Clinical trial NCT03260738: Robot Coach of Chronic Low Back Pain Patient
Official title: Preliminary Feasibility Study of Rehabilitation by Robot "Coach" of Chronic Low Back Pain Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Chronic Low Back Pain
Rehabilitation
Robot Poppy
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average time of the daily physical activity
timeFrame: Day 0 to Week 4
Secondary outcomes:
measure: Visual Analog Scale (EVA) of lumbar pain
timeFrame: Day 0, Week 4 and Month 6
measure: Roland-Morris questionnaire
timeFrame: Day 0, Week 4 and Month 6
measure: Dallas questionnaire
timeFrame: Day 0, Week 4 and Month 6
measure: Fear Avoidance and Belief Questionnaire (FABQ)
timeFrame: Day 0, Week 4 and Month 6
measure: Number of adverse events
timeFrame: Day 0 to Day 90
measure: Acceptability questionnaire
timeFrame: Week 4 and Month 6
measure: Number of exercises done during rehabilitation supervised by robot Poppy (30 minutes each day for 4 weeks)
timeFrame: Day 0 to Week 4
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Roscoff
country: France
facility: Fondation ILDYS - Service de MPR de l'appareil locomoteur de PERHARIDY
Study officials:
References: