Lumbar Spinal Stenosis Clinical Trial
— FLEXCAL PilotOfficial title:
Barriers and Facilitators to a Home-based Cycling Program Tailored to Patients' Preferences in Lumbar Spinal Stenosis Using Connected Ergometric Bicycles: a 3-month Open Pilot Study
Verified date | October 2017 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to determine whether a home-based cycling program for patients with lumbar spinal stenosis is a feasible and acceptable
Status | Completed |
Enrollment | 15 |
Est. completion date | December 21, 2016 |
Est. primary completion date | December 21, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Fulfilment of International Society for the Study of Lumbar Spine clinical diagnosis criteria for lumbar spinal stenosis with the presence of at least 6 out of the 7 following criteria: "pain in the buttocks or legs while walking"; "flex forward to relieve symptoms"; "feel relief when using a shopping cart or bicycle"; "motor or sensory disturbance while walking"; "normal and symmetric foot pulses"; "lower extremity weakness"; and "low back pain" - Lumbar spinal stenosis qualitatively detected on MRI or CT-scan Exclusion Criteria: - Inability to speak or read French - Impossibility or refusal to have an ergometric bicycle at home - Ongoing lumbar-flexion-based endurance training - History of spinal surgery - Cognitive impairment - Neurological or vascular disorder involving the lower limbs - Contraindication to cycling |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Cochin -Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Université Paris Descartes |
France,
Pauwels C, Roren A, Gautier A, Linières J, Rannou F, Poiraudeau S, Nguyen C. Barriers and facilitators to a home-based cycling program tailored to older patient preferences in lumbar spinal stenosis: a retrospective mixed-method study. Ann Phys Rehabil Me — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Barriers to home-based cycling | Assessed by a qualitative approach using semi-structured interviews | 3 months | |
Primary | Facilitators to home-based cycling | Assessed by a qualitative approach using semi-structured interviews | 3 months | |
Secondary | Barriers to home-based cycling | Assessed by a qualitative approach using semi-structured interviews | Baseline | |
Secondary | Facilitators to home-based cycling | Assessed by a qualitative approach using semi-structured interviews | Baseline | |
Secondary | Number of training sessions to assess adherence to home-based cycling | assessed by automatic monitoring on a USB stick connected to the bicycle | 3 months | |
Secondary | Covered distance to assess adherence to home-based cycling | assessed by automatic monitoring on a USB stick connected to the bicycle | 3 months | |
Secondary | Duration of training sessions to assess adherence to home-based cycling | Number of training sessions, distance, duration and power assessed by automatic monitoring on a USB stick connected to the bicycle | 3 months | |
Secondary | Developed power to assess adherence to home-based cycling | assessed by automatic monitoring on a USB stick connected to the bicycle | 3 months | |
Secondary | Burden of a home-based cycling | Assessed by the Exercise Therapy Burden Questionnaire (0=no burden, and 100=maximal burden) | 3 months | |
Secondary | Mean change from baseline in mean lumbar pain in the past 48 hrs | Assessed by an 11-point numeric rating scale (0=no pan, and 100=maximal pain) | 3 months | |
Secondary | Mean change from baseline in mean radicular pain in the past 48 hrs | Assessed by an 11-point numeric rating scale (0=no pain, and 100=maximal pain) | 3 months | |
Secondary | Mean change from baseline in mean disability in the past 48 hrs | Assessed by an 11-point numeric rating scale (0=no disability, and 100=maximal disability) | 3 months | |
Secondary | Mean change from baseline in mean spine-specific activity limitation | Assessed by the Oswestry Disability Index (0=no limitation, and 100=maximal limitation) | 3 months | |
Secondary | Mean change from baseline in mean maximum walking distance | Assessed by an adapted version of the self-paced walking test | 3 months |
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