Robot Coach of Chronic Low Back Pain Patient
- Conditions
- Chronic Low Back Pain
- Interventions
- Other: Usual rehabilitation programDevice: Rehabilitation program with Poppy robot
- Registration Number
- NCT03260738
- Lead Sponsor
- University Hospital, Brest
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Usual rehabilitation program Usual 3hours daily (5 days a week) rehabilitation program without robot during 3 weeks "Robot Poppy" group Rehabilitation program with Poppy robot 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Visual Analog Scale (EVA) of lumbar pain 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 Roland-Morris questionnaire Day 0, 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 Acceptability questionnaire Week 4 and Month 6
Trial Locations
- Locations (2)
CHRU de Brest
🇫🇷Brest, France
Fondation ILDYS - Service de MPR de l'appareil locomoteur de PERHARIDY
🇫🇷Roscoff, France