Gait Spine Functional Evaluation Protocol

NCT06400680 | Active Not Recruiting

• 1 other identifier: 1053
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Spine Kinematics; Thoracic Spine; Lumbar Spine; Motion analysis

Outcome Measures

Primary Outcomes (3)

• Intra/Inter Operator Reliability

  In the intra and interoperator repeatability analysis the investigators considered the correlation coefficient for the average RoM (in the 5 trials) in corresponding sessions. In particular, the investigators referred to standard interpretation criteria: the ICC values 0.5 and 0.75 indicate moderate reliability, values between 0.75 and 0.9 indicate good reliability, and values greater than, 0.90 indicate excellent reliability. Intra and inter operator reliability will be calculated at the achievement of ten healthy subjects ( during the first year), and then at the achievement of ten scoliotic subjects (during the second year)

  Through study completion, an average of 3 year

• Root mean square error as measure of accuracy

  For the accuracy analysis, the comparison between the reference measures and the measure obtained with the optoelectronic system for every segment of the spine assessed through the root mean square error

  Year 1

• SUS questionnaire score for usability assessment

  About the usability assessment, the System Usability Scale (SUS) collected at the end of each acquisition and calculated the average score value. The SUS provides a reliable tool for measuring the usability. The SUS questionnaire consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree

  Through study completion, an average of 3 year

Study Arms (2)

Healthy subjects

EXPERIMENTAL

Subjects without spine disease

Device: Spine Kinematic Assessment with Optoelectronic system

Scoliotic subjects

EXPERIMENTAL

Subjects with a scoliosis diagnosis

Device: Spine Kinematic Assessment with Optoelectronic system

Interventions

Spine Kinematic Assessment with Optoelectronic system DEVICE

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.

Healthy subjects; Scoliotic subjects

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• no history of low back pain or spine related pathology

You may not qualify if:

• motor impairments during gait
• For scoliosis group:
• Diagnosis of idiopathic scoliosis
• Autonomous gait
• motor impairments during gait

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Location

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Giuseppe Andreoni

  IRCCS E. Medea - La Nostra Famiglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: May 6, 2024
• Study Start: May 18, 2023
• Primary Completion (Estimated): May 18, 2026
• Study Completion (Estimated): May 18, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-03

Locations

IT (1)