Chronic Low Back Pain
Conditions
Keywords
Chronic Low Back Pain, Rehabilitation, Robot Poppy
Brief 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. 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.
Interventions
DEVICERehabilitation program with Poppy robot
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.
Patient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks.
Sponsors
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average time of the daily physical activity | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analog Scale (EVA) of lumbar pain | Day 0, Week 4 and Month 6 |
| Roland-Morris questionnaire | Day 0, Week 4 and Month 6 |
| Dallas questionnaire | Day 0, Week 4 and Month 6 |
| Fear Avoidance and Belief Questionnaire (FABQ) | Day 0, Week 4 and Month 6 |
| Acceptability questionnaire | Week 4 and Month 6 |
| Number of exercises done during rehabilitation supervised by robot Poppy (30 minutes each day for 4 weeks) | Day 0 to Week 4 |
| Number of adverse events | Day 0 to Day 90 |
Countries
France
Outcome results
None listed