Lower Back PainIMOOVE ITNCT02116387
Traditional Rehabilitation Versus Rehabilitation With the Imoove® Device for Spinal Musculoskeletal Disorders
A study testing Routine Physical Therapy and I-Moove Physical Therapy in people with Lower Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- Routine Physical Therapy and I-Moove Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Jul 2014to 28 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
Official title: 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).
Read the 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),
- Conditions
- Lower Back Pain
- Being tested
- Routine Physical Therapy, I-Moove Physical Therapy
- Keywords
- Proprioception
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Physical TherapyOther
Patients randomized to this arm will participate in a classic physical therapy program (15 weeks, a total of 15 sessions).
I-Moove Physical TherapyDevice
Patients randomized to this arm will participate in a physical therapy program using the I-Moove device (15 weeks, a total of 15 sessions).
| Study group | Role | What they receive |
|---|---|---|
| Routine Physical Therapy | Active comparator | Patients randomized to this arm will follow a classic, routine, physical therapy program.
Intervention: Routine Physical Therapy Receives: 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 Receives: Device: I-Moove Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postural stability on the platform, eyes closed
Measured: Baseline to 6 weeks
Secondary outcomes (28)
Change in postural stability on the platform, eyes closed
Measured: Baseline to 6 months
Change in postural stability on the platform, eyes open
Measured: Baseline to 6 weeks
Change in postural stability on the platform, eyes open
Measured: Baseline to 6 months
Change in postural stability on the platform, eyes open and with an unstable surface
Measured: Baseline to 6 weeks
Change in postural stability on the platform, eyes open and with an unstable surface
Measured: Baseline to 6 months
Change in postural stability on the platform, eyes closed and with an unstable surface
Measured: Baseline to 6 weeks
Change in postural stability on the platform, eyes closed and with an unstable surface
Measured: Baseline to 6 months
Abdominal endurance: Ito test
Measured: Baseline (day 0)
Abdominal endurance: Ito test
Measured: 6 weeks
Abdominal endurance: Ito test
Measured: 6 months
Sorensen test
Measured: Baseline (day 0)
Sorensen test
Measured: 6 weeks
Sorensen test
Measured: 6 months
Dallas questionnaire
Measured: Baseline (day 0)
Dallas questionnaire
Measured: 6 weeks
Dallas questionnaire
Measured: 6 months
Quebec questionnaire
Measured: Baseline (day 0)
Quebec questionnaire
Measured: 6 weeks
Quebec questionnaire
Measured: 6 months
FABQ questionnaire
Measured: Baseline (day 0)
FABQ questionnaire
Measured: 6 weeks
FABQ questionnaire
Measured: 6 months
Tampa Score
Measured: Baseline (day 0)
Tampa Score
Measured: 6 weeks
Tampa Score
Measured: 6 months
Visual analog scale for pain
ranging from 0 to 10
Measured: Baseline (day 0)
Visual analog scale for pain
ranging from 0 to 10
Measured: 6 weeks
Visual analog scale for pain
ranging from 0 to 10
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study start4 Jul 2014
- Primary completion28 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Dupeyron, MD, PhD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116387
- Sponsor's protocol ID
- AOI/2012/AD-01
- Other IDs
- 2013-A00743-42
- Acronym
- IMOOVE IT
- Status last verified
- Jan 2019
- First submitted
- 15 Apr 2014
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Rehabilitation Versus Rehabilitation With the Imoove® Device for Spinal Musculoskeletal Disorders: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02116387
- Acronym / sponsor ID
- IMOOVE IT / AOI/2012/AD-01
- Conditions
- Lower Back Pain
- Keywords
- Proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 4 Jul 2014 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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),
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Physical Therapy | Active comparator | Other: Routine Physical TherapyPatients randomized to this arm will follow a classic, routine, physical therapy program. Intervention: Routine Physical Therapy |
| I-Moove Physical Therapy | Experimental | Device: I-Moove Physical TherapyPatients randomized to this arm will follow a physical therapy program using the I-Moove device. Intervention: I-Moove Physical Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Physical TherapyPatients randomized to this arm will participate in a classic physical therapy program (15 weeks, a total of 15 sessions). | Other | Routine Physical Therapy |
| I-Moove Physical TherapyPatients randomized to this arm will participate in a physical therapy program using the I-Moove device (15 weeks, a total of 15 sessions). | Device | I-Moove Physical Therapy |
Primary outcome
Change in postural stability on the platform, eyes closed
Time frame: Baseline to 6 weeks
28 secondary outcomes
Change in postural stability on the platform, eyes closed
Time frame: Baseline to 6 months
Change in postural stability on the platform, eyes open
Time frame: Baseline to 6 weeks
Change in postural stability on the platform, eyes open
Time frame: Baseline to 6 months
Change in postural stability on the platform, eyes open and with an unstable surface
Time frame: Baseline to 6 weeks
Change in postural stability on the platform, eyes open and with an unstable surface
Time frame: Baseline to 6 months
Change in postural stability on the platform, eyes closed and with an unstable surface
Time frame: Baseline to 6 weeks
Change in postural stability on the platform, eyes closed and with an unstable surface
Time frame: Baseline to 6 months
Abdominal endurance: Ito test
Time frame: Baseline (day 0)
Abdominal endurance: Ito test
Time frame: 6 weeks
Abdominal endurance: Ito test
Time frame: 6 months
Sorensen test
Time frame: Baseline (day 0)
Sorensen test
Time frame: 6 weeks
Sorensen test
Time frame: 6 months
Dallas questionnaire
Time frame: Baseline (day 0)
Dallas questionnaire
Time frame: 6 weeks
Dallas questionnaire
Time frame: 6 months
Quebec questionnaire
Time frame: Baseline (day 0)
Quebec questionnaire
Time frame: 6 weeks
Quebec questionnaire
Time frame: 6 months
FABQ questionnaire
Time frame: Baseline (day 0)
FABQ questionnaire
Time frame: 6 weeks
FABQ questionnaire
Time frame: 6 months
Tampa Score
Time frame: Baseline (day 0)
Tampa Score
Time frame: 6 weeks
Tampa Score
Time frame: 6 months
Visual analog scale for pain
Time frame: Baseline (day 0)
Visual analog scale for pain
Time frame: 6 weeks
Visual analog scale for pain
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud Dupeyron, MD, PhD study director
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Physical Therapy and I-Moove Physical Therapy in people with Lower Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postural stability on the platform, eyes closed (time frame: Baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.