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The goal of this observational study is to analyse the biomechanics of a degenerative spinal disease. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Healthy volunteers |
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| Disease |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kinematic sensors | Other | Comparative analysis of kinematic data acquired in supervised and unsupervised environment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | 12 months |
| Change from baseline in gait parameter - step width (m) - at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months |
| Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with confirmed diagnosis of the spinal disease in study and that meet the eligibility criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nuno A.R. Cristino | Contact | +351217104400 | nuno.cristino.ext@nms.unl.pt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital da Luz Setúbal | Recruiting | Lisbon | Portugal |
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| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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The change will be defined by a 10% decrease in step width (meters) at 3 months from baseline assessment.
| 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. | 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. | 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). |
| 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). | 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). | 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). | 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). | 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 | 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 | 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 | 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. | 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. | 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. | 12 months |