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Robot Coach of Chronic Low Back Pain Patient (RCOOL)

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rehabilitation program with Poppy robot
Usual rehabilitation program
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Chronic Low Back Pain focused on measuring Chronic Low Back Pain, Rehabilitation, Robot Poppy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHRU de Brest
  • Fondation ILDYS - Service de MPR de l'appareil locomoteur de PERHARIDY

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

"Robot Poppy" group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Visual Analog Scale (EVA) of lumbar pain
Roland-Morris questionnaire
Dallas questionnaire
Fear Avoidance and Belief Questionnaire (FABQ)
Number of adverse events
Acceptability questionnaire
Number of exercises done during rehabilitation supervised by robot Poppy (30 minutes each day for 4 weeks)

Full Information

First Posted
August 8, 2017
Last Updated
April 6, 2020
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT03260738
Brief Title
Robot Coach of Chronic Low Back Pain Patient
Acronym
RCOOL
Official Title
Preliminary Feasibility Study of Rehabilitation by Robot "Coach" of Chronic Low Back Pain Patient
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
October 26, 2018 (Actual)
Study Completion Date
April 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Chronic Low Back Pain, Rehabilitation, Robot Poppy

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"Robot Poppy" group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Usual 3hours daily (5 days a week) rehabilitation program without robot during 3 weeks
Intervention Type
Device
Intervention Name(s)
Rehabilitation program with Poppy robot
Intervention Description
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
Other
Intervention Name(s)
Usual rehabilitation program
Intervention Description
Patient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks.
Primary Outcome Measure Information:
Title
Average time of the daily physical activity
Description
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.
Time Frame
Day 0 to Week 4
Secondary Outcome Measure Information:
Title
Visual Analog Scale (EVA) of lumbar pain
Time Frame
Day 0, Week 4 and Month 6
Title
Roland-Morris questionnaire
Time Frame
Day 0, Week 4 and Month 6
Title
Dallas questionnaire
Time Frame
Day 0, Week 4 and Month 6
Title
Fear Avoidance and Belief Questionnaire (FABQ)
Time Frame
Day 0, Week 4 and Month 6
Title
Number of adverse events
Time Frame
Day 0 to Day 90
Title
Acceptability questionnaire
Time Frame
Week 4 and Month 6
Title
Number of exercises done during rehabilitation supervised by robot Poppy (30 minutes each day for 4 weeks)
Time Frame
Day 0 to Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Fondation ILDYS - Service de MPR de l'appareil locomoteur de PERHARIDY
City
Roscoff
ZIP/Postal Code
29680
Country
France

12. IPD Sharing Statement

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Robot Coach of Chronic Low Back Pain Patient

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