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

NCT02116387 | Completed

• 2 other identifiers: AOI/2012/AD-012013-A00743-42
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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).

Conditions

Lower Back Pain

Keywords

Proprioception

Outcome Measures

Primary Outcomes (1)

• Change in postural stability on the platform, eyes closed

  Baseline to 6 weeks

Secondary Outcomes (28)

• 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

Study Arms (2)

Routine Physical Therapy

ACTIVE COMPARATOR

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

Other: Routine Physical Therapy

I-Moove Physical Therapy

EXPERIMENTAL

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

Interventions

Routine Physical Therapy OTHER

Patients randomized to this arm will participate in a classic physical therapy program (15 weeks, a total of 15 sessions).

Routine Physical Therapy

I-Moove Physical Therapy DEVICE

Patients randomized to this arm will participate in a physical therapy program using the I-Moove device (15 weeks, a total of 15 sessions).

I-Moove Physical Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnaud Dupeyron, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 16, 2014
• Study Start: July 4, 2014
• Primary Completion: June 28, 2018
• Study Completion: June 28, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-01

Locations

FR (2)