Clinical Trials Directory

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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

TypeNameDescription
OTHERSelf rehabilitation at home6 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.