Clinical trial NCT06400680: Gait Spine Functional Evaluation Protocol
Official title: Development of New Multifactorial Functional Evaluation Protocols and Related Indices for the Pediatric Age - Gait Spine Evaluation Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spine Disease
Gait
Keywords: Spine Kinematics
Thoracic Spine
Lumbar Spine
Motion analysis
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: For healthy group:

Inclusion Criteria:

* no history of low back pain or spine related pathology

Exclusion Criteria:

* motor impairments during gait

For scoliosis group:

Inclusion Criteria:

* Diagnosis of idiopathic scoliosis
* Autonomous gait

Exclusion Criteria:

* motor impairments during gait

Primary outcomes:
measure: Intra/Inter Operator Reliability
timeFrame: Through study completion, an average of 3 year
measure: Root mean square error as measure of accuracy
timeFrame: Year 1
measure: SUS questionnaire score for usability assessment
timeFrame: Through study completion, an average of 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS E. Medea
state: Lecco
Study officials:
affiliation: IRCCS E. Medea - La Nostra Famiglia
name: Giuseppe Andreoni
role: PRINCIPAL_INVESTIGATOR
References: