Gait Analysis and Degenerative Spine
- Conditions
- Spinal Disease
- Interventions
- Other: Kinematic sensors
- Registration Number
- NCT06335095
- Lead Sponsor
- Universidade Nova de Lisboa
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Disease Kinematic sensors - Control Kinematic sensors Healthy volunteers
- Primary Outcome Measures
Name Time Method 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 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 - 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 - 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 - 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 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 Outcome Measures
Name Time Method 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 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 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 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 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 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 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 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 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 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 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
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).
Trial Locations
- Locations (1)
Hospital da Luz Setúbal
🇵🇹Lisbon, Portugal