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NCT Number: NCT06335095

Gait Analysis and Degenerative Spine

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

Recruiting

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Key information

Conditions

Spinal Disease Bone Diseases Musculoskeletal Diseases Spinal Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital da Luz Setúbal

Lisbon, Portugal

Location status: Recruiting

Location contact

Nuno Cristino

CONTACT

+351919484946

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Kinematic sensors

Other

Comparative analysis of kinematic data acquired in supervised and unsupervised environment

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

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

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: 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. Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 12 months

    Time frame: 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).

  7. 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 3 months

  8. 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 6 months

  9. 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 Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months

  10. Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 3 months

    Time frame: 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.

  11. Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 6 months

    Time frame: 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.

  12. Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 12 months

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nuno A.R. Cristino

CONTACT

[email protected]

+351217104400

Sponsors and collaborators

Lead sponsor

Universidade Nova de Lisboa

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 28, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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