Bobath Therapy for Children with Cerebral Palsy

• Local Health Board Public Health, Medical and Nurse Directors

CONTENTS

© 2008 National Public Health Service for Wales

Material contained in this document may be reproduced without prior permission provided it is done so accurately and is not used in a misleading context. Acknowledgement to the National Public Health Service for Wales to be stated.

Executive summary

In the United Kingdom neurodevelopmental therapy (NDT) based on Bobath principles is currently used in many settings with the intent of improving the motor and functional deficits of children and adolescents with cerebral palsy (CP).

Bobath Cymru in Cardiff provides a service to Welsh residents with cerebral palsy and from May 2007 requested an increase in funding from the local health boards. There is a perception that the service is operating without a strong evidence base compared with other conventional therapies for children with CP offered within the National Health Service, although there are acknowledged difficulties in separating out ‘standard’ and Bobath treatments outside purist settings. The aim of the present document is to report the results of a rapid review of the evidence on the clinical and cost effectiveness of NDT/Bobath therapy for children and adolescents with CP.

Themajor health care databases were searched and high level searching using meta-search engines, other databases and the websites of relevant agencies was also performed to maximise identification of literature.

The searches resulted in 350 documents for NDT/Bobath and cerebral palsy. The abstracts and titles were screened for relevance and 23articles contributed to this review. Several timely, high quality systematic reviews were identified in the scoping search and these were extensively used to inform the document.

There was good quality evidence (Levels 1 and 2) that did not provide support for the effectiveness of NDT/Bobath therapy for children and adolescents with CP.

It has been suggested that the randomised controlled trial is not an appropriate method to determine the effectiveness of NDT/Bobath therapy because of the problems of heterogeneity of the study population and the techniques used.

Published data on cost effectiveness of NDT/Bobath was not found.

Where alternative treatments are concerned, there was inconsistent evidence for the effectiveness of botulinum toxin A and speech and language therapy and further research is required. Evidence was lacking for acupuncture, rhizotomy and drug treatments and the planned Cochrane reviews on these treatments should provide further data.

1.Background

In the United Kingdom physiotherapists who treat children and adolescents with cerebral palsy (CP) generally use a form of therapy known as neurodevelopmental therapy/treatment (NDT), based on the work of the Bobaths. [1], [2] Bobath therapy aims to influence muscle tone and improve postural alignment by specific handling techniques and attempts to facilitate improved active participation and practice of relevant skills.[3]The terms Bobath therapy and NDT are frequently used interchangeably and most practising physiotherapists will adopt some Bobath handling techniques whether working within or outside Bobath settings.

The voluntary sector service to Welsh residents with cerebral palsy is provided by Bobath Cymru, based in Cardiff. Bobath has recently requested increased funding from the local health boards (LHBs) and there are commissioning concerns about this service.[4] One of these concerns is the recognition that there is not a strong evidence base for effectiveness and cost effectiveness of Bobath therapy compared with conventional treatment within the National Health Service (NHS). The National Public Health Service (NPHS) was therefore asked to investigate the evidence base for the effectiveness of Bobath therapy and alternative treatments for children and adolescents with cerebral palsy.

1. Aims

The purpose of the present document is to perform a rapid review of the evidence for the effectiveness of Bobath therapy for children and adolescents with cerebral palsy. The evidence for alternative treatments for CP was also evaluated.The paper did not seek to separately quantify or compare Bobath therapy as a wider holistic social intervention.

1. Research question

What is the evidence that Bobath therapy improves motor and functional outcomes for children and adolescents with cerebral palsy?

4.Methods

The research question in Section 3 was converted to a structured question for searching using the Population, Intervention, Comparison and Outcome (PICO)[5] format.

Patient: children and adolescents aged 0 -20[i] years with a diagnosis of cerebral palsy

Intervention: use of Bobath/NDT as a primary intervention

Comparison: alternative treatments – e.g. conventional physiotherapy/exercise training; botulinum toxin; acupuncture; surgery.

Outcome: improved motor function, improved abilities in functional skills, decrease in contractures and/or deformities

4.1Identifying existing and ongoing research

4.1i Literature searching

Systematic searching: As per the protocol contained in The evidence checklist [6] a scoping search was initially performed to identify major papers on published evidence and refine the final search strategy. For the present overview, search terms contained in the search strategies were used from published reviews and they were kept broad to maximise retrieval of references. The basic search strategy is shown in Appendix 1. The type of literature on NDT/Bobath therapy necessitated the use of a pragmatic approach to searching for evidence in order to achieve production of the review within the short timescales for delivery. It is clear that there had to be a balance between timeliness and rigour and high quality evidence and systematic reviews, meta-analyses, health technology assessments and clinical guidelines were identified first. It should be emphasised that the review is not a systematic review of primary studies.

