Status:
RECRUITING
Home-based Cycling for People With Lumbar Spinal Stenosis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Symptomatic Lumbar Spinal Stenosis
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The main objective of the study is to compare the efficacy on back-specific activity limitations at 4 months after-randomisation of home-based cycling using connected ergometric bicycles associated wi...
Detailed Description
Lumbar spinal stenosis is a prevalent and disabling condition in elderly people. Lumbar spinal stenosis results in back and leg pain when standing and walking (radicular claudication), while symptoms ...
Eligibility Criteria
Inclusion
- age ≥ 50 year-old
- radicular claudication (i.e. walking-induced low back, buttock and/or leg pain, relieved in siting and/or lumbar flexion positions) diagnosed by a physician
- MRI or CT-scan findings consistent with LSS reported on a written radiology report provided by a board-certified radiologist or a resident in radiology
Exclusion
- inability to speak and/or read French language
- inability or refusal to perform ergometric bicycle at home
- patients already having an ergometric bicycle at home
- history of lumbar spine surgery in the previous 12 months
- cognitive disorders
- severe neurologic or vascular disorders involving the lower limbs
- contraindication to a rehabilitation program assessed by medical examination
- people under tutorship or curatorship
- protected adults
Key Trial Info
Start Date :
February 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT04075539
Start Date
February 10 2025
End Date
February 1 2028
Last Update
November 20 2025
Active Locations (1)
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1
Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
Paris, Île-de-France Region, France, 75014