3rd Journal Reading

Friday, September 16, 2016

An Individual Approach for

Optimizing Ankle-foot Orthoses to
Improve Mobility in Children With
Spastic Cerebral Palsy Walking With
Excessive Knee Flexion
Yvette L. Kerkum, Jaap Harlaar , Annemieke I. Buizer ,
Josien C. van den Noort, Jules G. Becher, Merel-Anne
Brehm

Presented by :
Novaria Puspita, dr.

Supervised by :
Dr. Med. Sc. Irma Ruslina Defi, dr., Sp. KFR(K)

Introduction
Children with celebral palsy
(CP) have a wide variety of
motor
impairments
(e.g.
Spasticity
and
muscle
weakness), often resulting in
gait
deviations,
such
as
excessive
knee
flexion
in
Interventions
primarily aim to
stance
reduce knee flexion to prevent
deterioration,
which
could
improve gait efficiency and
walking activity in daily life
Ankle-Foot Orthosis (AFO) is
designed to improve the most
important deviation in gait
biomechanics, while adverse
effects on other gait features
should be minimized

Objective
to investigate whether the efficacy of a ventral shell AFO
(vAFO) to reduce knee flexion and walking energy cost
could be improved by individually optimizing AFO
stiffness in children with CP walking with excessive knee
flexion
to investigate the effect of the optimized vAFO on daily
walking activity

Study Design
A pre-post experimental study
consisting of two repeated measurements;
T0 : at baseline walking with shoes only
T2 : 12-20 weeks follow-upwalking with the optimized vAFO
T1 : Additional measurements were performed to provide data for
the optimal AFO stiffness selection consisted of a period of 3
months (starting directly after T0), in which children wore three
different AFO stiffness levels (i.e. Rigid, stiff, and flexible, applied
in random order) for four weeks each

Participants
Inclusion Criteria
Children diagnosed with spastic
CP who were indicated for a
new AFO
Age between 6-14 years old
Classified with a Gross Motor
Function Classification System
Level I, II, or III
Presented a barefoot gait
pattern that was characterized
by excessive knee flexion in
stance (i.e. >10 degrees Knee
flexion at midstance)

Exclusion Criteria
Children who had hip and/or
knee flexion contractures of
>10, as these have been
shown to impede the effect
of vAFOs

Intervention
For shoes-only measurement, participants wore their own
shoes
Children were prescribed with a vAFO with a full-length stiff
footplate, which were worn in sneakers with a flat flexible soles
The vAFO were made out of pre-preg carbon fibers and
manufatured with an integrated hinge
Different springs can be inserted into hinge, allowing the AFOs
mechanical properties to be varied, such as the AFO stiffness
For each participant, the hinge was randomly set into three
stiffness configurations (i.e. Rigid, stiff and flexible)
The effect of each configuration on gait were evaluated.

Intervention
The optimal AFO stiffness was selected (T1which based
on ranking the vAFOs effect on knee extention (KE) and
gait efficiency (i.e. Walking energy cost) Appendix A
Outcome was assessed after three months of wearing the
optimized vAFO

Picture of the spring-hinged ventral shell Ankle-Foot Orthosis, including possible adjustments
using the hinge
Figs adapted from Fior & Gentz.

OUTCOME
MEASURES
Primary

Secondar
y

Walking energy cost

(6 minute rest test and 6 Minute
walk test)

Daily walking activity (SAM)

Knee angle (degree)
Ankle Power (Weight/kg)
Additionally, compliance to
the optimized vAFO was
measured

Biaxial
Stepwatch
Activity
Monitor 3.0
(SAM)

StepWatch Activity Monitor3

OrthoCare Innovations (Oklahoma
City, Oklahoma)
Attached near ankle with strap
Data capture up 2 months, at oneminute intervals

Data Processing
To calculate walking energy cost :
Breath-by-breath VO2 and VCO2 values from minutes three to six of
the rest and the walk test were used to determine the mean steadystate energy consumption values (ECSrest and ECSwalk).
The net energy cost (EC) was calculated as : (ECSwalk
ECSrest)/walking speed
Regarding the SAM, data were excluded from the analysis if (i) >3 h of
data were missing within the time interval of being awake, and (ii) a day
had less than eight hours of registration time
For gait analysis, optoelectronic marker data and force plate data of
three trials of the most affected leg were analyzed using custom-made
software (Bodymech, www.bodymech.nl).

Statistical
Analysis

The sample size for this study was based on a power analysis
of the expected changes in the net EC (i.e. shoes-only versus
stiffness optimized vAFO) assuming a power of 80%
a significance level of 0.05

Participant flow & Recruitmen

210 out of 228 children did not meet the inclusion criteria, the majority was
excluded based on age and gait pattern
32 children were invited to participate, of which 18 children were enrolled in the
study
Two participants dropped out as the measurements were too demanding and one
participant the had too many problems with the fitting of the vAFOs

Accordingly, data of 15 children (29 limbs)

were included in the analyses.

