protocolSection identificationModule nctId: NCT06335095, orgStudyIdInfo id: a319, briefTitle: Gait Analysis and Degenerative Spine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Universidade Nova de Lisboa, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to analyse the biomechanics of a degenerative spinal disease. The main questions it aims to answer are:* What are the biomechanical variables affected by the disease* How they evolve with disease progression and treatment, conditionsModule conditions: Spinal Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Kinematic sensors, outcomesModule primaryOutcomes measure: Change from baseline in gait parameter - speed (m/s) - at 3 months, primaryOutcomes measure: Change from baseline in gait parameter - speed (m/s) - at 6 months, primaryOutcomes measure: Change from baseline in gait parameter - speed (m/s) - at 12 months, primaryOutcomes measure: Change from baseline in gait parameter - step length (m) - at 3 months, primaryOutcomes measure: Change from baseline in gait parameter - step length (m) - at 6 months, primaryOutcomes measure: Change from baseline in gait parameter - step length (m) - at 12 months, primaryOutcomes measure: Change from baseline in gait parameter - step width (m) - at 3 months, primaryOutcomes measure: Change from baseline in gait parameter - step width (m) - at 6 months, primaryOutcomes measure: Change from baseline in gait parameter - step width (m) - at 12 months, secondaryOutcomes measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 3 months, secondaryOutcomes measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months, secondaryOutcomes measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 12 months, secondaryOutcomes measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 3 months, secondaryOutcomes measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 6 months, secondaryOutcomes measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 12 months, secondaryOutcomes measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 3 months, secondaryOutcomes measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 6 months, secondaryOutcomes measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months, secondaryOutcomes measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 3 months, secondaryOutcomes measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 6 months, secondaryOutcomes measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 12 months, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False