Clinical trial NCT06335095: Gait Analysis and Degenerative Spine
Official title: Gait Analysis and Degenerative Spine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Disease
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed diagnosis of the spinal disease in study and that meet the eligibility criteria.

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


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

Primary outcomes:
measure: Change from baseline in gait parameter - speed (m/s) - at 3 months
timeFrame: 3 months
measure: Change from baseline in gait parameter - speed (m/s) - at 6 months
timeFrame: 6 months
measure: Change from baseline in gait parameter - speed (m/s) - at 12 months
timeFrame: 12 months
measure: Change from baseline in gait parameter - step length (m) - at 3 months
timeFrame: 3 months
measure: Change from baseline in gait parameter - step length (m) - at 6 months
timeFrame: 6 months
measure: Change from baseline in gait parameter - step length (m) - at 12 months
timeFrame: 12 months
measure: Change from baseline in gait parameter - step width (m) - at 3 months
timeFrame: 3 months
measure: Change from baseline in gait parameter - step width (m) - at 6 months
timeFrame: 6 months
measure: Change from baseline in gait parameter - step width (m) - at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 3 months
timeFrame: 3 months
measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months
timeFrame: 6 months
measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 12 months
timeFrame: 12 months
measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 3 months
timeFrame: 3 months
measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 6 months
timeFrame: 6 months
measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 12 months
timeFrame: 12 months
measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 3 months
timeFrame: 3 months
measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 6 months
timeFrame: 6 months
measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months
timeFrame: 12 months
measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 3 months
timeFrame: 3 months
measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 6 months
timeFrame: 6 months
measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Hospital da Luz Setúbal
Study officials:
References: