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

NCT ID: NCT03333434

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2017-08-15

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.

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 data collection;

2. randomization by concealed allocation to one of the following two groups:

• AFO - Ankle_7 group
• Ankle-7 - AFO group Both, AFO and ankle-7, will be tailored to the patient

The two groups are distinguished by the order of the assignment of the two orthoses, respectively defined as the first assignment orthosis (O_1) and second assignment orthosis (O_2). The first group will use the orthoses AFO as a first assignment and then the orthoses Ankle_7, while the second group will use the two orthoses according to the reverse order. The two will be used with the same orthotic footwear, with the exception of the cases where it will be necessary to change it due to accretion.

3. collection of the measures necessary for making the two orthotic devices at OttoBock of Reggio Emilia

4. training in the use of the orthoses according to a standardized protocol;

5. try on the patient's in-process first assignment orthoses (O_1) and subsequent delivery of them (see Annex A);

Subsequently, the patient will use O_1 for a period of 4-6 weeks.

T1 - patients will receive the following procedures and assessments:

1. try on the patient's in-process second assignment orthoses (O_2)

2. instrumental gait analysis and video recording of the walking while using O_1 (covered by elastic gaiters);

3. withdrawal of O_1

4. delivery of O_2 to the patient

Subsequently, the patient will use O_2 for a period of 4-6 weeks.

T2 - patients will undergo the following procedures and evaluations:

1. instrumental gait analysis and video recording of the walking while using O_2 (covered by elastic gaiters);

2. return of O_1 to the patient;

3. Delivery of the diaries and directions for completing and mailing back them at the end of the follow-up period;

T3 - three months follow-up to detect the preference of use of AFO or Ankle-7 (by the child/parent)

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AFO - Ankle_7 group

AFO is active comparator, ANKLE7 is the experimental treatment

Group Type: OTHER

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

Intervention Type: DEVICE

Hinged AFO

Intervention Type: DEVICE

Ankle-7 - AFO group

AFO is active comparator, ANKLE7 is the experimental treatment

Group Type: OTHER

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

Intervention Type: DEVICE

Hinged AFO

Intervention Type: DEVICE

Interventions

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

Intervention Type: DEVICE

Hinged AFO

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otto Bock Healthcare Products GmbH

INDUSTRY

Sponsor Role: collaborator

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adriano Ferrari

Role: PRINCIPAL_INVESTIGATOR

University of Modena and Reggio Emilia

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

UDGEE_2012_OTTObock

Identifier Type: -

Identifier Source: org_study_id