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Clinical Trials in France / NCT04075539
Recruiting Phase 3

Home-based Cycling for People With Lumbar Spinal Stenosis

NCT04075539 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Phase 3
Started
2025-02-10
Last updated
2025-11-20

Condition(s) studied

Symptomatic Lumbar Spinal Stenosis

Investigational drug(s) / intervention(s)

Home-based cycling programusual care

Home-based cycling program: Usual care (i.e. standardized prescription of 6 sessions of outpatient physiotherapy), and * 1 supervised session of cycling aimed at explaining how to use the connected ergometric bicycle and at designing a personalized home-based cycling program * a 12-month home-based cycling program using connected ergometric bicycles which intensity and dose are self-determined * 3 phone or email contacts with a care provider to deliver positive feedbacks and encouragements

usual care: A prescription of 6 sessions of outpatient physiotherapy

Study 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

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in back-specific activity limitations — 4 months after-randomization
    Mean change from baseline in mean back-specific activity limitations in the previous month using the self-administered Oswestry Disability Index (ODI) total score (0 no limitations and 100 maximal limitations).

Trial sites (1)

FacilityCityRegionStatus
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 Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04075539 on ClinicalTrials.gov ↗ ← All trials in France