Traditional Rehabilitation Versus Rehabilitation With the... | NCT02116387

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

NCT02116387

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Jul 5, 2019Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Lower Back Pain

Interventions

Routine Physical Therapy
I-Moove Physical Therapy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-A00743-42	Other Identifier	RCB number

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 4, 2014Actual

Primary Completion Date

Jun 28, 2018Actual

Completion Date

Jun 28, 2018Actual

First Submitted Date

Apr 15, 2014

First Submission Date that Met QC Criteria

Apr 15, 2014

First Posted Date

Apr 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2019

Last Update Posted Date

Jul 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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),

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in postural stability on the platform, eyes closed		Baseline to 6 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arnaud Dupeyron, MD, PhD	Centre Hospitalier Universitaire de Nīmes	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Montpellier - Hôpital Lapeyronie		Montpellier		34295	France
CHRU de Nîmes - Hôpital Universitaire Carémeau

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms