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Expert Consensus on Physical Therapist Intervention after Botulinum Toxin A Injection for Children with Cerebral Palsy

Dumas, Helene M., MS, PT, PCS; O’Neil, Margaret E., PhD, PT, MPH; Fragala, Maria A., MS, PT

Clinical Report
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Purpose The purpose of this study was to gather expert consensus on physical therapist (PT) intervention after lower extremity botulinum toxin A (BtA) injection(s) for children with cerebral palsy (CP) and lower extremity spasticity. This study also examined differences in expert opinion on intervention for two groups of children with CP and differing levels of functional ability.

Methods The Guide to Physical Therapist Practice was used to develop a questionnaire. Sixty-two therapists identified as experts in the field of pediatric physical therapy rated the importance of the three PT intervention components and the seven types of direct intervention from Neuromuscular Pattern 5A for both groups. The Wilcoxon signed rank test was used to identify differences in expert responses between the groups. Experts also ranked the importance of specific intervention strategies. Consensus criteria were used to determine the importance of interventions.

Results All three intervention components and four direct interventions (Therapeutic Exercise; Functional Training-Self-Care; Functional Training-Community and Work; and Prescription of Devices/Equipment) met consensus criteria for both groups. Significant differences between groups were found for Patient/Client-Related Instruction and Direct Interventions and for Therapeutic Exercise, Functional Training in Self-Care, Functional Training-Community and Work, and Electrotherapeutic Modalities, suggesting that these items were more important for children with greater functional abilities. Twenty (35%) specific intervention strategies met consensus criteria for one or both groups.

Discussion and Conclusions All three intervention components and four direct interventions in Neuromuscular Pattern 5A are important in the PT plan of care after botulinum toxin A injection for children with CP and lower extremity spasticity. Functional ability influences therapists’ intervention choices.

The Research Center for Children with Special Health Care Needs and Physical Therapy Department, Franciscan Children’s Hospital and Rehabilitation Center (H.M.D., M.A.F.), Boston, Mass and Department of Rehabilitation Sciences, MCP Hahnemann University (M.E.O.), Philadelphia, Pa

Address correspondence to: Helene M. Dumas, The Research Center for Children with Special Health Care Needs, Franciscan Children’s Hospital and Rehabilitation Center, 30 Warren Street, Brighton, MA 02135; Email: fchcenter@tiac.net

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INTRODUCTION

Consensus exercises are often used to define levels of agreement on controversial subjects to identify solutions to existing problems in a particular field of health or medicine. 1,2 In healthcare, expert consensus methodology has been used either in conjunction with scientific evidence or independently when scientific evidence is not available. 1 Research on physical therapy practice suggests that “learning from one’s practice is a legitimate source of knowledge.”3(p31) The APTA’s Guide to Physical Therapist Practice 4 (Guide) was developed using consensus methodology. The purpose of the Guide is “to describe generally accepted physical therapist practice and to standardize terminology.”4(p1172) The preferred practice patterns in the Guide include common intervention approaches, anticipated frequency of visits, and expected duration of the episode of care for specific impairment-based diagnostic groups. 4

Consensus methodology has also been used in the development of pediatric physical therapist clinical specialization. The Pediatric Specialty Council of the American Board of Physical Therapy Specialties and the Section on Pediatrics of the APTA recently conducted a practice analysis survey of pediatric clinical specialists. This survey included items from the Guide to Physical Therapist Practice. 4 Expert consensus methodology was used to identify current pediatric practice and ensure that the pediatric clinical specialist examination is valid and reliable. Results of this survey have not been disseminated yet. 5

Research on clinical decision making for physical therapist intervention for children with cerebral palsy (CP) suggests that “the responsibility of having years of experience carries an obligation to select and apply the most effective strategies for the children under your care.”6(p167) In 1990, the Section on Pediatrics of the APTA sponsored a consensus conference to build agreement among experts in examining the efficacy of physical therapy in the management of cerebral palsy. 7 Three overall needs were highlighted to serve as a framework for future research. These needs included an update of the theoretical base for intervention for children with CP, new assessment tools, and the evaluation of intervention outcomes. 8 More than 10 years later, these needs still exist and additional studies are required to define evidence-based physical therapist intervention for children with CP.

Although consensus exercises provide valuable information, they have limitations. In this study, expert opinion was gathered using a questionnaire based on the Neuromuscular Pattern 5A in the Guide to Physical Therapist Practice 4 to determine consensus on physical therapist intervention after botulinum toxin A (BtA) injection for children with CP. Suggested approaches to improve the reliability and validity of the consensus methodology were used. These approaches included the use of a representative panel of participants; carefully defined problems and sources of data for participant use in decision making; predefined levels of agreement; and production of findings that would provide specific guidelines for future action. 2 Additionally, we anticipated that the participants, based on our definition of “experts,” would consider the scientific evidence as well as their own clinical experience related to BtA injections and physical therapist intervention for children with CP.

Cerebral palsy is a nonprogressive neurological disorder that presents with multiple impairments such as spasticity, weakness, and impaired motor control. 9 Conventional medical management of spasticity, contracture, and muscle imbalance includes stretching and splinting, physical therapy, and surgery. 10 However, current research supports the use of other medical interventions for reducing and managing spasticity in children with CP including selective dorsal rhizotomy, 11 intrathecal baclofen, 8 and BtA injections. 12,13

BtA injections are a relatively new procedure for spasticity management in children with cerebral palsy and were first documented for this purpose in 1993. 14 Research examining the effects of BtA injections on children with spasticity is limited in scope. Early studies report positive results but researchers often used measurement tools that were not standardized. 15 Studies almost exclusively document impairment level outcomes. 13,16,17 No research has been conducted on the impact of BtA injections in conjunction with physical therapist intervention or the impact of BtA injections on physical therapy service delivery. To provide safe, effective, and efficient interventions, physical therapists must be aware of the newer medical management approaches for spasticity management and their outcomes for children with CP.

Pediatric physical therapists use a variety of intervention strategies when providing services to children with cerebral palsy. Neuro-Developmental Treatment (NDT), aimed at the facilitation of normal movement patterns by the inhibition of abnormal tone and primitive reflexes, has been one of the most common interventions used by pediatric therapists when working with children with CP. 18 There is, however, little evidence that quantifies the effects of NDT. 19 In a survey of pediatric physical therapists, “fewer than half of the respondents believed that motor skills in children with cerebral palsy improve primarily through the inhibition of abnormal tone.”20(p.167) Other intervention strategies used in a physical therapy plan of care for a child with CP may include casting, strengthening, orthotic, and positioning/seating interventions. 19 Recent studies examining progressive, resistive strengthening, 21 treadmill locomotor training, 22 and electrical stimulation, 23 provide suggestions and alternatives to what may be considered traditional practice.

Pediatric physical therapists routinely provide service across the three components of intervention, 1) coordination, communication, and documentation; 2) patient/client-related instruction; and 3) direct interventions) listed in the Guide to Physical Therapist Practice. 4 In our experience, all three components of intervention are provided to children after BtA injections. Leach 24 describes five areas of physical therapist involvement when providing service to children after BtA injection: assisting in patient selection for BtA injection, assessing the child’s baseline status, goal determination, providing intervention, and performing outcome assessment.

It is important to identify effective physical therapy intervention for children with CP because they are frequent consumers of therapy, and there is little evidence to support the efficacy of these services. 19 Results of recent survey studies indicate that 87% to 90% of pediatric physical therapists reported they most commonly worked with children with cerebral palsy. 20,25 Many reports now include descriptions of outcomes for children with CP, 25 but few link these outcomes to physical therapist intervention. 26 Furthermore, as BtA injections become more common for spasticity management in children with cerebral palsy, it is anticipated that physical therapists will be providing an increasing amount of service to this population of children after injection. It is, therefore, important to describe and measure physical therapy service delivery associated with BtA injections for children with cerebral palsy to determine current practice. 27 As physical therapy goals and interventions may be revised after BtA, it is also necessary to document the influence of BtA injections on service delivery to identify proper resources, guide practice, and indicate areas of future research.

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Purpose

The purpose of this study was to gather expert consensus on physical therapist intervention after lower extremity BtA injection(s) for children with cerebral palsy and lower extremity spasticity. Secondly, this study examined whether differences exist in expert opinion regarding physical therapist intervention for two groups of children with cerebral palsy and differing levels of functional ability.

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METHODS

Participants

Sixty-two pediatric physical therapists who are considered recognized leaders in the field on the basis of their academic standing, research contribution, and/or leadership activities in APTA were selected to participate in this study. The 62 experts received a questionnaire via mail survey. The experts determined content validity by rating and ranking items. Forty-one experts returned completed questionnaires for a 68% response rate. Participating therapists were from 21 states and Canada. On average, the expert participants had 25 years of PT experience and 23 years as pediatric physical therapists. A majority (64%) of the therapists had a bachelor’s degree in physical therapy, whereas 48% also had an advanced master’s degree. Fifty-one percent of the participants had a doctoral degree in either physical therapy or a related field. Forty-eight percent of the participants held pediatric NDT certification, 17% held infant NDT certification, and 43% were certified pediatric clinical specialists (PCS). At the time of the study, 88% of the respondents reported being in clinical practice. The respondents reported spending an average of 25% of their time in patient care, 33% of their time teaching, 17% of their time in research, and 12% of their time in professional/leadership activities. All held an academic position and 95% were or had been an officer, committee chair, and/or committee member for the Section on Pediatrics of the APTA.

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Instrumentation

The authors designed the first draft of the questionnaire based on the interventions listed in the preferred practice pattern, Neuromuscular Pattern 5A, in the Guide to Physical Therapist Practice. 4 The Guide was used as a framework for the questionnaire because of the standardized terminology and because it serves as a reference for describing generally accepted practice. Neuromuscular Pattern 5A: Impaired Motor Function and Sensory Integrity Associated with Congenital or Acquired Disorders of the Central Nervous System in Infancy, Childhood, and Adolescence 4 seemed most applicable to the physical therapy needs of children with CP and lower extremity spasticity after lower extremity BtA injection(s).

The questionnaire consisted of three sections (See Appendix). Section 1 consisted of eight items to obtain demographic information about the participating experts. Section 2 included 10 items—the three components of intervention and the seven types of direct intervention identified in Neuromuscular Pattern 5A. 4 Using a five-point Likert scale, the experts rated the importance of each item for the physical therapy care of children with CP after BtA injections. The experts rated each item twice, once for each of the two groups of children with CP and differing levels of functional abilities. The experts used the same five-point scale when rating each group of children (1 = not important, 2 = somewhat important, 3 = important, 4 = very important, and 5 = extremely important).

Section 3 of the questionnaire included 57 items that corresponded with the strategies within the three components of intervention and the seven types of direct interventions identified in Neuromuscular Pattern 5A. 4 The experts ranked each strategy according to the level of importance as an intervention in a physical therapy plan of care. Experts used a three-point scale to rank the importance of the strategies (1 = most important, 2 = second most important, and 3 = third most important). The strategy items were ranked twice, once for each group of children with CP and differing level of functional abilities. The questionnaire contained requests for comments to prompt the experts to provide feedback on items. Space was provided for comments in Sections 2 and 3, and participants were directed to be item- and group-specific when offering feedback.

The two groups of children were designated as the More Mobile Group and the Less Mobile Group. Definitions were provided for each group. Group classification was based on preliminary analysis of data collected in the Spasticity Management Clinic at Franciscan Children’s Hospital and Rehabilitation Center, Boston, Mass. Findings indicated that most children receiving services through this clinic could be classified into one of two groups based on the child’s functional abilities and the goals of the BtA injection(s). The children in the More Mobile Group underwent BtA injections to improve their functional mobility skills. Children in the Less Mobile Group received BtA injections to improve ease of caregiving.

The two groups were described further based on the Gross Motor Function Classification System for Cerebral Palsy (GMFCS). 28 Children in the More Mobile Group had limitations in functional mobility but were independent in one or more areas of self-mobility including rolling, sitting, crawling, walking, or powered mobility. These children were similar to children classified as levels I to IV of the GMFCS. 28 The children in the Less Mobile Group had physical impairments that limited voluntary control of movement. Also, self-mobility was limited severely for children in the Less Mobile Group even with the use of assistive technology. These children would be placed into level V of the GMFCS. 28

The initial questionnaire underwent critical review by two experts in pediatric physical therapy who did not participate in the survey. Revisions were recommended to clarify survey instructions, group definitions and formatting, and minor revisions were recommended in item content. Revisions were completed in the summer of 1999. No formal pretesting of the questionnaire was performed because the content of the questionnaire was based on the Guide, 4 a previously validated consensus document.

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Procedure

In July 1999, questionnaires (Appendix) were mailed to the 62 experts with a cover letter explaining the purpose of the study and a self-addressed, stamped envelope with a two-week return request. A 45% response rate was achieved after the first mailing. Reminder cards were sent to nonrespondents in September 1999, and a second mailing was conducted in October 1999. The cutoff date for receiving returned questionnaires was mid-November 1999. A final response rate of 68% was achieved.

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Data Analysis

Ratings of intervention components and types of direct interventions.

All responses were coded and entered into the database program, Statistical Package for the Social Sciences (SPSS 9.0). 29 Frequencies were calculated on expert ratings of each of the three components of intervention and the seven types of direct intervention in Neuromuscular Pattern 5A. 4 Responses were recoded from the five-point rating scale to a three-point scale (1 = not important, 2 = important, 3 = very important) to aggregate data appropriately for comparisons using the nonparametric Wilcoxon signed rank test. This test was used to identify statistically significant differences between experts’ ratings for children in the More Mobile Group and the Less Mobile Group on the importance of components of intervention and/or types of direct interventions.

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Rankings of intervention strategies.

Frequencies of experts’ rankings of strategies within the components of intervention and within the types of direct intervention were generated. Frequencies of ranking are presented as the sum of all three rankings (1st most important; 2nd most important; and 3rd most important) on an item in proportion to the total number of participants. It was decided that aggregating frequencies of ranked responses across levels of importance would be more meaningful (and more likely to reach consensus) than frequencies reported for individual levels of importance. For example, within the Coordination, Communication, and Documentation Component of Direct Intervention, 31 experts ranked communication as 1st, 2nd, or 3rd most important. Therefore, 31 (75%) experts indicated that communication was an important intervention strategy.

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Consensus criteria.

Consensus criteria were defined based on previous studies. 1 These included: a) 75% expert consensus on items rated as important, very important, or extremely important for both groups on the three components of intervention and seven types of direct intervention; and b) 50% consensus on strategies within the components and types of intervention ranked as important for both groups. The consensus criteria for ranked strategies was lowered from 75% to 50% because fewer strategies reached higher levels of consensus given the number of strategies being ranked (57) and the number of respondents (41).

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RESULTS

Ratings of Intervention Components and Types of Direct Intervention

Frequency distributions for the experts’ ratings of the three components of intervention indicated that 90% to 100% of respondents rated these components as important, very important, or extremely important for physical therapist intervention after BtA injections. Only four of the seven types of direct intervention met consensus criteria: 1) Therapeutic Exercise; 2) Functional Training in Self-Care and Home Management; 3) Functional Training in Community and Work Integration and Reintegration; and 4) Prescription, Application, and as appropriate, Fabrication of Devices and Equipment (Table 1).

