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

Not Applicable

Completed

• Conditions: Lower Back Pain
• Interventions: Device: I-Moove Physical Therapy; Other: Routine Physical Therapy

• Registration Number: NCT02116387
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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),

Study Timeline

• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-16
• Study Start: 2014-07-04
• Primary Completion: 2018-06-28
• Study Completion: 2018-06-28
• Status Verified: 2019-01
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in postural stability on the platform, eyes closed	Baseline to 6 weeks

Secondary Outcome Measures

Name	Time	Method
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 months
Change in postural stability on the platform, eyes open and with an unstable surface	Baseline to 6 months
Sorensen test	6 months
Visual analog scale for pain	6 months	ranging from 0 to 10
Change in postural stability on the platform, eyes closed and with an unstable surface	Baseline to 6 months
Abdominal endurance: Ito test	6 months
Dallas questionnaire	6 months
FABQ questionnaire	6 months
Tampa Score	6 months
Quebec questionnaire	6 months

Trial Locations

Locations (2)

CHRU de Montpellier - Hôpital Lapeyronie; 🇫🇷 Montpellier, France

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France