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

Study Overview

• Status: Recruiting
• Conditions: Spinal Disease
• Intervention / Treatment: Other: Kinematic sensors

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Nuno A.R. Cristino; Phone Number: +351217104400; Email: nuno.cristino.ext@nms.unl.pt

Study Locations

• Portugal
  • Lisbon, Portugal
    • Recruiting
    • Hospital da Luz Setúbal
    • Contact: Nuno Cristino; Phone Number: +351919484946

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Healthy volunteers	Other: Kinematic sensors; Comparative analysis of kinematic data acquired in supervised and unsupervised environment
Disease	Other: Kinematic sensors; Comparative analysis of kinematic data acquired in supervised and unsupervised environment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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).	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	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	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	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.	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.	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.	12 months

Collaborators and Investigators

• Sponsor: Universidade Nova de Lisboa

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases
• Other Study ID Numbers: a319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No