Robot Coach of Chronic Low Back Pain Patient

Study Overview
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Brief Summary
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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.

Official Title
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Preliminary Feasibility Study of Rehabilitation by Robot Coach of Chronic Low Back Pain Patient

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Device: Rehabilitation program with Poppy robot
* Other: Usual rehabilitation program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot Poppy group<br>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. | Device: Rehabilitation program with Poppy robot<br>* 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.<br>|
| Active Comparator: Control group<br>Usual 3hours daily (5 days a week) rehabilitation program without robot during 3 weeks | Other: Usual rehabilitation program<br>* Patient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 0 to Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| Number of adverse events |  | Day 0 to Day 90 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Low Back Pain, Rehabilitation, Robot Poppy