Gait Spine Functional Evaluation Protocol

NCT ID: NCT06400680

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-18
• Study Completion Date: 2026-05-18

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.

Detailed Description

The spine is the central supporting structure of the body and for the torso in particular, allowing for flexibility and shock absorption, as well as routing and protecting the spinal cord and supporting the head and upper limbs for sensory and motor functions. In this perspective the evaluation of its movements in a global and segmental contribution is of paramount importance and cannot be separated by the other tasks. The locomotor function was the first one targeted by human motion analysis and still represent the main application in the rehabilitation. Optoelectronic systems are the gold standard technique for this assessment and specific protocols are available and applied. Traditional stereophotogrammetric models were used to assess the kinematics of pelvis, hip, knee, ankle, trunk (considered as a single rigid segment that does not provide information on kinematic changes within the spine). Indeed, it is relevant to understand the integrated and synergic motion of the spine and other body segment for a variety of applications, such as clinical diagnosis, endoprosthesis design, and the evaluation of treatment outcomes. Therefore, an accurate trunk motion analysis may be useful during medical diagnostic-therapeutic process. The aim of this study is introducing a new protocol consisting of a marker set, i.e. an innovative and integrated biomechanical model of the human body for the global analysis of spine and body movement during gait allows for a more detailed evaluation of the motor behavior and its abnormalities to better characterize the functionality of the spine at the level of its three main segments (upper thoracic, lower thoracic and lumbar), both on the sagittal, frontal and transversal plane, during walking. The development of a new protocol of analysis requires the validation before its definitive and clinical application. More in detail, the validation should be carried out in terms of both comparisons with reference absolute measures and the evaluation of its repeatability with healthy subjects.

Conditions

Spine Disease; Gait

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy subjects

Subjects without spine disease

Group Type: EXPERIMENTAL

Spine Kinematic Assessment with Optoelectronic system

Intervention Type: 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.

Scoliotic subjects

Subjects with a scoliosis diagnosis

Group Type: EXPERIMENTAL

Spine Kinematic Assessment with Optoelectronic system

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• no history of low back pain or spine related pathology

• Diagnosis of idiopathic scoliosis
• Autonomous gait

Exclusion Criteria

• motor impairments during gait

For scoliosis group:

• motor impairments during gait

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS Eugenio Medea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Andreoni

Role: PRINCIPAL_INVESTIGATOR

IRCCS E. Medea - La Nostra Famiglia

Locations

IRCCS E. Medea

Bosisio Parini, Lecco, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giuseppe Andreoni

Role: CONTACT

giuseppe.andreoni@lanostrafamiglia.it

031877350

Facility Contacts

Giuseppe Andreoni

Role: primary

giuseppe.andreoni@lanostrafamiglia.it

031877350

Other Identifiers

1053

Identifier Type: -

Identifier Source: org_study_id