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OpenTrials
Completed

NCT Number: NCT03260738

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Brest, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehabilitation program with Poppy robot

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.

Usual rehabilitation program

Other

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

Primary outcomes

  1. 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 outcomes

  1. Visual Analog Scale (EVA) of lumbar pain

    Time frame: Day 0, Week 4 and Month 6

  2. Roland-Morris questionnaire

    Time frame: Day 0, Week 4 and Month 6

  3. Dallas questionnaire

    Time frame: Day 0, Week 4 and Month 6

  4. Fear Avoidance and Belief Questionnaire (FABQ)

    Time frame: Day 0, Week 4 and Month 6

  5. Number of adverse events

    Time frame: Day 0 to Day 90

  6. Acceptability questionnaire

    Time frame: Week 4 and Month 6

  7. Number of exercises done during rehabilitation supervised by robot Poppy (30 minutes each day for 4 weeks)

    Time frame: Day 0 to Week 4

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: RCOOL

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 24, 2017
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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