High level searching: It is well known that the classical databases for medical literature, such as Medline, do not adequately index all relevant literature. The reviewer used validated methods that involved the use of meta-search engines and other databases for ‘high level’ searching to quickly identify relevant evidence. (Appendix 2)

For critical appraisal, the tables recommended for use in the National Institute for Health and Clinical Excellence guideline development methods manual[7] were modified to accept the type of studies identified for cerebral palsy and Bobath therapy. The quality of the evidence was graded using the NICE hierarchy of evidence and the quality checklists. Evidence was rejected if graded as poor quality, apart from where it was of Level 1 type (see Appendix 3 for explanation of evidence grading system) and was highly relevant to the questions. The data relevant to the research question was entered into an evidence table. (Appendix 4) Due to practical limitations a single reviewer performed the final selection, critical appraisal and data extraction.

Inclusion criteria

Search period January 1995 – May 2008

Papers in English, German, French or Spanish

Interventions relating to Bobath therapy in the treatment of childrenand adolescents (age range0-20 years) with cerebral palsy.

Randomised controlled trials

Systematic reviews

Meta-analyses

Guidelines

Observational studies (where higher quality evidence was not available)

5.Results

The scoping search revealed several key evidence documents and these high quality secondary sources were used to inform this paper. The searches revealed 350 documents for NDT/Bobath therapy and cerebral palsy. A total of 40 citations was downloaded into Reference Manager Software and critically appraised; 23 articles were selected to inform this review.

5.1NDT/Bobath therapy

The evidence for the effectiveness of NDT/Bobath therapy was scopedby the NPHS in 2007 and there was a lack of good quality evidence to support the effectiveness of such therapy in either stroke or cerebral palsy.[8]

A good quality (Level 2++) systematic review of studies where NDT was stated to be the primary intervention was performed by the AmericanAcademy for Cerebral Palsy and Developmental Medicine (AACPDM) in 2001 to inform an AACPDM evidence report.[9] The outcomes considered were motor responses, contractures and deformity, motor development, quantity of therapy, functional limitation/activity, and other domains of child development (cognitive, language, social, emotional etc The authors conclude that although there are still concerns regarding how to effectively measure the effectiveness of NDT in academic studies, it is time to investigate new approaches in therapy that are more effective than NDT in promoting motor and functional improvements in children with CP.A subsequent systematic review (Level 2 ++) with some methodological problems concludes that the evidence for the effectiveness of NDT in children with CP was inconclusive and inconsistent. [10]

A systematic review (Level 1+) of the effects of early intervention on motor development in children with CP or Downs syndrome was published in 2005[11] that included studies of NDT. Eight studies evaluated the effects of NDT or physiotherapy, mainly on the basis of the principles of NDT. Only one study reported a better motor outcome in the experimental group than in the controlgroup.[12] The ‘positive effect’ of this study differedfrom the other studies in being the only one that comparedintensive NDT treatment with less intensiveNDT. The other seven studies comparedNDT with infant stimulationor with a form of standardcare that was not defined further. In six of the seven studies,motor outcome in the NDT group was similar to that of the control group. In the seventh study, motor developmentwas worse in children treated in accordance with the principlesof NDT than in children who received an infant stimulationprogramme. The authors conclude that the studies indicate that NDTduring the first years of life does not have a measurable positiveeffect on motor development.

A 2007 health technology assessment {HTA}, (Level 1++) describing the results of an RCT of additional therapy for children and adolescents with CPalso summarises the existing literature on NDT/Bobath1and found that the published studies fell intothree categories:-

a)comparison of NDT with other therapeutic approaches.

The authors of the HTA conclude that there was a lack of evidence to support the efficacy of any particular physical therapy and that it was difficult to establish the advantages of one particular therapeutic method over another.

b)evaluation of the effectiveness of NDT

Conclusions from the included studies are that there was a lack of valid and objective outcome measures and power calculations. One well designed (Level 1+),but small RCT [13]demonstrated that the group that received a programme of infant stimulation followed by NDT progressed more quickly (measured using the Griffiths Development Test) than the group who received NDT alone. There were no significant differences between the groups in the incidence of contractures, or the need for orthopaedic interventions. The result emphasises the importance of measuring outcomes other than locomotion and the inputs from local services.