Participa
nt flow &
Recruitm
ent

Fig. 1. Study flowchart. The

allocation of the different
degrees of stiffness (i.e. rigid
(K1), stiff (K2), and flexible
(K3)) was block-randomized:
B1B6 represent the different
blocks. Abbreviations: vAFO,
ventral shell Ankle-Foot

Participant Demographic

Optimal Stiffness Selection

Ranking of the vAFO based on its effect on KE resulted in an immediate decision
for 7 out of 29 legs, of which :
1 was prescribed with the rigid,
3 with the stiff, and
3 with the flexible vAFO as most optimal
Based on SMC-EC, :
the stiff (n = 14) and
flexible (n = 8)
vAFO were prescribed as most optimal for the remaining legs

At the moment of selecting the optimal stiffness (T1), the optimized

vAFO reduced the net EC in all participants, resulting in a median [IQR]
net EC of 4.8 [1.5] J kg m 1, accounting for a 20% decrease compared
to baseline

Effect of the Optimized vAFO

Walking energy cost data of one participant was excluded from analysis, because
equipment failed during the measurement
At follow-up, 11 out of 14 children showed a decease in net EC compared to
baseline, resulting in a median reduction of 9% (p = 0.077) for walking with the
optimized vAFO compared to shoes-only
The optimized vAFO did not affect walking speed (p = 1.000)
Total daily stride rate was not affected by the optimized vAFO compared to
baseline on any of the stride rate frequencies (p = 0.148)

Effect of the
Optimized vAFO
The Peak Knee Extention (KE)/reduced knee flexion by 2.4 0 (p =
0.006) compared to walking shoes-only
The peak ankle power generation was not significantly reduced (p
= 0.064)
The optimized vAFO was worn for median [IQR] of 8.9 [5.0]
hours/day

DISCUSSION
significantly reduced knee flexion by 2.40 on average
some children avoided knee extension, and thus stretching of the calf
muscles, by walking on the tip of the rigid vAFOs footplate the
persistent knee flexion
Rigid vAFOs are stiff enough to allow such a walking pattern
suggested that spring-hinged vAFOs are more suited to improve knee
extension, and subsequently prevent development of muscle
contractures and improve gait efficiency knee flexion by 2.48 on
average

DISCUSSION
9% decrease in the net EC compared to shoes-only. Several factors
might explain this smaller decrease :
the mechanical properties of the vAFO may have changed over time,
therewith less effectively reducing knee flexion
the participants development (e.g. growth) could have interfered with
the vAFOs effect on net EC
unjustified assignments of an optimal stiffness could have occurred
11 out of 14 subjects showed a decrease in their net EC while walking
with the optimized vAFO at follow-up, where five subjects showed a
decrease of >10%, indicating that individually optimizing AFO stiffness
clinically meaningful changes

Limitation
The lack of statistical significance and the absence of a larger effect on
net EC is most likely related to the small sample size, as the study was
underpowered
very specific inclusion criteria restricted the enrollment of children into
the study

Conclusion
The study in children with CP who walk with
excessive knee flexion shows that individually
optimizing vAFO stiffness significantly
improves the gait pattern by a reduced knee
flexion in stance
Data suggest that gait efficiency can also be
improved
An optimal stiffness emphasizes the
importance of an individual approach to AFO
prescription in CP to maximize its effects on
the gait pattern and gait efficiency

Criteria

Yes

No

Other
(CD, NR, NA)*

1. Was the study question or objective clearly stated?

2. Were eligibility/selection criteria for the study population
prespecified and clearly described?
3. Were the participants in the study representative of those
who would be eligible for the test/service/intervention in the
general or clinical population of interest?
4. Were all eligible participants that met the prespecified
entry criteria enrolled?
5. Was the sample size sufficiently large to provide confidence
in the findings?
6. Was the test/service/intervention clearly described and
delivered consistently across the study population?
7. Were the outcome measures prespecified, clearly defined,
valid, reliable, and assessed consistently across all study
participants?
8. Were the people assessing the outcomes blinded to the
participants' exposures/interventions?
9. Was the loss to follow-up after baseline 20% or less? Were
those lost to follow-up accounted for in the analysis?
10. Did the statistical methods examine changes in outcome
measures from before to after the intervention? Were
statistical tests done that provided p values for the pre-topost changes?
11. Were outcome measures of interest taken multiple times
before the intervention and multiple times after the
intervention (i.e., did they use an interrupted time-series
design)?
12. If the intervention was conducted at a group level (e.g., a

NA

SVA