Trials / Recruiting
RecruitingNCT06129682
Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)
Self-rehabilitation At Home After LumbaR Arthrodesis
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Lumbar arthrodesis is more and more common in general population. Patients need early reeducation after surgery but do not always have access to a physiotherapist. The investigators aim to study the benefits of self-rehabilitation at home after lumbar arthrodesis, showing amelioration in lumbar pain and in quality of life for concerned patients. For this, the investigators designed a randomized-controlled study to test if self-rehabilitation at home right after surgery is superior than rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment for our patients).
Detailed description
Due to population aging, lumbar arthrodesis is becoming more frequent in general population. At the same time, those patients need early rehabilitation, even if they do not experiment any motor disability after surgery : it has been showed that early rehabilitation improves lumbar pain thanks to muscle strengthening. The design of the study is prospective,monocentric, controlled and randomized. This study compares progressive self-rehabilitation at home after lumbar arthrodesis, explained to the patient by a physiotherapist during his or her stay at the hospital and started right after surgery, versus rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment). The primary outcome is decrease of lumbar pain at 6 weeks and 3 months after surgery. The secondary outcomes are improvement of functional abilities and improvement of pelvis and limbs ranges of motion. Patients of both groups will be followed by surgeon and physiotherapist at 6 weeks and 3 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Self rehabilitation at home | 6 week program of exercise at home of gradual intensity and duration |
Timeline
- Start date
- 2023-12-18
- Primary completion
- 2028-10-01
- Completion
- 2028-10-01
- First posted
- 2023-11-13
- Last updated
- 2025-03-19
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT06129682. Inclusion in this directory is not an endorsement.