Table 1

Table 1

The Wilcoxon signed rank test was used to determine significant differences between the More Mobile Group and the Less Mobile Group in the experts’ ratings of intervention components and types of direct intervention. In the experts’ ratings of importance for the three components of intervention for the two groups, statistically significant differences (p < 0.05) were found for Patient/Client-Related Instruction and Direct Interventions suggesting that these components were more important for children in the More Mobile Group than for those in the Less Mobile Group. Statistically significant differences were also found for the following types of direct intervention: Therapeutic Exercise, Functional Training in Self-Care and Home Management, Functional Training in Community and Work Integration and Reintegration, and Electrotherapeutic Modalities, indicating that experts considered these direct interventions more important for children in the More Mobile Group than the Less Mobile Group.

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Rankings of Intervention Strategies

Seventeen of the 32 (53%) intervention strategies that reached consensus in ranking the importance of strategies were from the components and types of direct intervention that reached consensus on rating importance of components and types of intervention. Several other strategies that reached consensus in ranking the importance of strategies were from two types of direct intervention that did not reach consensus on rating the importance of interventions. Soft tissue mobilization reached consensus for importance of strategies, although Manual Therapy did not reach consensus on rating the importance of types of direct interventions. Electrotherapeutic Modalities also did not reach consensus on rating the importance of types of direct interventions but two strategies listed in this intervention did: biofeedback and neuromuscular electrical stimulation. Including these three strategies (soft tissue mobilization, biofeedback, and neuromuscular electrical stimulation), 20 (35%) strategies from the total 57 intervention strategies listed in Neuromuscular Pattern 5A 4 were considered important by these experts (Table 2).

Table 2

Table 2

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DISCUSSION

Ratings of Intervention Components and Types of Direct Intervention

Expert consensus indicates that all three components of intervention (Coordination, Communication, and Documentation; Patient/Client-Related Instruction; and Direct Interventions) are important for children with cerebral palsy and lower extremity spasticity following lower extremity BtA injection. These findings provide preliminary support of the clinical application of intervention components in the Guide to Physical Therapist Practice. 4 Results also indicate that only four of the seven types of direct interventions from Neuromuscular Pattern 5A 4 are important in a physical therapy plan of care for this patient population: Therapeutic Exercise; Functional Training in Self-Care and Home Management; Functional Training in Community and Work Integration or Reintegration; and Prescription, Application, and as appropriate, Fabrication of Devices and Equipment. These findings suggest that therapists should carefully choose direct interventions to meet the individual needs of the child. The Guide 4 should be used as a framework when designing a plan of care. Furthermore, based on experts’ comments, refinements of practice patterns are warranted to clarify language and remove ambiguity and redundancy among types of intervention.

Results also indicated that experts rated two components of intervention and four types of direct intervention differently for the More Mobile Group and the Less Mobile Group. Experts felt it was more important to provide patient/client-related instruction and direct intervention to children in the More Mobile Group than to those in the Less Mobile Group. These results suggest that children with greater functional abilities may benefit more from these components of intervention. A reason for the group difference may be that these two components of intervention incorporate more functional and “interactive” strategies, whereas coordination, communication, and documentation is more focused on information exchange and case management, important components for both groups of children. The four types of direct intervention that resulted in significantly different experts’ ratings of importance were also more functionally oriented suggesting that experts considered these types of intervention more appropriate for children with more functional potential (More Mobile Group). Those interventions that were rated as equally important for both groups had a strong focus on reducing impairments and providing external or structural support (manual therapy; devices/equipment; electrotherapeutic modalities). Differences between groups in importance of components and types of intervention further indicate that physical therapy plans of care must be individualized considering the child’s functional ability and anticipated outcomes.

