Clinical Trials Directory

Trials / Completed

CompletedNCT03547674

Tuned Versus Untuned Ankle-foot Orthoses in Children and Adolescents With Cerebral Palsy

Tuned Versus Untuned Ankle-foot Orthoses in Children and Adolescents With Cerebral palsy_AFO-Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
5 (actual)
Sponsor
University Hospital, Basel, Switzerland · Academic / Other
Sex
All
Age
8 Years – 18 Years
Healthy volunteers
Not accepted

Summary

Cerebral palsy (CP) in children and adolescents is frequently accompanied by gait abnormalities. Ankle-foot orthoses (AFO) have been suggested to improve the gait pattern. Compared to conventional AFO, modular AFO offer the opportunity to tune its response to the patient's gait characteristics and/or functional maturity. However, the evidence level is still small and AFO tuning is not yet established in clinical routine. The study will investigate individual tuning of custom-built ankle-foot-orthoses (AFO) using gait analyses

Conditions

Interventions

TypeNameDescription
OTHERbarefootGait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order.
OTHERshoes onlyGait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order.
OTHERuntuned AFO with shoesGait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order. AFO are walking aids to improve gait pathologies. They are custom-built using plaster casts. AFO for equinus and/or drop foot pathologies are specifically indicated to control excessive ankle plantar flexion. Push-up elements that return the energy from the stance-phase to support lifting the foot during the swing-phase (similar to a spring) are used.
OTHERtuned AFO with shoesGait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order. Modular AFO tuning means that patients try different pushup elements with varying stiffness and design before the final design is determined.

Timeline

Start date
2019-01-01
Primary completion
2019-08-31
Completion
2019-08-31
First posted
2018-06-06
Last updated
2024-04-18

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT03547674. Inclusion in this directory is not an endorsement.