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Recruiting NCT06335095

Gait Analysis and Degenerative Spine

— Observational Spinal Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Kinematic sensors.
Who it may be relevant to
Registry conditions: Spinal Disease. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Other Kinematic sensors
    Comparative analysis of kinematic data acquired in supervised and unsupervised environment

Primary outcome measures

  • Change from baseline in gait parameter - speed (m/s) - at 3 months [Time frame: 3 months]
  • Change from baseline in gait parameter - speed (m/s) - at 6 months [Time frame: 6 months]
  • Change from baseline in gait parameter - speed (m/s) - at 12 months [Time frame: 12 months]
  • Change from baseline in gait parameter - step length (m) - at 3 months [Time frame: 3 months]
  • Change from baseline in gait parameter - step length (m) - at 6 months [Time frame: 6 months]
  • Change from baseline in gait parameter - step length (m) - at 12 months [Time frame: 12 months]
  • Change from baseline in gait parameter - step width (m) - at 3 months [Time frame: 3 months]
  • Change from baseline in gait parameter - step width (m) - at 6 months [Time frame: 6 months]
  • Change from baseline in gait parameter - step width (m) - at 12 months [Time frame: 12 months]
Secondary outcome measures (12)
  • Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 3 months [Time frame: 3 months]
  • Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months [Time frame: 6 months]
  • Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 12 months [Time frame: 12 months]
  • Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 3 months [Time frame: 3 months]
  • Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 6 months [Time frame: 6 months]
  • Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 12 months [Time frame: 12 months]
  • Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 3 months [Time frame: 3 months]
  • Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 6 months [Time frame: 6 months]
  • Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months [Time frame: 12 months]
  • Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 3 months [Time frame: 3 months]
  • Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 6 months [Time frame: 6 months]
  • Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 12 months [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Age between 50 and 85 years
  • Diagnosis of spinal disease by clinical and imagiological criteria
  • More than 3 months duration of disease
  • Ability to give consent
  • Fluent portuguese speaker

Exclusion criteria

  • Previous spine surgery
  • Spinal instability
  • Neurological disease that might interfere with walking
  • Known orthopedic conditions that causes significant gait impairment
  • Dementia or development disorder with cognitive impairment
  • Inability to give consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Portugal · 1 center
  • Hospital da Luz Setúbal — Lisbon

Identifiers

NCT: NCT06335095 · a319

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