Status:

COMPLETED

Comparison of Conventionally Manufactured AFO and Modular Customized AFO

Lead Sponsor:

Beat Göpfert

Conditions:

Gait, Drop Foot

Eligibility:

All Genders

11-65 years

Phase:

NA

Brief Summary

The Investigator will investigate the difference in the gait pattern between 2 commercially available ankle foot orthoses (AFO): a) conventionally manufactured AFO and b) modular customized AFO using ...

Detailed Description

Cerebral palsy (CP) is the most common movement disorder in children \[Stavsky, 2017\]. It is frequently accompanied by spasticity \[Baker, 2009\]. The typical symptoms of spastic cerebral palsy are g...

Eligibility Criteria

Inclusion

  • Participants fulfilling all of the following inclusion criteria are eligible for the study:
  • Patients (11-18 yrs.), who need a new orthosis (visit to an orthopedic technician)
  • Patients (18-65 yrs.), who need a new orthosis (visit to an orthopedic technician)
  • Informed Consent provided as documented by signature
  • Confirmed diagnosis of cerebral palsy
  • Confirmed diagnosis of spastic equinus and/ or drop foot,
  • Gait pathologies treated with conventional AFO
  • Gross Motor Function Classification System (GMFCS) level I or II

Exclusion

  • Other neuromuscular diseases
  • Surgical intervention lower extremities past 12 months to improve gait pathologies
  • Injections of Botulinum toxin 6 months prior to study inclusion
  • Inability or unwillingness to follow the procedures of the gait analysis
  • in women: pregnancy

Key Trial Info

Start Date :

February 25 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 31 2024

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT05192915

Start Date

February 25 2022

End Date

January 31 2024

Last Update

December 5 2024

Active Locations (1)

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1

University of Basel

Basel, Canton of Basel-City, Switzerland, 4000