c)investigationof the nature and intensity of NDT

In spite of the lack of evidence for the effectiveness of NDT/Bobath, many parents and professionals believe that the therapy works for children with CP and that the more sessions the child receives the more effective is the treatment. The HTA again found that the published studies had methodological problems, particularly with sample size and power, lack of controls, sample heterogeneity, confounding and length of follow up. One RCT (Level 1- ) found no benefit of intensive NDT [14]and another RCT (Level 1 - ) found that there was a non significant trend for benefit for the intensive group when additional covariates of age and severity were introduced, not in the primary analysis and the effect was short lived.[15] Another RCT ( Level 1-) reported that the change scores for children in the intensive NDT group were higher than those of the standard group. [16]The statistical methods however, used to analyse the results of this latter trial were not appropriate. The multi-centre RCT 1( Level 1++) to evaluate the effect of increasing the frequency of NDT with blinded assessments and a cost effectiveness analysis reported in 2007 demonstrates that there was no evidence that additional physical therapy helped the motor or general development of children with CP. The authors stress that research is required into what is the optimum level of provision, since they suggest that there is a sufficiency of therapy that will be helpful and above that there is no effect. They also raise the possibility that the RCT may not be an appropriate study design when an intervention is focussed on a heterogeneous population such as children with CP.

No studies were found assessing cost effectiveness of NDT/Bobath or physiotherapy. The costs of general services for each child ranged from £250 to £6750 with higher costs associated with more severely impaired children. 1

An RCT comparing a task/content focussed treatment approach with a child focussed treatment approach for children with CP is currently being performed in North America. The rationale behind the design of this trial is the questioning of some therapists of the emphasis on obtaining ‘normality’ with the NDT approach and whether this explores all options for functional success. It may be more important to be able to perform the functional task rather than to attain normal patterns of movement. The trial is due for completion in August 2008. [17]

5.2Alternative treatments

5.2iExercise programmes

The results of a small RCT(Level 1 - ) of an exercise training program demonstrated an improvement in physical fitness, participation level, and quality of life in children with cerebral palsy when added to standard care. [18]

A good quality systematic review (Level 1 +)of all types of exercise programmes for children and adolescents with CP was published in 2008. [19]Only five RCTs investigating the efficacy of exercise training in children with CP could be included and these trials had some methodological problems. However from an evaluation of the available data it appears that children and adolescents with CP may benefit from exercise programmes that focus on lower extremity muscle strength and/or cardiovascular fitness.

5.2iiBotulinum toxin

Botulinum toxin A (BtA) injections are being used more frequently to treat upper and lower extremity spasticity and hypertonia in children with CP. Two Cochrane reviews(Level 1+) did not find sufficient evidence to support or refute the use of intramuscular injections of BtA as an adjunct to managing the upper or lower limbs in children with spastic cerebral palsy.[20][21]Further research incorporating larger sample sizes, rigorous methodology, measurement of upper limb function and functional outcomes is essential.

5.2iiiAcupuncture

Acupuncture has been used to treat children and adolescents with CP for more than 20 years. Benefits claimed for acupuncture have included warmer extremities, a decrease in painful spasms, improvement in the use of arms or legs, more restful sleep, improvement in mood and better bowel function. A Cochrane protocol aims to review all RCTs of acupuncture for children with CP. [22]

5.2ivDrug therapy

Three drugs diazepam, dantrolene and baclofen have been commonly used to alleviate spasticity in cerebral palsy; and debate remains about their usefulness and there is a Cochrane protocol to assess the absolute, and comparative, efficacy of baclofen, dantrolene and diazepam for spasticity in cerebral palsy.[23]Intrathecal baclofen, a much more invasive treatment has been recently introduced and a separate Cochrane protocol will review the evidence for the effectiveness of intrathecal baclofen. [24]

5.2vSurgery

A surgical method to reduce spasticity by selective posterior nerve root division was first described in 1913 and reintroduced in the 1970s. Numerous studies with confounding, selection bias, lack of controls and use of variable surgical techniques, and application of subjective outcome measures have reported good results leading to the widespread use of this technique.[25]The absence of good evidence to support its efficacy and the lack of information about safety and long term consequences has led to some controversy andthe role of this technique, which is expensive and very demanding of the child, family, surgeon and therapist, needs to be justified.[26] There is a Cochrane protocol designed to determine the effectiveness of selective dorsal rhizotomy in the management of children with spastic cerebral palsy. 25

5.2viSpeech and language therapy

Firm evidence of the positive effects of speech and language (SLT) for children with cerebral palsy was not demonstrated ina Cochrane review. However, positive trends in communication change were shown.[27] The authors conclude that research is needed to investigate the effectiveness of new and established interventions and their acceptability to families.