Home-based Cycling for People With Lumbar Spinal Stenosis (NCT04075539) | Clinical Trial Compass
RecruitingPhase 3
Home-based Cycling for People With Lumbar Spinal Stenosis
France302 participantsStarted 2025-02-10
Plain-language 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 with usual care to usual care.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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