Effectiveness of Ankle-7 Orthosis vs HAFO Orthosis on Gait Performance in Diplegic Cerebral Palsied Children
Phase: NA
Conditions: Cerebral Palsy
Sponsor: Azienda USL Reggio Emilia - IRCCS

Date: 03092013 Version 0.2
Title of Project: 
Effectiveness of Ankle-7 orthosis vs AFO orthosis on gait performance in diplegic cerebral 
palsied children.
Protocol ID: UDGEE_2012_OTTObock
 
BACKGROUND  (knowledge  already  available  on  the  effectiveness  of  the  intervention)
The hypertonic muscle is a major cause of disability in children with cerebral palsy (PCI). A typical 
clinical  manifestation of PCI is  represented  by spastic diplegia,  affecting about 40% of this 
population. The movement disorder in children with CP results from the involvement of structures 
belonging  to  the  central  nervous  system  (top-down  components)  associated  with  variable 
involvement of structures belonging to the musculoskeletal system (bottom-up components). Both 
top-down and bottom-up components may provide clinical variables, the direct consequence of this 
phenomenon is that children with diplegia and PCI express more than one pattern of walking, 
different from the physiological one, each of which is characterized by more or less marked 
involvement of different muscles of the lower limbs.
The orthoses are frequently used to improve the ability of children with CP although, to date, the 
level of scientific evidence in support of their use is still limited. Improving the way through the 
most appropriate use of the orthoses requires the clinician with an understanding of spontaneous 
motor pattern and strategies adopted by the child during walking. To make a successful prescription, 
pathophysiology and pathological elements in the biomechanics of gait kinematics should be 
carefully considered and put into relation with the biomechanical characteristics of orthosis you 
have.
In recent years, we proposed a classification of spastic diplegia in childhood that can distinguish 
four different forms, according to the pattern of walking. (Ferrari et al, 2005) The second of these 
forms affects approximately 35% of children with diplegia and PCI and is characterized by knee 
flexing
 
in
 
mid-stance
 
and
 
sagittal
 
swinging
 
of
 
pelvis.
The classification of the forms of diplegia has already been tested for its inter-operator reliability 
(Ferrari et al, 2008) and the criterion validity (Ferrari et al, 2008). In choosing the most suitable 
orthosis, the clinician should try to integrate its objectives, in terms of improved kinematics and 
kinetics of the way, with the priority functional needs expressed by the child and the family, taking 
into account technical and economic constraints. The Ankle Foot Orthosis (AFO) is the most 
commonly used orthosis in diplegic PCI children. However, recently it has been proposed an 
orthosis  of  new  design that  contains  a carbon fiber  component whose  purpose is  to  store and 
return energy  during the  succession  of phases of  the  gait  cycle. The  effects  of  this 
orthosis in children  with diplegia and  PCI have  never  been studied nor  compared  with the 
effects of AFO in this population.
OBJECTIVES OF THE STUDY
- What the study aims to demonstrate:
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. The effectiveness of the orthosis will be evaluated objectively using gait analysis 
and
 
the
 
use
 
of
 
the
 
Goal
 
Attainment
 
Scale.

- What the study helps to add to current knowledge:
To date, there are no studies demonstrating the efficacy of ankle-7 orthosis on the walking function 
in this patient population. Furthermore, the level of scientific evidence to support the use of 
orthoses in spastic diplegia resulting from PCI, to date, is still limited. However, the use of orthoses 
in
 
this
 
population
 
is
 
widespread.
STUDY DESIGN
Monocentric
√
Complex
 
Structure
 
of
 
Rehabilitation  of  Severe  Developmental  Disabilities  - 
ASMN of Reggio Emilia (Italy)
Sponsored
Independent
√
Proposer:  UOC  Rehabilitation  of  severe  developmental 
disabilities,  Department  of  Obstetrics  -  Gynecology  - 
Pediatric
 
ASMN
 
Reggio
 
Emilia
The  study  is  funded  by  the  Company  OttoBock
The data are owned by the applicant and the structure of its 
affiliation
Study population
Children with PCI belonging to  the 2nd form of spastic diplegia, 
afferent  to  the  3rd  level  for  Severe  Developmental  Disabilities  at 
Hospital Santa Maria Nuova, Reggio Emilia, aged between 6 and 18 
years. To be included in the study, children must have a clinical and 
instrumental diagnosis of PCI, consisting of a complete medical history 
and results of magnetic resonance imaging.
According to our a hypothesis, the use of the ANKLE-7 orthosis will 
improve the power generated by the ankle joint during the push off. The 
data in our possession allows us to hypothesize that a minimum of 22 
cases must be selected to meet inclusion and exclusion criteria for a 
study  power  of  80%  with  a  Type  I  error  of  5%.  However,  this 
calculation is based on very few cases followed very heterogeneous 
amongst  themselves.  For  this  reason,  we  intend  to  proceed  to 
recruitment
 
in
 
two
 
phases.
In the first phase of "pilot" study, 5 children will be selected to meet the 
eligibility criteria for the study in order to more accurately identify the 
expected gain with the use of ANKLE-7 orthosis compared to the most 
common AFO articulated, on the outcome measure we consider to be 
our
 
main
 
and
 
secondary
 
measures.
In the second phase, after verification of the power and feasibility of the 
study, we will proceed to the completion of the sample.
N° of people involved in 
the center: 22
first phase 5, second 
phase to be verified, 
according to our initial 
hypothesis 17
Duration of the study:   from May 2012 to May 2014. 

Criteria for 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. 
Criteria for 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.
Outcome measures:
1_ power generated from the right and left ankle joints in the boost phase, measured by instrumental 
gait analysis
2_level of the knee joint kinematics: average extension in degrees of the right and left knees during 
initial contact, loading response and mid-stance calculated on a minimum of three walks or 15 
steps, measured by instrumental gait analysis;
3_ stride length sn and dx, measured by instrumental gait analysis;
4_ walking speed measured by instrumental gait analysis;
5_ energy expressed during the walking;
7_ preference of use of AFO or Ankle_7, determined from the diary;
8_ clinical evaluation of the walking function, through the video-recording of the same and the 
Visual Gait Assessment Scale (OGS). (Boyd R, Graham HK. 1999; Eur J Neurol 6: S23-S35)
An independent observer, with at least ten years of clinical experience in the field of PCI, blinded to 
the allocation of children in the two groups, observe the videotapes of each child while walking 
using O_1 or O_2 covered with gaiters and will give an assessment of clinical improvement or 
worsening of the second situation compared to the first. For this purpose we will use the OGS, a 
validated observational assessment scale of gait.
An independent observer, with at least ten years of clinical experience in the field of PCI, blinded to 
the allocation of children in the two groups, observe the graphical reports of instrumental gait 
analysis of every child while using O_1 or O_2 and will give an assessment of clinical improvement 
or worsening of the second situation compared to the first. 
Proposed intervention

The study is experimental and prospective, with a cross-over design.
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 hinged AFO orthosis (tailor-made with range of motion of about 20 ° (-5 - + 
15) from the indifferent position with ankle joint at 90 °) 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)
Hypothesis 
Superiority
Randomization 
YES  
Concealed allocation
Blinding
Single blind (assessor)
Study monitoring
Promoter