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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Enrollment
31
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.
CHRU de Brest
Brest, France
Fondation ILDYS - Service de MPR de l'appareil locomoteur de PERHARIDY
Roscoff, France
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.
Time frame: Day 0 to Week 4
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
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