Robot Coach of Chronic Low Back Pain Patient

Chronic Low Back Pain Clinical Trial

— RCOOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03260738
• Other study ID #: 29BRC17.0084
• Status: Completed
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: April 2, 2019

Study information

• Verified date: April 2020
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 2, 2019
• Est. primary completion date: October 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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.

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

Locations

Country	Name	City	State
France	CHRU de Brest	Brest
France	Fondation ILDYS - Service de MPR de l'appareil locomoteur de PERHARIDY	Roscoff

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analog Scale (EVA) of lumbar pain		Day 0, Week 4 and Month 6
Secondary	Roland-Morris questionnaire		Day 0, Week 4 and Month 6
Secondary	Dallas questionnaire		Day 0, Week 4 and Month 6
Secondary	Fear Avoidance and Belief Questionnaire (FABQ)		Day 0, Week 4 and Month 6
Secondary	Number of adverse events		Day 0 to Day 90
Secondary	Acceptability questionnaire		Week 4 and Month 6
Secondary	Number of exercises done during rehabilitation supervised by robot Poppy (30 minutes each day for 4 weeks)		Day 0 to Week 4