Robot Coach of Chronic Low Back Pain Patient

Overview

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.

Full Title of Study: “Preliminary Feasibility Study of Rehabilitation by Robot “Coach” of Chronic Low Back Pain Patient”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Device Feasibility
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 26, 2018

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: Control group
    • Usual 3hours daily (5 days a week) rehabilitation program without robot during 3 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Average time of the daily physical activity
    • Time Frame: Day 0 to Week 4
    • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Brest
  • Provider of Information About this Clinical Study
    • Sponsor

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