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Gait Spine Functional Evaluation Protocol

NCT06400680 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-14

No results posted yet for this study

Summary

The goal of this clinical trial is to develop and validate of a new protocol for multifactorial functional assessment of the kinematics of spinal and total body movements during walking by means of the optoelectronic motion analysis system in healthy and scoliosis subjects.

The main questions it aims to answer are:

* Is feasibility developing a protocol to assess the spine kinematic during walking?
* Is the intra and inter operator reliability of the developed protocol acceptable?
* Is the usability of the developed protocol acceptable? During data acquisition a trained therapist placed reflective markers on the skin of the participants in the selected body landmarks. The participants will be asked to perform five trial of walking barefoot on a 6 meters distance at a self-selected normal-pace speed, for each session.

Conditions

  • Spine Disease
  • Gait

Interventions

DEVICE

Spine Kinematic Assessment with Optoelectronic system

All measurements will be obtained using an optoelectronic multicamera system for human motion analysis (with eight high-resolution cameras with infrared light and a sampling frequency of 100 Hz. The experimental protocol require the positioning of markers (plastic spheres covered by reflecting film). Markers will be placed by clinical operators (physiotherapists with training in optoelectronic system for human motion analysis) after training and experience in recognition of the position of spinous and transversal processes, by manual identification. During the data acquisition protocol, the subject perform five trial of walking barefoot on a 6 m distance at a self-selected normal-pace speed. Every subject repeated this operations 2 times with 2 different operators.

Sponsors & Collaborators

  • IRCCS Eugenio Medea

    lead OTHER

Principal Investigators

  • Giuseppe Andreoni · IRCCS E. Medea - La Nostra Famiglia

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-18
Primary Completion
2026-05-18
Completion
2026-05-18

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06400680 on ClinicalTrials.gov