Chronic Low Back PainRCOOLNCT03260738
Robot Coach of Chronic Low Back Pain Patient
A study testing Rehabilitation program with Poppy robot and Usual rehabilitation program in people with Chronic Low Back Pain, run by University Hospital, Brest at 2 sites in France.
Trial summary
The objective of KERAAL technological project is to create a new intelligent robot which allows a humanoid robot to record then to show and to follow the progress of rehabilitation sessions proposed by a physiotherapist to a patient, the latter being able to practice without the physiotherapist. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Rehabilitation program with Poppy robot and Usual rehabilitation program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Oct 2017to 2 Apr 2019
- 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
- Chronic Low back pain (more than 6 months)
- Patient who has completed an outpatient rehabilitation program with at least 20 spine-centric sessions
- Inclusion in a low back pain rehabilitation program in an inpatient our outpatient unit.
- Adult between 18 and 70 years old
- Patient affiliated to French social security system
- Patient having signed an informed consent of participation for research
Who cannot join
- Symptomatic low back pain (identified medical etiology)
- Isolated sciatica, whatever the cause
- Cruralgia
- Chronic widespread pain
- Age lower than 18 and higher than 70
- Unfit of agreeing or refusing to participate in the study
- Unstable medical situation preventing the continuous realization of a program of at least 4 weeks
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Brest
Brest, 29200
Fondation ILDYS - Service de MPR de l'appareil locomoteur de PERHARIDY
Roscoff, 29680
About this study
Official title: Preliminary Feasibility Study of Rehabilitation by Robot "Coach" of Chronic Low Back Pain Patient
The objective of KERAAL technological project is to create a new intelligent robot which allows a humanoid robot to record then to show and to follow the progress of rehabilitation sessions proposed by a physiotherapist to a patient, the latter being able to practice without the physiotherapist. The final objective is to stimulate and increase the overseen time of rehabilitation. Poppy robot was chosen as it is able to realize all kind of movements notably movements of the spine with 5 degrees of freedom associated to the several levels of the spine. It will allow to address the population included in the protocol. RCOOL study tries to validate this prototype device as tool of rehabilitation.
The main objective is the feasibility of the supervision by a humanoid robot of a succession of rehabilitation exercises.
RCOOL study is a randomized clinical trial checked under single-blind condition to compare two rehabilitation strategies, one with exercises executed by the patients and supervised by Poppy and the other one with usual rehabilitation protocol.
- Conditions
- Chronic Low Back Pain
- Being tested
- Rehabilitation program with Poppy robot, Usual rehabilitation program
- Keywords
- Chronic Low Back Pain, Rehabilitation, Robot Poppy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation program with Poppy robotDevice
Patient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks. Among those 3 hours, patients receive 30 minutes of physical exercises dedicated to mobility of the spine supervised by robot Poppy.
Usual rehabilitation programOther
Patient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| "Robot Poppy" group | Experimental | 30 minutes of daily rehabilitation program (physical exercises dedicated to the mobility of the spine) supervised by Poppy robot during 3 weeks included in a 3hours daily (5 days a week) rehabilitation program. Receives: Device: Rehabilitation program with Poppy robot |
| Control group | Active comparator | Usual 3hours daily (5 days a week) rehabilitation program without robot during 3 weeks Receives: Other: Usual rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average time of the daily physical activity
Each therapist note the time of each physical activity session with the usually breaks. The time of kinesitherapy included the activity supervised by poppy will allow to evaluate the prototype device feasibility.
