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

NCT03333434 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-06-12

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy

Interventions

DEVICE

Carbon Ankle Seven spring (A7 - Otto Bock, Germany)

DEVICE

Hinged AFO

Sponsors & Collaborators

  • Azienda USL Reggio Emilia - IRCCS

    lead OTHER_GOV

  • Otto Bock Healthcare Products GmbH

    collaborator INDUSTRY

Principal Investigators

  • Adriano Ferrari · University of Modena and Reggio Emilia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2017-05-15
Completion
2017-08-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03333434 on ClinicalTrials.gov