Metrological Properties of a Digital Motion Analysis Research Application for Assessing the Motor Abilities and Performance of Children With Cerebral Palsy

Обзор

Cerebral palsy is a common neurological disorder that is the leading cause of motor disability in children. It causes significant motor impairments, affecting various aspects such as fine and gross motor skills, as well as locomotion, which has a major impact on the quality of life of affected children. It is therefore essential to characterize these functional impairments in order to guide clinical decisions and maximize the motor function of affected children. Currently, the assessment of motor function is based on physical examinations and functional scales, such as the Gross Motor Function Classification System, which is specifically designed to assess children with CP. However, movement analysis using optoelectronic systems is considered the gold standard for this assessment, even though these systems have notable limitations (expensive installation, time-consuming use, and use only in a clinical environment, making it difficult to assess motor skills in children's everyday lives). In order to establish a comprehensive and personalized functional diagnosis, it is crucial to evaluate other fundamental motor tasks such as running, jumping, object control, and balance tasks. Recently, innovative markerless motion analysis technologies have been developed that allow analysis using smartphones or tablets outside of healthcare facilities. Therefore, developing an application dedicated to motion analysis for children with cerebral palsy that is easy to access and can be used frequently could yield many significant benefits.

Вмешательства

• Другое Assessment of functional abilities
  Gold standard
• Другое Children's self-questionnaires
  ABILOCO-Kids
• Другое Parent self-assessment questionnaires
  GOAL
• Другое Semi-structured interview
  Interview
• Другое Assessment of functional abilities
  Application

Первичные конечные точки

• Angle (in degrees) of knee flexion in sagittal view during a two-foot vertical jump using digital motion analysis software [Срок оценки: Up to 8 months]
• Angle (in degrees) of knee flexion in sagittal view during a two-foot vertical jump using the Gold Standard system (Motion Capture System). [Срок оценки: Up to 8 months]

Критерии участия

Критерии включения

Common to both groups:

• Obtaining free and informed consent from the child and at least one parent
• Children of all genders aged 6 to 18
• Children affiliated with or beneficiaries of a social security system

For the Cerebral Palsy group:

• Medical diagnosis of CP according to the SCPE (Surveillance of Cerebral Palsy in Europe) definition;
• Unilateral and bilateral impairment;
• Gross Motor Function Classification System (GMFCS) = I to III;
• No major cognitive or visual impairments that limit the performance of motor tasks

For the control group:

\- Children free from any disease

Other volunteers included in the protocol (qualitative analysis only (parents and clinicians)):

• Parent(s) of children with CP included in this study;
• Healthcare professionals and researchers involved in monitoring children with CP and/or evaluating the research application within the framework of this study

Критерии исключения

Common to both groups:

• Participants or parent(s) of participants who do not speak French
• Children subject to legal protection measures
• Pregnant or breastfeeding participants

For the Cerebral Palsy group:

• Presence of a cause of neuro-orthopedic disorders other than CP
• Limiting pain
• Surgical procedures performed less than 6 months prior to inclusion in the study
• Any other functional medical intervention that took place 3 months prior to inclusion in the study (e.g., botulinum toxin injections, plaster casts, etc.)
• Medical or surgical interventions planned between visit 1 and visit 2
• Children with a condition other than cerebral palsy that affects their walking ability

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Chu Dijon Bourgogne — Dijon

Идентификаторы

NCT: NCT07432789 · GUEUGNON THCS 2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