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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "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. |
|
| Control group | Active Comparator | Usual 3hours daily (5 days a week) rehabilitation program without robot during 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Brest | Brest | 29200 | France | |||
| Fondation ILDYS - Service de MPR de l'appareil locomoteur de PERHARIDY |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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|
| Usual rehabilitation program | Other | Patient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks. |
|
| 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 |
| Acceptability questionnaire | Week 4 and Month 6 |
| Number of exercises done during rehabilitation supervised by robot Poppy (30 minutes each day for 4 weeks) | Day 0 to Week 4 |
| Roscoff |
| 29680 |
| France |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |