Spinal Disease
Conditions
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
Interventions
OTHERKinematic sensors
Comparative analysis of kinematic data acquired in supervised and unsupervised environment
Sponsors
Universidade Nova de Lisboa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in gait parameter - speed (m/s) - at 3 months | 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 - speed (m/s) - at 6 months | 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 | 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 length (m) - at 3 months | 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 6 months | 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 - step length (m) - at 12 months | 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 - step width (m) - at 3 months | 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 | 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 | 12 months | The change will be defined by a 10% decrease in step width (meters) at 12 months from baseline assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 3 months | 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. |
| 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 Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months |
| Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 12 months | 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. |
| Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 6 months | 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. |
| Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 3 months | 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). |
| Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months | 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). |
| Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 12 months | 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). |
| Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 3 months | 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). |
| Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 6 months | 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). |
| Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 12 months | 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). |
| 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 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 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 6 months |
Countries
Portugal
Contacts
Primary ContactNuno A.R. Cristino
Outcome results
None listed