The Development of an Orthotic Management Protocol for Preambulatory Children with Spastic Diplegic Cerebral Palsy
Donald Weber
ABSTRACT
The Lower-Extremity Orthosis (LEO)
study (Evans, Gowland, et at.) is a randomized controlled trial assessing the
efficacy of ankle-foot orthoses (AFOs)
in treating preambulatory children with
spastic diplegic cerebral palsy. The
range of neuromuscular and skeletal
presentations manifested by the cerebral
palsy child created a challenge when attempting to standardize the orthotic prescription criteria and orthotic design for
the study. The study was more difficult
because of the differing approaches to
cerebral palsy management and the variety of orthosis designs available.
Consensus techniques were used to
develop the standardized orthotic management protocol for the LEO study.
Consensus methods have been used to
define levels of agreement on controversial medical problems (1-3). A combination of the Delphi and Nominal
Groups consensus methods was used to
develop the orthotic management protocol for the LEO study. Current orthotic
management techniques were collected
through a survey sent to orthotists and
therapists (CP Orthotic Management
Survey), and this information was used
to draft the protocol. Therapists, orthotists and researchers involved in the
LEO study revised the draft. This article documents the development method
of the orthotic management protocol as
applied to orthotic management problems.
The Orthotic Management Survey
The orthotic management survey collected a comprehensive, broad-based
listing of prescription criteria and production procedures for AFOs used in
orthotic management of cerebral palsy
children. This information formed the
first draft of the orthotic management
protocol for the LEO study.
Since the scope of this survey extended across Canada and the United
States, a mail survey was used to minimize administrative costs. The length
of the survey and the time required to
complete it precluded the use of telephone interviews.
To establish the current practice of
orthotic management for cerebral palsy children, the survey was sent to qualified orthotists or physical/occupational therapists. Practitioners were directly involved in the orthotic and/or therapeutic management of spastic diplegic
cerebral palsy children or involved in
teaching these techniques to orthotists
and/or therapists. Survey participants
included professionals from dispersed
geographical locations in North America.
A Medline search located authors of
recent research articles related to the
orthotic management of cerebral palsy
children. Authors were selected if their
current research was applicable to the
study.
Experts also were located through
word-of-mouth. Therapists qualified to
complete the survey were asked if they
worked closely with physical therapists
or orthotists in the management of cerebral palsy. If they answered "yes,"
then both the orthotist and the therapist were asked to fill out the survey
either together or individually. Those
not qualified to fill out the survey were
asked to suggest someone in their geographical area who might be. All experts were asked to suggest names of
professionals outside their area who
might also be appropriate.
Survey Content and Design
The orthotic management survey was
divided into two parts. Part I, patient
assessment, investigated the criteria
used to assess the cerebral palsy children (neuromusculoskeletal and gait
characteristics). The inclusion/exclusion criteria for children entering the
LEO study were documented at the beginning of the survey to define the type
of patient the survey respondents
should consider (see Table 1
). Patient
assessment criteria were listed under
four sections: joint range of motion,
bony and/or ligamentous deformity,
neural control and pathological gait.
Each of these sections listed criteria
commonly used to assess patients for
orthoses. Respondents were asked to
add any criteria they felt were missing.
Each criterion was then rated according to the following scale:
3 = essential (assessed on all patients-essential for the orthotic prescription)
2 = important (assessed on most patients but of less importance to the orthotic prescription)
1 = minimal importance (assessed
on some patients but usually of minimal importance to the orthotic prescription)
0 = never assessed (not useful for
the orthotic prescription)
To aid respondents, an example
showed the hypothetical completion of
a short section of the survey (see Figure
1
).
Part II, AFO production methods,
was designed to collect information on
the different methods used in producing AFOs for children with cerebral
palsy. The sections were casting the
negative, cast modifications, fabrication, fitting and follow-up.
In each section procedures and/or
component parts that might be used to
produce AFOs were listed. Survey respondents were asked to complete the
following steps:
- Designate if you use the procedure
and/or component part.
- Add any procedures you use that
are not shown.
- Give rationale for any differences
and/or unique features of your fabrication technique in the comment area
provided.
Question and Rating Scale Design
To create a logical flow of ideas, survey
questions were ordered to reflect the
way patients proceed through a clinical
setting from assessment to casting, fabrication and fitting. The use of semiclosed questions ensured a certain level
of response but did not restrict and possibly bias the responses (4). The open-ended part allowed respondents to give
information on approaches not listed in
the survey. Since the survey objective
was to obtain a broad-based sample of
current orthotic practice, semi-closed
questions maximized information obtained from respondents.
The four-point rating scale (Part I)
forced respondents to evaluate the criteria (5). With an even number of
points on the scale, respondents rated a
criterion as either valuable (2 or 3) or
of little value (0 or 1). Rating a criterion as a 2 versus a 3 allowed respondents to identify the most important
criteria among those considered valuable. Space was provided (in chart
form) at the end of each section of Part
I to allow respondents to describe how
assessment criteria rated as valuable (2
or 3) would result in changes to the
design and/or prescription of the orthosis.
Since the survey was sent to health
professionals from a broad geographic
base, attention was given to question
wording. Concise and consistent language with common terminology was
used. Reference articles (6-10) were
sent with each survey package to illustrate techniques and standardize biomechanical and medical terminology.
Survey Development and
Implementation
The author developed the survey from
standard texts on patient assessment
and long-term experience in the orthotic management of cerebral palsy
children (see Figure 2
). This draft was
then critiqued by members of the LEO
research group (a pediatrician, a research methodologist and two physical
therapists) and two certified orthotists,
who evaluated it for content, design
methodology and readability.
A second draft was then pretested by
one orthotist and one therapist in each
of the six hospitals participating in the
multi-center trial. Information from
the surveys was collated and analyzed.
Additional information regarding survey content and format was received at
a one-day meeting with the orthotists
participating in the study.
Feedback resulted in a few minor
changes and produced the third draft,
which was then sent to the experts. Results were collected, collated and used
to produce the first draft of the orthotic
management protocol.
The two-part survey was very detailed-partially open-ended questions
demanded substantial effort and time
to complete. To increase the response
rate, most respondents were contacted
by telephone or visited in advance and
apprised of the objectives, content and
time needed for the survey. Those not
contacted personally were sent a note
explaining the survey. To increase the
response rate, a second telephone contact was made to all those who did not
return the surveys by the deadline. The
initial response rate of 48 percent (19/
40) was increased by 25 percent (29/40)
with this second contact.
Orthotics Management Consensus
Meeting
The second stage of the consensus exercise was designed to develop the final
draft of the standardized orthotic management protocol outlining the prescription criteria and production protocol for the AFOs to be used in the LEO
study. The 25 participants in the consensus meeting included orthotists and
therapists from the six geographic areas participating in the LEO study,
outside experts in orthotic management of cerebral palsy and members of
the LEO study research group. Only
the 18 participants directly involved in
the orthotic management of cerebral
palsy were allowed a vote during the
consensus process.
Consensus Development Procedures
All participants received the first draft
of the orthotic management protocol
to review and critique before the consensus meeting. During the first part of
the meeting, participants were introduced and data collecting and processing methods used to produce the first
draft were reviewed. The remainder of
the meeting was spent developing the
document.
The first draft of the orthotic management protocol was divided into
small logical topic areas of similar content. Consensus was developed in each
of these topic areas through these
steps:
- A brief review of the topic, including the proposed protocol and a rationale for the statement based on the information collected from the orthotic
management survey.
- Critique by an internationally respected expert in cerebral palsy management.
- Discussion, clarification and revision of the first draft of the consensus
document under the supervision of a
consensus facilitator.
- A vote to accept or reject the topic
of the orthotic management protocol.
If a two-thirds majority of meeting
participants accepted the protocol topic after discussion and revision, the
topic became part of the final draft of
the orthotic management protocol. If a
two-thirds majority vote was not
achieved, the topic went back to the
group for discussion and revision. If
consensus on the topic was not deemed
possible by the facilitator, differences
were recorded in the final document.
Results
The survey/consensus process produced
the final version of the orthotic management protocol as outlined in Appendix I
.
Used to decide which of the orthotic de
sign features is most appropriate to each
child, the orthotic management protocol
formed a comprehensive framework for
a standardized approach to the orthotic
management of the cerebral palsy children enrolled in the LEO study. The
inclusion of experts from across North
America ensured that the orthotic prescription criteria and production techniques in the protocol were consistent
with current practice.
Through scientifically rigorous consensus meethods involving expert orthotists and therapists, agreement was
reached about a number of conceptual,
structural and functional issues regarding the prescription and fabrication of
AFOs. Standardization of this AFO
will enable investigators to be sure they
are studying the effects of a "standardized" orthosis (see Figure 3
).
Acknowledgments
A special thanks to all participants and organizers who made this consensus session a
success and to the Neurodevelopmental
Clinical Research Unit (NCR U) for its financial support.
DONALD WEBER is a certified orthotist (Canada) in the Orthotics/Prosthetics Departmetn at Chedoke-McMaster Hospitals in Hamilton, Ontario and an orthotics instructor for the clinical O&P program at George Brown College in Toronto. He is a Fellow of the Canadian Board for Certification (FCBC)
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