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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