An observational study in Spinal Disease, sponsored by Universidade Nova de Lisboa. Recruiting at 1 site in Portugal. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Universidade Nova de Lisboa · Observational
The goal of this observational study is to analyse the biomechanics of a degenerative spinal disease. The main questions it aims to answer are:
174 studies on the registry are indexed under Spinal Diseases; 39 are open to participants now.
This study's planned enrollment of 200 is above the median of 117 across 64 observational studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →Universidade Nova de Lisboa is the lead sponsor of 43 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with confirmed diagnosis of the spinal disease in study and that meet the eligibility criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Healthy volunteers
Other: Kinematic sensors
Other: Kinematic sensors
Comparative analysis of kinematic data acquired in supervised and unsupervised environment
Change from baseline in gait parameter - speed (m/s) - at 3 months
The change will be defined by a 10% increase in speed (meters/second) at 3 months from baseline assessment.
Time frame: 3 months
Change from baseline in gait parameter - speed (m/s) - at 6 months
The change will be defined by a 10% increase in speed (meters/second) at 6 months from baseline assessment.
Time frame: 6 months
Change from baseline in gait parameter - speed (m/s) - at 12 months
The change will be defined by a 10% increase in speed (meters/second) at 12 months from baseline assessment.
Time frame: 12 months
Change from baseline in gait parameter - step length (m) - at 3 months
The change will be defined by a 10% increase in step length (meters) at 3 months from baseline assessment.
Time frame: 3 months
Change from baseline in gait parameter - step length (m) - at 6 months
The change will be defined by a 10% increase in step length (meters) at 6 months from baseline assessment.
Time frame: 6 months
Change from baseline in gait parameter - step length (m) - at 12 months
The change will be defined by a 10% increase in step length (meters) at 12 months from baseline assessment.
Time frame: 12 months
Change from baseline in gait parameter - step width (m) - at 3 months
The change will be defined by a 10% decrease in step width (meters) at 3 months from baseline assessment.
Time frame: 3 months
Change from baseline in gait parameter - step width (m) - at 6 months
The change will be defined by a 10% decrease in step width (meters) at 6 months from baseline assessment.
Time frame: 6 months
Change from baseline in gait parameter - step width (m) - at 12 months
The change will be defined by a 10% decrease in step width (meters) at 12 months from baseline assessment.
Time frame: 12 months
Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 3 months
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points).
Time frame: 3 months
Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points).
Time frame: 6 months
Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 12 months
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points).
Time frame: 12 months
Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 3 months
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in ODI (range: 0-50 and higher scores are indicative of more disability).
Time frame: 3 months
Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 6 months
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in ODI (range: 0-50 and higher scores are indicative of more disability).
Time frame: 6 months
Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 12 months
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in ODI (range: 0-50 and higher scores are indicative of more disability).
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
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
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
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
In the core COMI-back, 1 question consists of 2 numerical rating scales to be answered from 0 to 10 and 5 questions to be answered by selecting 1 of 5 response options. The average of the 2 disability scores forms the disability dimension subscore. A total COMI score is determined by averaging the 5 dimension scores.
Time frame: 3 months
Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 6 months
In the core COMI-back, 1 question consists of 2 numerical rating scales to be answered from 0 to 10 and 5 questions to be answered by selecting 1 of 5 response options. The average of the 2 disability scores forms the disability dimension subscore. A total COMI score is determined by averaging the 5 dimension scores.
Time frame: 6 months
Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 12 months
In the core COMI-back, 1 question consists of 2 numerical rating scales to be answered from 0 to 10 and 5 questions to be answered by selecting 1 of 5 response options. The average of the 2 disability scores forms the disability dimension subscore. A total COMI score is determined by averaging the 5 dimension scores.
Time frame: 12 months
Plan to share: Undecided
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Universidade Nova de Lisboa