NCT06335095

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Apr 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Apr 2024Sep 2026

First Submitted

Initial submission to the registry

November 30, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

November 30, 2023

Last Update Submit

March 13, 2025

Conditions

Spinal Disease

Outcome Measures

Primary Outcomes (9)

  • 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

    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

Secondary Outcomes (12)

  • Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 3 months

    3 months

  • Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months

    6 months

  • Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 12 months

    12 months

  • Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 3 months

    3 months

  • Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 6 months

    6 months

  • +7 more secondary outcomes

Study Arms (2)

Control

Healthy volunteers

Other: Kinematic sensors

Disease

Other: Kinematic sensors

Interventions

Kinematic sensorsOTHER

Comparative analysis of kinematic data acquired in supervised and unsupervised environment

ControlDisease

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital da Luz Setúbal

Lisbon, Portugal

RECRUITING

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Central Study Contacts

Nuno A.R. Cristino

CONTACT

+351217104400nuno.cristino.ext@nms.unl.pt

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2023

First Posted

March 28, 2024

Study Start

April 1, 2024

Primary Completion

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations

PT(1)