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

NCT03333434 | Terminated

• 1 other identifier: UDGEE_2012_OTTObock
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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 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

Outcome Measures

Primary Outcomes (1)

• 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

  Measured by instrumental gait analysis (ratio of watt to kilogram)

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

Secondary Outcomes (5)

• knee joint kinematics

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

• stride length

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

• walking speed

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

• preference of use of AFO or Ankle_7

  After a 4-6 week period of use of first orthosis, after a 4-6 week period of use of second orthosis and after 3 months after three months when the child could freely use both orthoses

• clinical evaluation of the walking function

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

Study Arms (2)

AFO - Ankle_7 group

OTHER

AFO is active comparator, ANKLE7 is the experimental treatment

Device: Carbon Ankle Seven spring (A7 - Otto Bock, Germany); Device: Hinged AFO

Ankle-7 - AFO group

OTHER

AFO is active comparator, ANKLE7 is the experimental treatment

Device: Carbon Ankle Seven spring (A7 - Otto Bock, Germany); Device: Hinged AFO

Interventions

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

AFO - Ankle_7 group; Ankle-7 - AFO group

Hinged AFO DEVICE

AFO - Ankle_7 group; Ankle-7 - AFO group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead
• Otto Bock Healthcare Products GmbH: collaborator

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Adriano Ferrari

  University of Modena and Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: November 7, 2017
• Study Start: November 30, 2012
• Primary Completion: May 15, 2017
• Study Completion: August 15, 2017
• Last Updated: June 12, 2025

Record last verified: 2017-11