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

Centre Hospitalier Universitaire de Nīmes60 enrolled

Overview

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).

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),

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lower Back Pain

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Change in postural stability on the platform, eyes closed

Time frame: Baseline to 6 weeks

Secondary Outcomes

Change in postural stability on the platform, eyes closed

Time frame: Baseline to 6 months

Change in postural stability on the platform, eyes open

Time frame: Baseline to 6 weeks

Change in postural stability on the platform, eyes open

Time frame: Baseline to 6 months

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

Time frame: Baseline to 6 weeks

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

Time frame: Baseline to 6 months

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

Time frame: Baseline to 6 weeks

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

Time frame: Baseline to 6 months

Abdominal endurance: Ito test

Time frame: Baseline (day 0)

Abdominal endurance: Ito test

Time frame: 6 weeks

Abdominal endurance: Ito test

Time frame: 6 months

Sorensen test

Time frame: Baseline (day 0)

Sorensen test

Time frame: 6 weeks

Sorensen test

Time frame: 6 months

Dallas questionnaire

Time frame: Baseline (day 0)

Dallas questionnaire

Time frame: 6 weeks

Dallas questionnaire

Time frame: 6 months

Quebec questionnaire

Time frame: Baseline (day 0)

Quebec questionnaire

Time frame: 6 weeks

Quebec questionnaire

Time frame: 6 months

FABQ questionnaire

Time frame: Baseline (day 0)

FABQ questionnaire

Time frame: 6 weeks

FABQ questionnaire

Time frame: 6 months

Tampa Score

Time frame: Baseline (day 0)

Tampa Score

Time frame: 6 weeks

Tampa Score

Time frame: 6 months

Visual analog scale for pain

ranging from 0 to 10

Time frame: Baseline (day 0)

Visual analog scale for pain

ranging from 0 to 10

Time frame: 6 weeks

Visual analog scale for pain

ranging from 0 to 10

Time frame: 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes