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Traditional Rehabilitation Versus Rehabilitation With the Imoove® Device for Spinal Musculoskeletal Disorders (IMOOVE IT)

Primary Purpose

Lower Back Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Routine Physical Therapy
I-Moove Physical Therapy
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Back Pain focused on measuring Proprioception

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHRU de Montpellier - Hôpital Lapeyronie
  • CHRU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Routine Physical Therapy

I-Moove Physical Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in postural stability on the platform, eyes closed

Secondary Outcome Measures

Change in postural stability on the platform, eyes closed
Change in postural stability on the platform, eyes open
Change in postural stability on the platform, eyes open
Change in postural stability on the platform, eyes open and with an unstable surface
Change in postural stability on the platform, eyes open and with an unstable surface
Change in postural stability on the platform, eyes closed and with an unstable surface
Change in postural stability on the platform, eyes closed and with an unstable surface
Abdominal endurance: Ito test
Abdominal endurance: Ito test
Abdominal endurance: Ito test
Sorensen test
Sorensen test
Sorensen test
Dallas questionnaire
Dallas questionnaire
Dallas questionnaire
Quebec questionnaire
Quebec questionnaire
Quebec questionnaire
FABQ questionnaire
FABQ questionnaire
FABQ questionnaire
Tampa Score
Tampa Score
Tampa Score
Visual analog scale for pain
ranging from 0 to 10
Visual analog scale for pain
ranging from 0 to 10
Visual analog scale for pain
ranging from 0 to 10

Full Information

First Posted
April 15, 2014
Last Updated
July 3, 2019
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT02116387
Brief Title
Traditional Rehabilitation Versus Rehabilitation With the Imoove® Device for Spinal Musculoskeletal Disorders
Acronym
IMOOVE IT
Official Title
Traditional Rehabilitation Versus Rehabilitation With the Imoove® Device for Spinal Musculoskeletal Disorders: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 4, 2014 (Actual)
Primary Completion Date
June 28, 2018 (Actual)
Study Completion Date
June 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
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),

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain
Keywords
Proprioception

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine Physical Therapy
Arm Type
Active Comparator
Arm Description
Patients randomized to this arm will follow a classic, routine, physical therapy program. Intervention: Routine Physical Therapy
Arm Title
I-Moove Physical Therapy
Arm Type
Experimental
Arm Description
Patients randomized to this arm will follow a physical therapy program using the I-Moove device. Intervention: I-Moove Physical Therapy
Intervention Type
Other
Intervention Name(s)
Routine Physical Therapy
Intervention Description
Patients randomized to this arm will participate in a classic physical therapy program (15 weeks, a total of 15 sessions).
Intervention Type
Device
Intervention Name(s)
I-Moove Physical Therapy
Intervention Description
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 Outcome Measure Information:
Title
Change in postural stability on the platform, eyes closed
Time Frame
Baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Change in postural stability on the platform, eyes closed
Time Frame
Baseline to 6 months
Title
Change in postural stability on the platform, eyes open
Time Frame
Baseline to 6 weeks
Title
Change in postural stability on the platform, eyes open
Time Frame
Baseline to 6 months
Title
Change in postural stability on the platform, eyes open and with an unstable surface
Time Frame
Baseline to 6 weeks
Title
Change in postural stability on the platform, eyes open and with an unstable surface
Time Frame
Baseline to 6 months
Title
Change in postural stability on the platform, eyes closed and with an unstable surface
Time Frame
Baseline to 6 weeks
Title
Change in postural stability on the platform, eyes closed and with an unstable surface
Time Frame
Baseline to 6 months
Title
Abdominal endurance: Ito test
Time Frame
Baseline (day 0)
Title
Abdominal endurance: Ito test
Time Frame
6 weeks
Title
Abdominal endurance: Ito test
Time Frame
6 months
Title
Sorensen test
Time Frame
Baseline (day 0)
Title
Sorensen test
Time Frame
6 weeks
Title
Sorensen test
Time Frame
6 months
Title
Dallas questionnaire
Time Frame
Baseline (day 0)
Title
Dallas questionnaire
Time Frame
6 weeks
Title
Dallas questionnaire
Time Frame
6 months
Title
Quebec questionnaire
Time Frame
Baseline (day 0)
Title
Quebec questionnaire
Time Frame
6 weeks
Title
Quebec questionnaire
Time Frame
6 months
Title
FABQ questionnaire
Time Frame
Baseline (day 0)
Title
FABQ questionnaire
Time Frame
6 weeks
Title
FABQ questionnaire
Time Frame
6 months
Title
Tampa Score
Time Frame
Baseline (day 0)
Title
Tampa Score
Time Frame
6 weeks
Title
Tampa Score
Time Frame
6 months
Title
Visual analog scale for pain
Description
ranging from 0 to 10
Time Frame
Baseline (day 0)
Title
Visual analog scale for pain
Description
ranging from 0 to 10
Time Frame
6 weeks
Title
Visual analog scale for pain
Description
ranging from 0 to 10
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Dupeyron, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Study Director
Facility Information:
Facility Name
CHRU de Montpellier - Hôpital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 9
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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

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