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The goal of this investigation is to evaluate the safety and efficacy of the LumbaCure® device in elderly people suffering from low back pain. The study is being carried out at several sites, in nursing homes, in order to reach the elderly patients most at risk of a sedentary lifestyle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Intervention arm | Experimental | LumbaCure robotic device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LumbaCure | Device | LumbaCure® is a device developed to induce specific mobilization of the lower back in patients requiring physical rehabilitation for orthopaedic disorders, particularly chronic low back pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Low back pain | Mean intensity of low back pain during the last week, assessed on a numerical pain rating scale from 0 to 10 | Change between baseline and Visit 3 (Day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Functional mobility | Change in the time taken to complete the time up and go (TUG) test. The TUG consists of measuring the time it takes a person to get up from a chair, walk 3 metres at their usual pace, turn around, return to the chair and sit down. Two attempts are made and the best time is recorded | Between baseline and visit 3 (day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the device | The number, intensity and severity of adverse events are reported before each LumbaCure session. | through study completion, one month |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASBL " Mère Joséphine " - MRS Saint Joseph Blegny | Blégny | Liège | 4670 | 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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| Functional mobility |
Change in the time taken to complete the time up and go (TUG) test. The TUG consists of measuring the time it takes a person to get up from a chair, walk 3 metres at their usual pace, turn around, return to the chair and sit down. Two attempts are made and the best time is recorded |
| Between baseline and visit 2 (Day 14) |
| Functional mobility | Change in the time taken to complete the time up and go (TUG) test. The TUG consists of measuring the time it takes a person to get up from a chair, walk 3 metres at their usual pace, turn around, return to the chair and sit down. Two attempts are made and the best time is recorded | Follow-up period : between the end of the investigation period and 1 month post-study (Day 56 - Visit 4) |
| Low back pain | Weekly changes from baseline in mean intensity of low back pain during the last week, assessed on a numerical pain rating scale from 0 to 10. | Between baseline and each week through study completion, one month. |
| Low back pain | Current back pain intensity before and after each session, assessed on a numerical pain rating scale from 0 to 10. | Before and after each session [12 measures, 3x/week during one month] |
| Low back pain | Changes in mean intensity of low back pain in the last week, assessed on a numerical rating scale from 0 to 10, during the follow-up period between the end of the investigation period and 1 month post-study. | Follow-up : Between end of the investigation period [Day 28] and 1 month post-study. |
| Overall satisfaction of the physiotherapist with the LumbaCure® intervention | A single satisfaction score will be reported at the end of the intervention period by the physiotherapist:
| End of intervention period [Day 28] |
| Overall patient satisfaction with the LumbaCure® intervention | A single satisfaction score will be calculated at the end of the intervention period based on a series of three questions :
| End of intervention period [Day 28] |
| Risk of falling | Change in the risk of falling between baseline and the end of the intervention period, visit 3 (day 28), assessed by the Tinetti test. This test is a comprehensive assessment of both balance and gait. It assesses the patient's ability to change position, maintain balance in different situations and walk. | Between baseline and the end of the investigation,visit 3 [Day 28] |
| Risk of falling | Changes in the risk of falling during the follow-up period assessed by the Tinetti test. This test is a comprehensive assessment of both balance and gait. It assesses the patient's ability to change position, maintain balance in different situations and walk. | Between the end of the investigation,visit 3 [Day 28] and one month follow-up |
| D013568 |
| Pathological Conditions, Signs and Symptoms |