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NCT Number: NCT07432789

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Assessment of functional abilities

Other

Gold standard

Children's self-questionnaires

Other

ABILOCO-Kids

Parent self-assessment questionnaires

Other

GOAL

semi-structured interview

Other

Interview

Primary outcomes

  1. Angle (in degrees) of knee flexion in sagittal view during a two-foot vertical jump using digital motion analysis software

    Time frame: Up to 8 months

    We will measure the left and right knees, which will be classified as either the most affected lower limb or the least affected lower limb in the PC group.

  2. Angle (in degrees) of knee flexion in sagittal view during a two-foot vertical jump using the Gold Standard system (Motion Capture System).

    Time frame: Up to 8 months

    We will measure the left and right knees, which will be classified as either the most affected lower limb or the least affected lower limb in the PC group.

Study contacts

Contact information is provided by the study sponsor or research team.

Paul ORNETTI

CONTACT

[email protected]

03.80.29.38.72 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: Valid-ABLE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 25, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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