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Recruiting Phase 3 NCT04075539

Home-based Cycling for People With Lumbar Spinal Stenosis

Trial Parameters

Condition Symptomatic Lumbar Spinal Stenosis
Sponsor Assistance Publique - Hôpitaux de Paris
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 302
Sex ALL
Min Age 50 Years
Max Age N/A
Start Date 2025-02-10
Completion 2027-06
Interventions
Home-based cycling programusual care

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 with usual care to usual care.

Eligibility Criteria

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

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