Spinal DiseaseNCT06335095
Gait Analysis and Degenerative Spine
An observational study of Spinal Disease, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Disease
- What is being tested?
- Kinematic sensors
- How many people
- 200 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2024to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with confirmed diagnosis of the spinal disease in study and that meet the eligibility criteria.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Hospital da Luz Setúbal
Lisbon
Nuno Cristino, +351919484946
About this study
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
- Conditions
- Spinal Disease
- Being tested
- Kinematic sensors
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinematic sensorsOther
Comparative analysis of kinematic data acquired in supervised and unsupervised environment
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy volunteers Receives: Other: Kinematic sensors | |
| Disease | Not described Receives: Other: Kinematic sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (12)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Apr 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335095
- Sponsor's protocol ID
- a319
- Status last verified
- Mar 2025
- First submitted
- 30 Nov 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Analysis and Degenerative Spine
- ClinicalTrials.gov ID
- NCT06335095
- Acronym / sponsor ID
- a319
- Conditions
- Spinal Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Kinematic sensorsHealthy volunteers |
| Disease | – | Other: Kinematic sensors |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed diagnosis of the spinal disease in study and that meet the eligibility criteria.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinematic sensorsComparative analysis of kinematic data acquired in supervised and unsupervised environment | Other | Control, Disease |
Primary outcome
Change from baseline in gait parameter - speed (m/s) - at 3 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
The change will be defined by a 10% decrease in step width (meters) at 12 months from baseline assessment.
12 secondary outcomes
Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 3 months
Time frame: 3 months
Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months
Time frame: 6 months
Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 12 months
Time frame: 12 months
Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 3 months
Time frame: 3 months
Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 6 months
Time frame: 6 months
Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 12 months
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
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
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
Time frame: 12 months
Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 3 months
Time frame: 3 months
Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 6 months
Time frame: 6 months
Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Disease, run by Universidade Nova de Lisboa at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nuno A.R. Cristino (+351217104400, nuno.cristino.ext@nms.unl.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in gait parameter - speed (m/s) - at 3 months (time frame: 3 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.