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

Lower Back Pain Clinical Trial

— IMOOVE IT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116387
• Other study ID #: AOI/2012/AD-01
• Secondary ID: 2013-A00743-42
• Status: Completed
• Phase: N/A
• Start date: July 4, 2014
• Est. completion date: June 28, 2018

Study information

• Verified date: January 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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),

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 28, 2018
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain
• Musculoskeletal Diseases

Intervention

Other:
• Routine Physical Therapy
Patients randomized to this arm will participate in a classic physical therapy program (15 weeks, a total of 15 sessions).

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).

Locations

Country	Name	City	State
France	CHRU de Montpellier - Hôpital Lapeyronie	Montpellier
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postural stability on the platform, eyes closed		Baseline to 6 weeks
Secondary	Change in postural stability on the platform, eyes closed		Baseline to 6 months
Secondary	Change in postural stability on the platform, eyes open		Baseline to 6 weeks
Secondary	Change in postural stability on the platform, eyes open		Baseline to 6 months
Secondary	Change in postural stability on the platform, eyes open and with an unstable surface		Baseline to 6 weeks
Secondary	Change in postural stability on the platform, eyes open and with an unstable surface		Baseline to 6 months
Secondary	Change in postural stability on the platform, eyes closed and with an unstable surface		Baseline to 6 weeks
Secondary	Change in postural stability on the platform, eyes closed and with an unstable surface		Baseline to 6 months
Secondary	Abdominal endurance: Ito test		Baseline (day 0)
Secondary	Abdominal endurance: Ito test		6 weeks
Secondary	Abdominal endurance: Ito test		6 months
Secondary	Sorensen test		Baseline (day 0)
Secondary	Sorensen test		6 weeks
Secondary	Sorensen test		6 months
Secondary	Dallas questionnaire		Baseline (day 0)
Secondary	Dallas questionnaire		6 weeks
Secondary	Dallas questionnaire		6 months
Secondary	Quebec questionnaire		Baseline (day 0)
Secondary	Quebec questionnaire		6 weeks
Secondary	Quebec questionnaire		6 months
Secondary	FABQ questionnaire		Baseline (day 0)
Secondary	FABQ questionnaire		6 weeks
Secondary	FABQ questionnaire		6 months
Secondary	Tampa Score		Baseline (day 0)
Secondary	Tampa Score		6 weeks
Secondary	Tampa Score		6 months
Secondary	Visual analog scale for pain	ranging from 0 to 10	Baseline (day 0)
Secondary	Visual analog scale for pain	ranging from 0 to 10	6 weeks
Secondary	Visual analog scale for pain	ranging from 0 to 10	6 months