Status:
TERMINATED
Effectiveness Ankle-7 Orthosis VS HAFO Orthosis on Gait in Diplegic CPChildren
Lead Sponsor:
Azienda USL Reggio Emilia - IRCCS
Collaborating Sponsors:
Otto Bock Healthcare Products GmbH
Conditions:
Cerebral Palsy
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
Ankle foot orthoses (AFO) are frequently used to improve locomotor skills of cerebral palsied children (CP) although the level of scientific evidence to support their use is still moderate. Carbon Ank...
Detailed Description
The project is divided into the following phases: T0 - at the beginning of the study children included will be subject to the following procedures and assessments: 1. demographic and anthropometric ...
Eligibility Criteria
Inclusion
- \- Clinical indication to the use of orthoses to improve the walking function confirmed by instrumental parameters obtained from analysis of the path (dynamic electromyography, optoelectronic stereophotogrammetry analysis);
- Patients who already have AFO orthoses (or ankle-7) that need to be renewed;
- Patients with new clinical indication to the use of orthoses but not yet in possession of the same;
- Informed consent from parents / guardians of the child
Exclusion
- Cognitive disabilities that may affect the child's participation in the activities related to this study, in the opinion of the investigators;
- Lower limbs sensory disability that may affect any beneficial effects of the use of the orthoses, in the opinion of the investigators;
- Other diseases associated or not associated with PCI that, according to investigators, could affect the child's participation in the activities related to this study (eg: drug-resistant epilepsy);
- Administration of antispasmodic drugs in the last 6 months;
- Functional surgery of the lower limbs in the last 6 months;
- Indication for surgical treatment to be carried out within 6 months after the date of inclusion in the study.
Key Trial Info
Start Date :
November 30 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03333434
Start Date
November 30 2012
End Date
August 15 2017
Last Update
June 12 2025
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