Functional Assessment Protocol for the Upper Limb for Pediatric Age

NCT ID: NCT06400667

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

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 for each upper limb of a determinate functional task for each session.

Detailed Description

Acquired brain injuries (ABIs)and cerebral palsy (CP) can lead to a wide range of impairments, including weakness or paralysis on one side of the body known as hemiplegia. In hemiplegic patients, the rehabilitation of the upper limb skills is crucial, because the recovery has an immediate impact on patient quality of life. Therefore, an accurate upper limb motion analysis may be useful during medical diagnostic-therapeutic process, it is relevant to understand the integrated and synergic motion of the upper limbs for a variety of applications, such as clinical diagnosis, endoprosthesis design, and the evaluation of treatment outcomes. There are many clinical scales used to assess the upper extremity. Most of these use an ordinal-level scoring system, with scores assigned to the patient by the observing physician or therapist. Another way to assess upper limb activity is through kinematics data from 3D motion capture. Kinematics data provide an objective and quantifiable method, as well as allowing the use of several otherwise undetectable metrics: time, velocity, and joint angles. 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 upper limb during functional tasks allows for a more detailed evaluation of the motor behavior and its abnormalities to better characterize the functionality of the upper, both on the sagittal, frontal and transversal plane. 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

Upper Extremity; Child; Range of Motion, Articular

Study Design

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

Study Groups

Healthy subjects

Subjects without upper limb disease

Group Type: EXPERIMENTAL

Upper limb 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 60 Hz. The experimental protocol require the positioning of markers (plastic spheres covered by reflecting film, 10 mm in diameter). 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 body landmarks. During the data acquisition protocol, the subject perform five trial for each upper limb of a determinate functional task for each session. Every subject repeat this operations 2 times with 2 different operators.

Pathological subjects

Subjects with a brain injury like cerebral phalsy or acquired brain injury

Group Type: EXPERIMENTAL

Upper limb 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 60 Hz. The experimental protocol require the positioning of markers (plastic spheres covered by reflecting film, 10 mm in diameter). 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 body landmarks. During the data acquisition protocol, the subject perform five trial for each upper limb of a determinate functional task for each session. Every subject repeat this operations 2 times with 2 different operators.

Interventions

Upper limb 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 60 Hz. The experimental protocol require the positioning of markers (plastic spheres covered by reflecting film, 10 mm in diameter). 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 body landmarks. During the data acquisition protocol, the subject perform five trial for each upper limb of a determinate functional task for each session. Every subject repeat this operations 2 times with 2 different operators.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• absence of functional impairments in the upper limbs

• Unilateral PCI candidates for CIMT (Constraint Induced Movement Therapy) treatment;
• Acquired brain injury candidates for CIMT or Bimanual treatment;
• Ability to understand and follow test instructions.

Exclusion Criteria

• behavioral, visual or auditory problems
• presence of pain in the upper limbs

For pathological group:

• behavioral, visual or auditory problems
• presence of pain in the upper limbs

• Minimum Eligible Age: 6 Months
• 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

1054

Identifier Type: -

Identifier Source: org_study_id