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RecruitingPhase 3NCT04075539

Home-based Cycling for People With Lumbar Spinal Stenosis

Home-based Cycling Using Connected Ergometric Bicycles for People With Lumbar Spinal Stenosis: a Randomized Controlled Trial

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

302 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

Symptomatic Lumbar Spinal Stenosis

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

Min Age: 50 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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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Interventions

OTHERHome-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

OTHERusual care

A prescription of 6 sessions of outpatient physiotherapy

Locations(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

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NCT04075539