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The study will include patients suffering from nonspecific mechanical low back pain for more than 6 weeks. Two groups will be compared. A Control group and an Experimental group with the exoskeleton JAPET.W
The study will include patients suffering from nonspecific mechanical low back pain for more than 6 weeks. The study will consist of two groups: a control group (Group CTRL) and an experimental group (Group EXP). Participants will be categorized into two categories: "workers," patients on temporary work leave due to low back pain, and "non-workers," patients unable to work due to this condition after exhausting all available therapeutic solutions.
Monitoring period (30 physiotherapy sessions): evaluations will be conducted at sessions 1, 15 and 30, on the two groups. Evaluation session 3 months after the end of the physiotherapy sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group CTRL | No Intervention | Participants will undergo 30 sessions of conventional physiotherapy | |
| Group EXP | Experimental | Participants will undergo 30 sessions of physiotherapy with the use of the Japet.W+ Exoskeleton |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of the Exoskeleton JAPET.W | Other | Phsysiotherapy sessions with the support of the Exoskeleton JAPET.W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the efficacy of the JAPET.W - measurement of pain | VAS scale for pain (o -no pain to 10 - pain as bad as it could possibly be) : rate of the patients who had at least -20 points/100 on the VAS for pain | Up to six months |
| Assessment of the efficacy of the JAPET.W - consumption of analgesic | Assessment of analgesic use in the two groups at the first and last session | Up to six months |
| Assessment of the efficacy of the JAPET.W - functional assessment | Mobility assessment with the french version of Oswestry Disablility Index. The scale goes from 0 - no pain to 5 - worse. | Up to six months |
| Assessment of the efficacy of the JAPET.W - Assessment of the kinesiophobia | Comparison of the difference in TAMPA scale. This scale goes to 1-strongly disagree to 4-strongly agree with the proposal | Up to six months |
| Assessment of the efficacy of the JAPET.W - Assessment in quality of life | Assessment in quality of life with EQ-5D-5L. The scale goes to 1-totally able to carry out the activity up to 5-totally unable to do so. | Up to six months |
| Assessment of the efficacy of the JAPET.W - Assessment of the Anxiety level | Assessment of the Anxiety level with Hospital Anxiety Depression Scale. This scale ranges from 0-no anxiety to 3-totally anxious. | Up to six months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the safety of the JAPET.W | Rate of patients who had at least one device related adverse event during the clinical investigation. | Up to six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Serge TROUSSEL, MD | Contact | 0032 71 10 | 3638 | Serge.TROUSSEL@ghdc.be |
| Name | Affiliation | Role |
|---|---|---|
| Serge TROUSSEL, MD | Grand Hôpital de Charleroi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grand Hôpital de Charleroi | Recruiting | Charleroi | Hainaut | 6060 | Belgium |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |