NCT03260738

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 23, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2019

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

August 8, 2017

Last Update Submit

April 6, 2020

Conditions

Chronic Low Back Pain

Keywords

Chronic Low Back PainRehabilitationRobot Poppy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

"Robot Poppy" group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Other: Usual rehabilitation program

Interventions

Rehabilitation program with Poppy robotDEVICE

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.

"Robot Poppy" group
Usual rehabilitation programOTHER

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

Control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Low back pain (more than 6 months)
  • Patient who has completed an outpatient rehabilitation program with at least 20 spine-centric sessions
  • Adult between 18 and 70 years old
  • Patient affiliated to French social security system
  • Patient having signed an informed consent of participation for research

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Brest

Brest, 29200, France

Location

Fondation ILDYS - Service de MPR de l'appareil locomoteur de PERHARIDY

Roscoff, 29680, France

Location

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2017

First Posted

August 24, 2017

Study Start

October 23, 2017

Primary Completion

October 26, 2018

Study Completion

April 2, 2019

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations

FR(2)