Gait Analysis and Degenerative Spine
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Spinal Disease
- Sponsor
- Universidade Nova de Lisboa
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change from baseline in gait parameter - step length (m) - at 3 months
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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
Investigators
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
Outcomes
Primary Outcomes
Change from baseline in gait parameter - step length (m) - at 3 months
Time Frame: 3 months
The change will be defined by a 10% increase in step length (meters) at 3 months from baseline assessment.
Change from baseline in gait parameter - step length (m) - at 12 months
Time Frame: 12 months
The change will be defined by a 10% increase in step length (meters) at 12 months from baseline assessment.
Change from baseline in gait parameter - speed (m/s) - at 3 months
Time Frame: 3 months
The change will be defined by a 10% increase in speed (meters/second) at 3 months from baseline assessment.
Change from baseline in gait parameter - step length (m) - at 6 months
Time Frame: 6 months
The change will be defined by a 10% increase in step length (meters) at 6 months from baseline assessment.
Change from baseline in gait parameter - speed (m/s) - at 6 months
Time Frame: 6 months
The change will be defined by a 10% increase in speed (meters/second) at 6 months from baseline assessment.
Change from baseline in gait parameter - speed (m/s) - at 12 months
Time Frame: 12 months
The change will be defined by a 10% increase in speed (meters/second) at 12 months from baseline assessment.
Change from baseline in gait parameter - step width (m) - at 3 months
Time Frame: 3 months
The change will be defined by a 10% decrease in step width (meters) at 3 months from baseline assessment.
Change from baseline in gait parameter - step width (m) - at 6 months
Time Frame: 6 months
The change will be defined by a 10% decrease in step width (meters) at 6 months from baseline assessment.
Change from baseline in gait parameter - step width (m) - at 12 months
Time Frame: 12 months
The change will be defined by a 10% decrease in step width (meters) at 12 months from baseline assessment.
Secondary Outcomes
- Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months(6 months)
- Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 6 months(6 months)
- Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 6 months(6 months)
- Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 3 months(3 months)
- Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 12 months(12 months)
- Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 3 months(3 months)
- Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 12 months(12 months)
- Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months(12 months)
- Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 3 months(3 months)
- Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 12 months(12 months)
- Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 6 months(6 months)
- Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 3 months(3 months)