Clinical trial NCT06400667: Functional Assessment Protocol for the Upper Limb for Pediatric Age
Official title: Development of New Multifactorial Functional Assessment Protocols and Related Indices for Pediatric Age -Functional Assessment Protocol for the Upper Limb
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Extremity
Child
Range of Motion, Articular
Keywords: Kinematics
Upper limb
Motion analysis
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 20
Sex: ALL
Minimum age (years): 6
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: 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.

Eligibility criteria: For healthy group:

Inclusion Criteria:

- absence of functional impairments in the upper limbs

Exclusion Criteria:

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

For pathological group:

Inclusion Criteria:

* 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

Primary outcomes:
measure: Intra/Inter Operator Reliability
timeFrame: Through study completion, an average of 3 year
measure: Measures accuracy analysis
timeFrame: Year 1
measure: 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: