R E S E A R C H A R T I C L E

Effects of AFO Use on Walking

in Boys With Duchenne Muscular
Dystrophy: A Pilot Study
Elise L. Townsend, PT, DPT, PhD, PCS; Himani Tamhane, PT, DPT, MS; K. Douglas Gross, PT, DPT, ScD, FAAOMPT, CPed
Department of Physical Therapy, School of Health and Rehabilitations Sciences (Drs Townsend and Gross), MGH
Institute of Health Professions, Boston, Massachusetts; Massachusetts General Hospital (Dr Townsend), Boston,
Massachusetts; Boston University School of Medicine (Dr Gross), Boston, Massachusetts; Health East Medical Center
(Dr Tamhane), Englewood, New Jersey.

Purpose: Although bracing in the late ambulatory stage of Duchenne muscular dystrophy (DMD) has been
described, the effects of ankle-foot orthoses (AFOs) in earlier stages have not been evaluated. The aim of
this pilot study was to describe the effects of dynamic response AFO (DR-AFO) use in boys with DMD who are
ambulatory. Methods: Using a crossover design, 3 boys were randomly assigned to either a 2-week DR-AFO
or a placebo intervention. Phases were separated by a 1-week washout period. Primary outcomes were time
to walk 10 m and a 6-Minute Walk Test. Results: With DR-AFO use, declines in 10-m walk time (median
decline = 0.8 s) and 6-Minute Walk Distance (median = 25.0 m) occurred. Parental report suggested that
the use of DR-AFOs increased falls in 2 of 3 participants. Conclusion: This pilot study does not support the
use of DR-AFOs by boys with DMD who are ambulatory. (Pediatr Phys Ther 2015;27:24–29) Key words: child,
Duchenne muscular dystrophy, foot orthoses, gait, male, physical endurance, walking

Duchenne muscular dystrophy (DMD) is an X-linked
recessive genetic disorder characterized by progressive
muscle weakness that affects functional mobility and par-
ticipation of boys with DMD, generally by the age of 5
years. Proximal weakness of pelvic, hip, and quadriceps
muscles occurs earliest and is more pronounced than dis-
tal lower extremity and upper extremity weakness. Gait
0898-5669/110/2701-0024
Pediatric Physical Therapy
Copyright C 2015 Wolters Kluwer Health | Lippincott Williams &
Wilkins and Section on Pediatrics of the American Physical Therapy
Association
Correspondence: Elise L. Townsend, PT, DPT, PhD, PCS, Department
of Physical Therapy, School of Health and Rehabilitations Sciences,
MGH Institute of Health Professions, 36 1st Avenue, Boston, MA 02129.
(etownsend@mghihp.edu).
Grant Support: This study was supported by a Marjorie K. Ionta
Grant from the MGH Institute of Health Professions awarded to Himani
Tamhane.
The authors declare no conflict of interest.
At the time this study was completed, Himani Tamhane was a Master
of Science student in the Department of Physical Therapy, School of
Health and Rehabilitations Sciences, MGH Institute of Health Professions,
Boston, MA, USA.
DOI: 10.1097/PEP.0000000000000099
is typically characterized by widened step width, shorter
step length, impaired ankle and hip power, accentuated
anterior pelvic tilt with lumbar lordosis, knee recurvatum
in stance phase of gait and excessive hip abduction and
ankle plantar flexion during swing phase.1 Other common
gait compensations for weakness and instability include
enhanced lateral trunk lurch, upper extremity abduction,
and toe walking.2 Current medical management includes
long-term corticosteroids, which may extend ambulation
for 1 to 3 years,3-5 particularly if the development of plan-
tar flexion contractures can be avoided. Even with optimal
management, slowed, unsteady gait with limited walking
endurance is evident by the age of 7 to 9 years, and loss of
ambulation by the age of 13 years is expected.6
Orthotics used in the management of DMD in-
clude knee-ankle-foot orthoses and ankle-foot orthoses
(AFOs). Although knee-ankle-foot orthoses may help pro-
long walking in the late ambulatory stage for some boys
with DMD, their use is associated with reduced walking
speed, increased difficulty in stair climbing, and the need
7-8
for manual assistance to prevent falls. Resting AFOs for
day or night wear help maintain or slow the loss of ankle
plantar flexor muscle length and are an important stan-
dard of care for boys with DMD.9 However, solid ankle or
hinged AFOs (eg, polypropylene) with a posterior shell are

24 Townsend et al Pediatric Physical Therapy

Copyright © 2015 Wolters Kluwer Health | Lippincott Williams & Wilkins and the Section on Pediatrics of the American Physical Therapy
Association. Unauthorized reproduction of this article is prohibited.
 generally not recommended for ambulation in boys with
DMD because they fail to provide knee stability and restrict
the use of active ankle strategies for balance with standing
and walking.10 The added weight of traditional AFOs can
further challenge weakened hip muscles and may exacer-
bate micro-injury of weakened knee extensors during the
eccentric loading phase of gait.8
Advances in orthotic design led to development of
a lightweight, carbon-composite dynamic response AFO
(DR-AFO), which, unlike the traditional solid or hinged
AFO, uses an anterior tibial shell thought to assist with
knee extension in the mid-stance phase of gait, without
preventing inversion and eversion at the ankle. This design
aims to reduce proximal joint stresses and assist in overall
gait stability. Dynamic response AFOs were designed to use
energy stored at heel strike to provide an additional push
at toe off and facilitate forward progression.11 Although
industry-sponsored research supports the effectiveness of
DR-AFOs for ambulation in adults with stroke,12 no stud-
ies have examined the effectiveness of DR-AFOs to aid
ambulation in children with progressive neuromuscular
conditions.
The objective of this pilot study was to assess the fea-
sibility and potential value of future trials and to make a
preliminary evaluation of the effects of DR-AFOs on func-
tional mobility and gait in boys with DMD. Our primary
aim was to explore how DR-AFO wear affects walking
abilities over both household and community distances.
A secondary aim was to explore the effects of DR-AFO
wear on the challenging functional tasks of stair climbing
and rising from the floor, as well as on spatiotemporal gait
parameters and fall frequency.
METHODS
Participants
Three boys with a physician-confirmed diagnosis of
DMD were recruited through the Pediatric Neuromuscu-
lar Clinic at the Massachusetts General Hospital. Eligible
participants were aged 5 to 11 years, had a diagnosis of
dystrophinopathy, and were able to ambulate 100 feet or
more without resting. Exclusion criteria were the follow-
ing: (1) attention, language, or cognitive disabilities that
limited study participation; (2) ankle plantar flexion con-
tracture(s) greater than 10◦ that prevented proper orthotic
fitting; or (3) ambulation with AFOs at baseline. One par-
ticipant was excluded for a plantar flexed, supinated an-
kle/foot with contracture. The study was approved by the
hospital’s Institutional Review Board. Informed consent of
the parent/guardian and assent of the child participants
were obtained prior to initiation.
Study Design
A randomized crossover design was used to compare
the effects of a DR-AFO (Figure 1; KiddieGAIT, Allard,
USA) to the effects of a placebo neoprene ankle sleeve.
The design involved two 2-week intervention phases
Pediatric Physical Therapy
Copyright © 2015 Wolters Kluwer Health | Lippincott Williams & Wilkins and the Section on Pediatrics of the American Physical Therapy
Association. Unauthorized reproduction of this article is prohibited.
Fig. 1. Dynamic response AFO (DR-AFO).
(1 and 2), separated by a 1-week washout phase, and fol-
lowed by a 2-week open label period (Figure 2). During
phase 1, participants were randomly allocated to use ei-
ther the DR-AFO (condition sequence A) or the placebo
neoprene ankle sleeve (condition sequence B). Both inter-
ventions were applied bilaterally. Randomized allocation
was conducted using a Web-based random number gener-
ator to assign the sequence of conditions. In the washout
phase, participants remained intervention free for 1 week.
During phase 2, participants used the alternate orthotic.
In the open label period, participants wore the preferred
orthotic for 2 weeks, which afterward they could keep
and continue to use. A total of 5 assessment visits oc-
curred across the 7-week study period. Visits occurred at
baseline and at the end of each phase (phase 1, washout,
phase 2, and open label). Although complete blinding to
intervention condition was not possible, the evaluator was
blinded to the sequence of intervention for each child.
Participants were told only that the effects of 2 differ-
ent types of intervention were being explored. Participants
wore their usual shoes, which were lightweight, well-fitting
sneakers with tie or velcro closure. Orthotics were do-
nated for the purpose of the study and were fitted and ad-
justed in conjunction with a certified orthotist experienced
with DR-AFOs and DMD, based on the published instruc-
tions of the manufacturer (http://www.allardint.com/pdf/
droppfot/Professional ToeOFF Family AINT.pdf).
Outcome Measures
Primary outcome measures were the following: (1)
time (s) to walk 10 m and (2) distance (m) covered
in a 6-Minute Walk Test, both commonly used as out-
come measures in ambulatory DMD trials, and with es-
tablished reliability, concurrent validity, responsiveness
Washout
Phase 1 phase Phase 2 Open label
(2 weeks) (1 week) (2 weeks) (2 weeks)
DR-AFO DR-AFO
A B
B Placebo Placebo
A
Fig. 2. Crossover study design. DR-AFO, dynamic response ankle-
foot orthosis. This figure is available in color in the article on the
journal website, www.pedpt.com, and iPad.
AFO Use in Boys With Duchenne Muscular Dystrophy 25
 to change, and clinical meaningfulness.6,13-16 The 10-
Meter Walk Test was chosen to index short-duration walk-
ing speed of household distances. The 6-Minute Walk
Distance (6MWD) was chosen to index community walk-
ing endurance, with established modifications for boys
with DMD that included verbal encouragement during
walking to maintain attention to task and a “safety chaser”
to walk behind the participant and manage losses of bal-
ance and/or falls.16 Secondary outcome measures included
(1) timed functional tests of rising to stand from supine
and climbing 4 stairs, both reliable and responsive mea-
sures of function in boys with DMD that have been used
as secondary outcomes in DMD clinical trials6,13,15 ; (2)
spatiotemporal gait parameters including velocity at a self-
selected walking speed, step width, and stride length; and
(3) fall frequency via parental log. Logs also included
days/hours of orthotic use, reports of pain/discomfort with
wear, and skin problems.
The order of testing and the durations of rest intervals
between tests and procedures were standardized. Timed
functional tests were measured in seconds using a digital
stopwatch. The better of 2 trials was selected for analy-
sis. Spatiotemporal gait parameters were measured using a
4.9 m GAITRite instrumented walkway system (CIR Sys-
tems, Inc, Havertown, PA), which consists of a plastic and
rubber mat imbedded with pressure sensors that record
footprints. This system has been used with excellent re-
liability and validity in children with motor disabilities.17
Proprietary GAITRite Software (version 3.9) was used to
calculate walking velocity, stride length, and step width,
averaged over 4 walking trials. Start and stop lines for each
trial were placed 1 m before and after the GAITRite mat
so that the initial accelerating and decelerating steps were
excluded.
Data Analysis
Individual difference scores representing change be-
tween the start (baseline, no intervention) and the end
(with intervention) of each phase were calculated and
used to identify median change for each outcome measure.
Participant (P1-P3) Characteristics and Fall Frequency During Intervention With a Dynamic Response AFO (DR-AFO) and During Intervention
Age, y
Height, inch
Weight, lb
Corticosteroid type and dose schedule Prednisone 10 days on/10 off
Baseline functional level (Vignos Scale)
Mean hours per day DR AFO wear
Mean hours per day placebo wear
Falls during 2-week DR AFO wear
Falls during 2-week placebo wear
Falls during 1-week washout phase
Bracing choice in open label period DR AFOs
Abbreviation: DR-AFO, dynamic response ankle-foot orthosis.
26 Townsend et al
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Association. Unauthorized reproduction of this article is prohibited.
The median was chosen as a measure of central tendency,
given the small sample size, high variability of scores, and
skewed distributions.18 Inferential statistical tests were not
attempted for this small pilot study sample, although de-
scriptive comparisons of median change under the 2 inter-
vention conditions were informative when assessing the
potential need for, and feasibility of, future trials.
RESULTS
Three boys with DMD aged 5 to 11 years partici-
pated in this pilot study. All participants were receiving
glucocorticoid therapy (for steroid medication and dosing
schedule see Table 1) and were independently ambulating
in the community, with functional levels ranging from 2
to 3 on the Vignos functional rating scale.19 Change in
outcomes with DR-AFO or placebo use are described here
and reported in Table 2.
Tolerance
All participants were able to attain at least 3 consec-
utive days of 9 hours daily wear of DR-AFOs. Duration
of wear over the 2-week intervention phase ranged from
2 to 11 hours per day (mean = 5.0) for DR-AFOs and 5
to 10 hours per day (mean = 8.0) for the placebo. Indi-
vidual intervention time means are reported in Table 1.
By parent and participant report, negative factors related
to DR-AFO wear included more difficulty rising from the
floor and climbing stairs and hills and minor skin itch-
ing/discomfort. Negative factors related to placebo wear
were limited to mild itching and sweating of feet.
Primary and Secondary Outcomes
Timed Tests. Individual performance data for timed
test outcomes are presented in Table 2. With DR-AFO use,
median time taken to walk 10 m increased (median in-
crease = 0.8 s [range 0.7-3.4]), whereas median 6MWD
decreased (median decrease = −25.0 m [range −44.0
to 18.8]). Median time to rise from the floor was also
increased with DR-AFO wear (median increase = 2.7 s
TABLE 1
With a Placebo Ankle Sleeve
P1 P2 P3
8 5 11
47 47 55
42 40 88
Deflazacort 10 days on/10 off Deflazacort daily
3 2 2
3.6 6.4 5.1
7.3 9.2 7.4
6 12 1
5 0 1
2 4 2
Placebo Placebo
Pediatric Physical Therapy
 TABLE 2
Individual and Group Median Change Timed Functional Test Performance Between Baseline and Intervention With a Dynamic Response Ankle-Foot
Orthosis (DR-AFO) and Between Baseline and Intervention With Placebo

Dynamic Response Ankle-Foot Orthosis Placebo

Outcome Participant Baseline Intervention Change Baseline Intervention Change

10-m walk, s P1 8.5 11.9 +3.4 8.5 8.0 − 0.5

P2 7.1 7.9 +0.8 8.1 8.2 +0.1
P3 6.4 7.1 +0.7 6.1 6.5 +0.4
Median +0.8 +0.1
6-Minute Walk Distance P1 318.8 293.8 − 25.0 300.0 256.3 − 43.3
(6MWD), m P2 325.0 281.0 − 44.0 218.8 325.0 +106.3
P3 456.3 475.0 +18.8 400.0 406.3 +6.3
Median − 25.0 +6.3
Rise from floor, s P1 9.8 14.2 +4.4 7.6 7.8 +0.2
P2 5.1 7.8 +2.7 4.8 5.7 +0.9
P3 8.3 7.5 − 0.8 6.6 8.0 +1.4
Median +2.7 +0.9
4 stair climb, s P1 12.7 19.2 +6.5 6.3 21.0 +14.7
P2 6.0 8.2 +2.2 8.8 10.6 +1.8
P3 3.8 6.2 +2.4 3.6 4.2 +0.6
Median +2.4 +1.8

[range −0.8 to 4.4]), as was time to climb 4 stairs (median
increase = 2.4 s [range 2.2-6.5]). Although these findings
are consistent in suggesting worsening walking speed, en-
durance, rise from the floor time, and stair climb time with
DR-AFO use, it is worth noting that high variability in per-
formance was evident for timed tests, both within a single
participant across multiple baseline (no intervention) tests
and across different participants in terms of the magnitude
and/or direction of DR-AFO effects on performance. All
3 boys demonstrated slowed 10-m walk and stair climb
times with the DR-AFO intervention, and 2 of 3 showed
a decrease in performance in 6MWD and rise from the
floor time. However, 1 participant (#3) showed nominally
improved performance in 6MWD and rise from the floor
time in the setting of high baseline variability. Quantita-
tive evaluation of stability in baseline performance showed
that 10-m walk time was the least variable (median base-
line difference = 0.3 s [range 0.0-1.0]). Median baseline
differences for 6MWD, rise from floor time, and 4 stair
climb time were 56.3 m (range 18.8-106.2), 1.7 s (range
0.3-2.2), and 2.8 s (range 0.2-6.4), respectively.
Gait Characteristics. Individual data for gait char-
acteristics are presented in Table 3. Dynamic response
AFO wear slowed self-paced median walking velocity in
3 of 3 boys (median = −2.4 cm/s [range −4.5 to 21.7]).
Although walking speed was slower with DR-AFO use,
both median stride length and median step width were
increased (median stride length = 3.5 cm [range −5.8 to
19.9]; median step width = 1.0 cm [range −0.2 to 2.0]),
perhaps indicative of a more halting and unbalanced gait
with DR-AFO use.
Fall Frequency. All participants reported experienc-
ing at least 1 fall during the 1-week washout (no inter-
vention) phase (median = 2 [range 2-4]) and during the
2-week DR-AFO phase (median = 6 [range 1-12]). Consis-
tent with findings of gait characteristics that could suggest
a more halting and unbalanced gait pattern during DR-AFO
use, 2 of 3 participants also reported a higher frequency of
falls during 2 weeks of DR-AFO use, compared with during
2 weeks of placebo use. Individual fall data are summarized
in Table 1.
DISCUSSION
In this pilot study, a small sample of boys with DMD
walked more slowly over 10 m, covered less distance in
a 6-Minute Walk Test, took longer to rise from the floor
and climb stairs, adopted a widened base of support when
ambulating, and fell more frequently when wearing DR-
AFOs. The slowed speeds when rising from the floor and
stair climbing are not surprising. Typical motor patterns
for rising from the floor and stair climbing can be impeded
by AFO wear that limits talocrural motion near neutral be-
cause additional ankle dorsiflexion and plantar flexion are
needed to move efficiently with these functional activities.
Dynamic response AFOs, which do limit talocrural mo-
tion, together with DMD-related muscle weakness, may
have conspired to make these functional activities more
challenging. Duchenne muscular dystrophy natural his-
tory studies confirm that, even without AFOs, rising from
the floor and stair climbing become increasingly difficult
for boys with DMD, particularly after the age of 7 years.6,15
In this study, the decrease in 4 stair climb speed of all 3
boys exceeded a previously identified minimal clinically
important difference (MCID) of 2.1 to 2.2 s,15 suggesting
that this loss of speed indeed represented a meaningful
decrement in performance.
Performance for primary outcomes of walking speed
over 10 m and walking endurance over 6 min also declined
with DR-AFO use. Although the slowing of 10-m walk
speed did not reach a level of clinical significance (MCID
= 1.4-2.3 s), the median decrease in 6MWD was within
the MCID range of 20 to 30 m.15 Previous studies have
established that the expected changes over time in timed

Pediatric Physical Therapy AFO Use in Boys With Duchenne Muscular Dystrophy 27
Copyright © 2015 Wolters Kluwer Health | Lippincott Williams & Wilkins and the Section on Pediatrics of the American Physical Therapy
Association. Unauthorized reproduction of this article is prohibited.
 TABLE 3
Individual and Group Median Change Gait Characteristics at a Self-Selected Walking Speed Between Baseline and Intervention With a Dynamic
Response Ankle-Foot Orthosis (DR-AFO) and Between Baseline and Intervention With a Placebo

Dynamic Response Ankle-Foot Orthosis Placebo

Participant Baseline Intervention Change Baseline Intervention Change

Velocity, cm/s
P1 70.7 92.4 +21.7 85.3 89.4 +4.1
P2 112.9 110.5 − 2.4 125.2 110.9 − 14.3
P3 116.8 112.3 − 4.5 117.2 119.9 +2.7
Median − 2.4 +2.7
Stride length, cm
P1 89.1 106.7 +17.6 112.9 104.8 − 8.1
P2 97.5 100.9 +3.4 99.9 99.3 − 0.6
P3 117.8 111.1 − 6.7 119.1 120.3 1.2
Median +3.4 − 0.6
Step width, cm
P1 9.9 10.9 +1.0 6.9 8.7 +1.8
P2 8.0 7.8 − 0.2 9.8 8.0 − 1.8
P3 12.2 14.2 +2.0 10.7 13.4 +2.7
Median +1.0 +1.8

functional test performance (eg, 10-m walk) and 6MWD
are strongly influenced by age, baseline ambulatory func-
tion, and maturational issues.14,20-22 Although improve-
ments in speed and distance with growth and develop-
ment may be seen in younger boys, progressive decline is
expected after the age of 7 years. In this study, DR-AFO use
did not improve 10-m walk speed or 6MWD in a clinically
meaningful way in any participant older or younger than
7 years of age.
Findings of a widened base of support and more fre-
quent falls with DR-AFO wear corroborate the prevail-
ing belief that bracing does not improve walking stability
in boys with DMD and may even have negative effects
on already impaired balance, an idea that has been more
theoretically than empirically based.10,23 Given underly-
ing osteopenia and increased risk of femoral and lumbar
fractures24 that can bring an end to functional ambulation,
fall prevention is an important clinical goal for boys with
DMD. More frequent falls with AFO wear implies an in-
creased risk for fall-related fractures, particularly for boys
on long-term glucocorticoid therapy.
Mean duration of wear for all 3 participants was higher
during the placebo condition than that of DR-AFO condi-
tion. Less wear of the DR-AFO could indicate lower tol-
erance for this intervention, suggesting that the placebo
was easier and more comfortable to use. On the contrary,
any beneficial effects of treatment using DR-AFOs may not
have had the same opportunity to exert themselves be-
cause the DR-AFOs were not actually used for the same
amount of time as the placebo device. It would be inter-
esting to know, for example, if the reported fall episodes
(which were more frequent with DR-AFO use) occurred
when the participants were actually wearing the AFOs or
during periods when they were not worn. This information
was solicited in parental report logs, but was not reported
in a clear enough fashion to allow analysis.
The aim of this pilot study was, in part, to assess the
feasibility of a future randomized controlled trial of AFO
effects on walking in boys with DMD. Given the small
sample size of this pilot, statistical comparison of DR-AFO
and placebo conditions was not indicated. A comparison of
data between the 2 intervention conditions showed high-
performance variability, even under baseline (no inter-
vention) conditions, suggesting the need for large sample
sizes in any future trials. Potential contributors to day-
to-day performance variability include glucocorticoid dos-
ing schedule,25 fatigue,26 and variable motivation/effort.27
Glucocorticoids (eg, prednisone or deflazacort) constitute
the only pharmacological therapy with proven potential
to decrease (temporarily) the expected decline in motor
function in boys with DMD.28,29 Although daily dosing
is common, intermittent dosing (eg, 10 days on/10 or 20
days off) has also been studied and recommended, with
the aim of achieving similar benefits to muscle and func-
tion as with daily dosing, alongside tempered negative side
effects including weight gain, stunted growth, bone loss,
irritability, and hyperactivity.3,30-32 A statistical compar-
ison of motor performance between corticosteroid “on”
and “off” times with intermittent dosing regimens could
not be found, but published data suggest that performance
on day 10 of corticosteroid dosing is consistently better
than at the end of an “off” phase.25 Therefore, intermit-
tent dosing poses an additional challenge to DMD study
design and will need to be accounted for in future trials. In
addition, future PT intervention studies should consider
differences in patterns of change over time between boys
younger than 7 years (in whom improvements in timed test
performance and 6MWD may occur) and boys 7 years and
older (in whom improved performance suggests robust in-
tervention effects)15 and recruit participants accordingly.
CONCLUSIONS
The findings from this pilot study do not suggest
clear benefits with DR-AFO use for household or commu-
nity ambulation in boys with DMD. Although individual

28 Townsend et al Pediatric Physical Therapy

Copyright © 2015 Wolters Kluwer Health | Lippincott Williams & Wilkins and the Section on Pediatrics of the American Physical Therapy
Association. Unauthorized reproduction of this article is prohibited.
 responses vary, DR-AFO wear may slow walking speed
over both short and long distances and may be associated
with instability and falls for some boys. Additional studies
of orthotic use should include a larger sample, collect more
detailed fall data, and take into account the potential effect
of corticosteroid dosing schedule.
ACKNOWLEDGMENTS
Dynamic response AFOs were provided by Allard,
USA. We thank orthotist Gordon Craig, CO, BOPCO, of
New England Orthotic & Prosthetic Systems (NEOPS) for
consultation, Brian Tseng, MD, PhD, for an introduction
to the study of Duchenne muscular dystrophy and the boys
and their families for participation in this study.
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