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Rankings of Intervention Strategies

In addition to the 20 strategies that reached consensus on ranking importance, the authors felt that the strengthening and stretching strategies in Therapeutic Exercise were important strategies for this patient population, although they did not reach the consensus criterion defined for this study. In addition, documentation, a strategy within the Coordination, Communication and Documentation component of intervention, was considered important by the authors, although consensus criterion was not achieved.

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Consensus Criteria

Suggestions to improve reliability and validity of consensus data include carefully defined problems and sources of data for participant use in decision making. 2 Comments from the expert participants in this study reflect limitations in these areas. Experts indicated that more information was needed about each of the two groups of children (ie, goals of physical therapist intervention) to better determine the importance of types of intervention and intervention strategies. Experts also commented that additional descriptive information about the children (ie, cognitive level and age) would have assisted them in their response ratings. Other comments from the experts included suggestions to provide definitions of intervention components, types, and strategies. Experts indicated that some types of interventions and strategies were redundant. Future revisions to the questionnaire should incorporate expert comments by modifying intervention items to be more specific to the patient population being studied. The experts also expressed concern about the limited number of choices (one or two choices) for ranking on a three-point scale in the Physical Agents and Mechanical Modalities and Electrotherapeutic Modalities Intervention sections.

Fink et al 1 and Boyce et al 2 advocate the dissemination of consensus data to the appropriate audiences and most importantly to the participants. This study is intended to provide initial information for pediatric physical therapists on interventions used for children with cerebral palsy. However, since BtA injections are a relatively new medical procedure, therapists are encouraged to continue to assess the influence of BtA injections on their intervention on an ongoing basis. Also, as indicated by comments of the experts, interventions are chosen based on individual characteristics of a child and family. The interventions in Neuromuscular Pattern 5A of the Guide 4 provide only a general outline for this process.

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CONCLUSIONS

BtA injections are being used with increasing frequency for children with cerebral palsy and there is increasing evidence to support its effectiveness in the management of spasticity. 10,13,16 Physical therapists commonly provide intervention for children with cerebral palsy who have received BtA injections. However, there have been no studies of physical therapist intervention in combination with BtA injections and no studies of the influence of BtA injections on the physical therapy plan of care for children with cerebral palsy and lower extremity spasticity.

The expert therapists in this study agreed that all three components of physical therapist intervention and four of the seven direct interventions in preferred practice pattern Neuromuscular Pattern 5A from the Guide to Physical Therapist Practice 4 are important for children with cerebral palsy and lower extremity spasticity after BtA injection(s). The experts also agreed that the importance of the interventions differ for children with different functional abilities. Furthermore, consensus was achieved on only 35% of the intervention strategies from the three components of intervention and the seven types of direct interventions for one or both groups.

It is important for physical therapists to document interventions for specific diagnostic groups. Describing interventions is an initial step in linking intervention to outcome. In this study, expert consensus was reported for physical therapist intervention after lower extremity BtA injection(s) for two groups of children with cerebral palsy and lower extremity spasticity. Future studies should examine specific physical therapist interventions in conjunction with BtA injections and the use of appropriate measures to document changes at all outcome levels. Also, in the future researchers should consider including components of other practice patterns for intervention items that might be used in physical therapist practice after BtA injection(s) for children with cerebral palsy and lower extremity spasticity.

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ACKNOWLEDGMENTS

The authors would like to thank the expert therapists who participated in this study. The authors would also like to thank Drs. Robert Palisano and Stephen Haley for their guidance and feedback throughout this study. The authors would also like to thank Margaret Renn, a student at Boston University, for assistance with data management and manuscript preparation.

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APPENDIX

Neuromuscular Pattern A: Interventions for Children with Spasticity Status Post-Lower Extremity Botulinum Toxin A Injection

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APPENDIX—continued

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APPENDIX—continued

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APPENDIX—continued

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Keywords:

physical therapy; cerebral palsy/drug therapy; decision making; professional practice

Copyright © 2001 Academy of Pediatric Physical Therapy of the American Physical Therapy Association