Robot Coach of Chronic Low Back Pain Patient (RCOOL)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Other: Usual rehabilitation program; Device: Rehabilitation program with Poppy robot

Study type: Interventional

Funder types: Other

Identifiers

NCT03260738

29BRC17.0084

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 2 patient groups

"Robot Poppy" group

Experimental group

Description:

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.

Treatment:

Device: Rehabilitation program with Poppy robot

Control group

Active Comparator group

Description:

Usual 3hours daily (5 days a week) rehabilitation program without robot during 3 weeks

Treatment:

Other: Usual rehabilitation program