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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Lower Back Pain

Treatments: Device: I-Moove Physical Therapy; Other: Routine Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02116387

2013-A00743-42 (Other Identifier)

AOI/2012/AD-01

Details and patient eligibility

About

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).

Full 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),

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Routine Physical Therapy

Active Comparator group

Description:

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

Treatment:

Other: Routine Physical Therapy

I-Moove Physical Therapy

Experimental group

Description:

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

Treatment:

Device: I-Moove Physical Therapy