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

Study Overview
=================
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),

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

Conditions
-----------------
Lower Back Pain

Intervention / Treatment
-----------------
* Other: Routine Physical Therapy
* Device: I-Moove Physical Therapy


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine Physical Therapy<br>Patients randomized to this arm will follow a classic, routine, physical therapy program. Intervention: Routine Physical Therapy | Other: Routine Physical Therapy<br>* Patients randomized to this arm will participate in a classic physical therapy program (15 weeks, a total of 15 sessions).<br>|
| Experimental: I-Moove Physical Therapy<br>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<br>* Patients randomized to this arm will participate in a physical therapy program using the I-Moove device (15 weeks, a total of 15 sessions).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postural stability on the platform, eyes closed |  | Baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postural stability on the platform, eyes closed |  | Baseline to 6 months | 
| Change in postural stability on the platform, eyes open |  | Baseline to 6 weeks | 
| Change in postural stability on the platform, eyes open |  | Baseline to 6 months | 
| Change in postural stability on the platform, eyes open and with an unstable surface |  | Baseline to 6 weeks | 
| Change in postural stability on the platform, eyes open and with an unstable surface |  | Baseline to 6 months | 
| Change in postural stability on the platform, eyes closed and with an unstable surface |  | Baseline to 6 weeks | 
| Change in postural stability on the platform, eyes closed and with an unstable surface |  | Baseline to 6 months | 
| Abdominal endurance: Ito test |  | Baseline (day 0) | 
| Abdominal endurance: Ito test |  | 6 weeks | 
| Abdominal endurance: Ito test |  | 6 months | 
| Sorensen test |  | Baseline (day 0) | 
| Sorensen test |  | 6 weeks | 
| Sorensen test |  | 6 months | 
| Dallas questionnaire |  | Baseline (day 0) | 
| Dallas questionnaire |  | 6 weeks | 
| Dallas questionnaire |  | 6 months | 
| Quebec questionnaire |  | Baseline (day 0) | 
| Quebec questionnaire |  | 6 weeks | 
| Quebec questionnaire |  | 6 months | 
| FABQ questionnaire |  | Baseline (day 0) | 
| FABQ questionnaire |  | 6 weeks | 
| FABQ questionnaire |  | 6 months | 
| Tampa Score |  | Baseline (day 0) | 
| Tampa Score |  | 6 weeks | 
| Tampa Score |  | 6 months | 
| Visual analog scale for pain | ranging from 0 to 10 | Baseline (day 0) | 
| Visual analog scale for pain | ranging from 0 to 10 | 6 weeks | 
| Visual analog scale for pain | ranging from 0 to 10 | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Proprioception