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Gait Analysis and Degenerative Spine

ConditionSpinal Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-85
SponsorUniversidade Nova de Lisboa

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Previous spine surgery

Spinal instability

Neurological disease that might interfere with walking

Known orthopedic conditions that causes significant gait impairment

Trial population

Patients with confirmed diagnosis of the spinal disease in study and that meet the eligibility criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Kinematic sensors

    Other intervention

    Comparative analysis of kinematic data acquired in supervised and unsupervised environment

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Control1 intervention
Group B: Disease1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade Nova de Lisboa

Lead sponsor

Source ClinicalTrials.gov
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