TerminatedNot Applicable

Effectiveness Ankle-7 Orthosis VS HAFO Orthosis on Gait in Diplegic CPChildren

Stopped: Difficulties in recruiting

10 participantsStarted 2012-11-30

Plain-language 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 Ankle Seven spring (A7 - Otto Bock, Germany) is specifically designed to store energy when loaded and release it at toe-off in order to improve gait performance with respect to non-energy-storing AFOs. The aim of this work is to verify the superiority of the ankle-7 orthosis compared to the more widespread AFO, to improve the functionality and walking function of children with spastic diplegia and PCI.

Who can participate

Age range6 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \- 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 Criteria: * 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.

What they're measuring

Change from right and left ankle joints power generation in stance phase after the use of first orthosis to right and left ankle joints power generation in stance phase after the use of second orthosis

Timeframe: After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis

Trial details

NCT IDNCT03333434

SponsorAzienda USL Reggio Emilia - IRCCS

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2017-05-15

View on ClinicalTrials.gov More Cerebral Palsy trials