Robot Coach of Chronic Low Back Pain Patient

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-23

Study Completion Date

2019-04-02

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.

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Detailed Description

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Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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"Robot Poppy" group

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.

Group Type EXPERIMENTAL

Rehabilitation program with Poppy robot

Intervention Type DEVICE

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.

Control group

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

Group Type ACTIVE_COMPARATOR

Usual rehabilitation program

Intervention Type OTHER

Patient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks.

Interventions

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Rehabilitation program with Poppy robot

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.

Intervention Type DEVICE

Usual rehabilitation program

Patient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No