Functional Assessment Protocol for the Upper Limb for Pediatric Age

NCT06400667 | Active Not Recruiting

• 1 other identifier: 1054
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Extremity; Child; Range of Motion, Articular

Keywords

Kinematics; Upper limb; Motion analysis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Healthy subjects

EXPERIMENTAL

Subjects without upper limb disease

Device: Upper limb Kinematic Assessment with Optoelectronic system

Pathological subjects

EXPERIMENTAL

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

Device: Upper limb Kinematic Assessment with Optoelectronic system

Interventions

Upper limb Kinematic Assessment with Optoelectronic system 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.

Healthy subjects; Pathological subjects

Eligibility Criteria

• Age: 6 Months - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- absence of functional impairments in the upper limbs

You may not qualify if:

• behavioral, visual or auditory problems
• presence of pain in the upper limbs
• For pathological group:
• 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.
• behavioral, visual or auditory problems
• presence of pain in the upper limbs

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Location

Study Officials

• Giuseppe Andreoni

  IRCCS E. Medea - La Nostra Famiglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: May 6, 2024
• Study Start: May 18, 2023
• Primary Completion (Estimated): May 18, 2026
• Study Completion (Estimated): May 18, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-03

Locations

IT (1)