

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 16, 2014
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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