Measured: Day 0 to Week 4
Secondary outcomes (7)
Visual Analog Scale (EVA) of lumbar pain
Measured: Day 0, Week 4 and Month 6
Roland-Morris questionnaire
Measured: Day 0, Week 4 and Month 6
Dallas questionnaire
Measured: Day 0, Week 4 and Month 6
Fear Avoidance and Belief Questionnaire (FABQ)
Measured: Day 0, Week 4 and Month 6
Number of adverse events
Measured: Day 0 to Day 90
Acceptability questionnaire
Measured: Week 4 and Month 6
Number of exercises done during rehabilitation supervised by robot Poppy (30 minutes each day for 4 weeks)
Measured: Day 0 to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start23 Oct 2017
- Primary completion26 Oct 2018
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260738
- Sponsor's protocol ID
- 29BRC17.0084
- Acronym
- RCOOL
- Status last verified
- Apr 2020
- First submitted
- 8 Aug 2017
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Feasibility Study of Rehabilitation by Robot "Coach" of Chronic Low Back Pain Patient
- ClinicalTrials.gov ID
- NCT03260738
- Acronym / sponsor ID
- RCOOL / 29BRC17.0084
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic Low Back Pain, Rehabilitation, Robot Poppy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 24 Aug 2017 (actual)
- 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 objective of KERAAL technological project is to create a new intelligent robot which allows a humanoid robot to record then to show and to follow the progress of rehabilitation sessions proposed by a physiotherapist to a patient, the latter being able to practice without the physiotherapist. The final objective is to stimulate and increase the overseen time of rehabilitation. Poppy robot was chosen as it is able to realize all kind of movements notably movements of the spine with 5 degrees of freedom associated to the several levels of the spine. It will allow to address the population included in the protocol. RCOOL study tries to validate this prototype device as tool of rehabilitation.
The main objective is the feasibility of the supervision by a humanoid robot of a succession of rehabilitation exercises.
RCOOL study is a randomized clinical trial checked under single-blind condition to compare two rehabilitation strategies, one with exercises executed by the patients and supervised by Poppy and the other one with usual rehabilitation protocol.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Robot Poppy" group | Experimental | Device: Rehabilitation program with Poppy robot30 minutes of daily rehabilitation program (physical exercises dedicated to the mobility of the spine) supervised by Poppy robot during 3 weeks included in a 3hours daily (5 days a week) rehabilitation program. |
| Control group | Active comparator | Other: Usual rehabilitation programUsual 3hours daily (5 days a week) rehabilitation program without robot during 3 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic Low back pain (more than 6 months)
- Patient who has completed an outpatient rehabilitation program with at least 20 spine-centric sessions
- Inclusion in a low back pain rehabilitation program in an inpatient our outpatient unit.
- Adult between 18 and 70 years old
- Patient affiliated to French social security system
Key exclusion criteria (7 listed)
- Symptomatic low back pain (identified medical etiology)
- Isolated sciatica, whatever the cause
- Cruralgia
- Chronic widespread pain
- Age lower than 18 and higher than 70
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 |
|---|---|---|
| Rehabilitation program with Poppy robotPatient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks. Among those 3 hours, patients receive 30 minutes of physical exercises dedicated to mobility of the spine supervised by robot Poppy. | Device | "Robot Poppy" group |
| Usual rehabilitation programPatient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks. | Other | Control group |
Primary outcome
Average time of the daily physical activity
Time frame: Day 0 to Week 4
Each therapist note the time of each physical activity session with the usually breaks. The time of kinesitherapy included the activity supervised by poppy will allow to evaluate the prototype device feasibility.
7 secondary outcomes
Visual Analog Scale (EVA) of lumbar pain
Time frame: Day 0, Week 4 and Month 6
Roland-Morris questionnaire
Time frame: Day 0, Week 4 and Month 6
Dallas questionnaire
Time frame: Day 0, Week 4 and Month 6
Fear Avoidance and Belief Questionnaire (FABQ)
Time frame: Day 0, Week 4 and Month 6
Number of adverse events
Time frame: Day 0 to Day 90
Acceptability questionnaire
Time frame: Week 4 and Month 6
Number of exercises done during rehabilitation supervised by robot Poppy (30 minutes each day for 4 weeks)
Time frame: Day 0 to Week 4
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 7 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation program with Poppy robot and Usual rehabilitation program in people with Chronic Low Back Pain, run by University Hospital, Brest 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 6 inclusion and 7 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 7 Apr 2020. 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?
Average time of the daily physical activity (time frame: Day 0 to Week 4). 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 7 Apr 2020.