Robot Coach of Chronic Low Back Pain Patient (RCOOL)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Device: Rehabilitation program with Poppy robot; Other: Usual rehabilitation program

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • CHRU de Brest
  • Roscoff, France, 29680
    • Fondation ILDYS - Service de MPR de l'appareil locomoteur de PERHARIDY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "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.	Device: 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.
Active Comparator: Control group; Usual 3hours daily (5 days a week) rehabilitation program without robot during 3 weeks	Other: Usual rehabilitation program; Patient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Actual): October 26, 2018
• Study Completion (Actual): April 2, 2019

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; Chronic Low Back Pain; Robot Poppy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 29BRC17.0084

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No