Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400680
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-03-19
Brief Title:
Gait Spine Functional Evaluation Protocol
Sponsor:
IRCCS Eugenio Medea
Organization:
IRCCS Eugenio Medea
Study Overview
Official Title:
Development of New Multifactorial Functional Evaluation Protocols and Related Indices for the Pediatric Age - Gait Spine Evaluation Protocol
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None