Hôpital Raymond Poincaré - Service Neurologie Pédiatrique Médecine Physique et Réadaptation
Garches, 92380, France
NCT Number: NCT07301593
Children with cerebral palsy (CP) present a variety of motor impairments and activity limitations. Plastic ankle-foot orthoses (pl-AFO) are frequently prescribed to improve their gait. However, their use limit forward propulsion generation, which explains why children tend to remove their pl-AFO during recreational activities,including running and jumping. While the benefits of physical activity are proven for these children, there is no data about pl-AFO impact across a range of locomotor activities. Biomechanically optimized dynamic carbon fiber AFOs (c-AFO) are now available and may improve propulsion features in comparison with usual pl-AFOs. The investigators aim to compare the AFO-specific effects (pl-AFO vs c-AFO) on propulsion (during walking, running and jumping), to explore the consequences on social participation, as well as to evaluate the effect on the hemiparetic CP child's perception and adherence of wearing each AFO. In this prospective, multicenter, randomized controlled trial with a crossover design, 38 hemiparetic CP children from 8 to 15 years old will be evaluated with their usual pl-AFO and with a c-AFO. The pragmatic clinical approach of this study is expected to provide data to guide and optimize AFO prescription and use, while enhancing understanding of these devices and their adaptation to the actual physical activity of CP children.
Trial opening soon.
Get Notified8 year–15 year
All sexes
Interventional
Not applicable
Garches, 92380, France
This study is a randomized controlled trial with a crossover design. A total of 38 patients will be recruited from three different centers.
Each participant will be randomly assigned to one of two groups (Group c/pl or Group pl/c). Depending on the group allocation, each subject will test both types of ankle-foot orthoses (AFOs) in a different order.
Each evaluation includes:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
within the past 6 months prior to inclusion if no bony procedure was performed, or within the past 12 months prior to inclusion if a bony procedure was performed, or who have a planned surgical procedure during the study period.
Participants assigned to this group will wear the c-AFO for a 4-week intervention period. Outcome assessments will be conducted at baseline and at the end of the 4-week period. Following a 2-week washout phase, participants will then wear the pl- AFO for an additional 4 weeks, with identical outcome assessments performed at the corresponding baseline and endpointPlastic ankle foot orthosis or carbon ankle foot orthosis
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.
Anteroposterior component of the ground reaction force (GRF), recorded during running, using force plates
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.
Propulsion forcesduring jumping and walking (force plates)
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.
Kinematics parameters during running, jumping and walking
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period
Spatiotemporal parameters during running, jumping and walking: Step length, foot clearance, single and double support time, flight phase duration during running and jump height.
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.
Running endurance (using the 10 Meters Shuttle Run Test)
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period
Items D and E of the Gross Motor Function Measure, with a total score ranging from 0 to 111.
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period
Participation in physical activities, using the Children and Adolescent Physical Activity and Sedentary Questionnaire. The questionnaire includes two subscales: physical activity, scored from 1 to 4, and sedentary behavior, scored from 1 to 6
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period
By a Follow up booklet
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period
By a follow up booklet
Contact information is provided by the study sponsor or research team.
Isabelle MEDERER
CONTACT
Julie BARRADAS
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Acronym: DynamicPC
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.
Published trials that share one or more normalized conditions with this study.
NCT07732205
Brain Damage, Chronic, Brain Diseases
Budapest, Pest County, Hungary
View Trial DetailsNCT07469514
Brain Damage, Chronic, Brain Diseases
Oakland, California, United States
View Trial DetailsNCT07702786
Brain Damage, Chronic, Brain Diseases
View Trial DetailsNCT07683455
Behavior, Brain Damage, Chronic
View Trial Details