Functional Assessment Protocol for the Upper Limb for Pediatric Age

Child Clinical Trial

Official title:

Development of New Multifactorial Functional Assessment Protocols and Related Indices for Pediatric Age -Functional Assessment Protocol for the Upper Limb

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06400667
• Other study ID #: 1054
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2023
• Est. completion date: May 18, 2026

Study information

• Verified date: May 2024
• Source: IRCCS Eugenio Medea
• Contact: Giuseppe Andreoni
• Phone: 031877350
• Email: giuseppe.andreoni[@]lanostrafamiglia.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 18, 2026
• Est. primary completion date: May 18, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Child
• Range of Motion, Articular
• Upper Extremity

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Italy	IRCCS E. Medea	Bosisio Parini	Lecco

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra/Inter Operator Reliability	In the intra and interoperator repeatability analysis the investigators considered the correlation coefficient for the average RoM (in the 5 trials) in corresponding sessions. In particular, the investigators referred to standard interpretation criteria: the ICC values 0.5 and 0.75 indicate moderate reliability, values between 0.75 and 0.9 indicate good reliability, and values greater than, 0.90 indicate excellent reliability	Through study completion, an average of 3 year
Primary	Measures accuracy analysis	For the accuracy analysis, the comparison between the reference measures and the measure obtained with the optoelectronic system for every segment of the spine was assessed through the root mean square error.	Year 1
Primary	Usability assessment	About the usability assessment, the System Usability Scale (SUS) collected at the end of each acquisition and calculated the average score value. The SUS provides a reliable tool for measuring the usability. The SUS questionnaire consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree	Through study completion, an average of 3 year