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

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

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).

Study Overview

• Status: Completed
• Conditions: Lower Back Pain
• Intervention / Treatment: Other: Routine Physical Therapy; Device: I-Moove Physical Therapy

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHRU de Montpellier - Hôpital Lapeyronie
  • Nîmes Cedex 9, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Arnaud Dupeyron, MD, PhD, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2014
• Primary Completion (Actual): June 28, 2018
• Study Completion (Actual): June 28, 2018

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: April 15, 2014
• First Posted (Estimate): April 16, 2014

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Proprioception
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Musculoskeletal Diseases
• Other Study ID Numbers: AOI/2012/AD-01; 2013-A00743-42 (Other Identifier: RCB number)