Ataxia Clinical Trial
Official title:
The ASsessment and Physiotherapy managEment of Ataxia in Children Following Surgical Resection of Posterior Fossa Tumour (ASPECT)
The overall aim of the study is to determine the feasibility of conducting a randomised controlled trial (RCT) studying the effectiveness of physiotherapy intervention (virtual training) in children with ataxia following surgical resection of posterior fossa tumour
Brain tumours are the most common group of solid tumours in children accounting for nearly a
quarter of all childhood cancers. There are approximately 500 new cases of central nervous
system (CNS) tumours in children/adolescents reported in the UK per year. Although prognosis
has improved over the last 30 years, brain tumours remain the leading cause of
tumour-associated death in children. Surgical resection is a mainstay of management of
children with brain tumours, as for several tumour types there is strong evidence that
survival and progression free survival are influenced by the degree of resection. Therefore
extensive tumour removal is an operative goal, but the morbidity of surgery along with any
subsequent oncological treatment should also be considered. The NICE guidelines for improving
outcomes in children and young people with cancer identify that 'Survivors of CNS malignancy
are among the neediest of all cancer survivors, because of the effects of the tumour and
multimodality therapy, all of which affect neurological, psychological, endocrine and
academic function and become more evident with increasing age'.
Children with posterior fossa tumours (PFT), which account for approximately 50% of all
childhood brain tumours, have a distinctive set of issues e.g. potential for gross change
pre/post operatively, rapid onset of ataxia, hydrocephalus and increased intra-cranial
pressure adding deficits distinct from ataxia, in addition to potential problems from any
subsequent oncological management such as radiotherapy. Of these issues, ataxia is the
predominant motor problem in children with posterior fossa tumours. Ataxia can describe a
related number of impairments including upper limb control, balance, gait difficulties, eye
movement issues and speech problems. It is a presenting sign in 58-90% of children with
posterior fossa tumours. Ataxia and balance problems also persist long term following
surgery, Piscione et al found 70% of children with posterior fossa tumours will have long
term post-operative balance problems. Lannering et al specified that truncal ataxia was the
most disabling motor impairment in children with brain tumours.
Access to neuro-rehabilitation is recognized as crucial in paediatric neuro-oncology with
physiotherapy integral to this; yet there is no consensus as to the type, intensity or timing
of interventions. A literature review of physical therapy/physiotherapy for children with
ataxia (of any origin) was carried out in preparation for this project to confirm the
literature gap, and consider interventions that have been of value in other pathologies
causing ataxia. Ten papers in total were identified which included three review papers that
covered adult and paediatric literature though the data were not separated in the studies to
enable consideration of paediatrics as a distinct group. Overall the reviews concurred there
was a suggestion of the benefit of physiotherapy (including treadmill training,
rehabilitation, virtual training) though treatment modalities were often not consistently
defined and evidence was typically of low quality (level III/IV). The recommendations from
these reviews are that the next step would be to undertake RCTs (randomised controlled
trials) in more homogenous patient groups. Looking at the paediatric literature, there were
three case studies identified (and one case series with a population of three adolescents)
again in differing diagnoses though none were examining children with brain tumours that is
the most common acute cause for ataxia in the paediatric population. The largest paediatric
study (n=10) identified through the literature review was a cohort study by Ilg et al
evaluating the effect of virtual training. Virtual training refers to the use of computer
technologies that provide an interactive environment that requires limb movement to react to
on screen game play. Ilgs study found positive results and proposed that virtual training
should then complement/supplement therapy treatment tailored according to the individual and
continued in the home environment. Virtual training has also been explored in other
paediatric populations e.g. cerebral palsy.
Overall the literature review highlighted that there is a gap in the literature regarding
physiotherapy intervention for children with ataxia, in particular there is no literature on
effectiveness of physiotherapy for children with brain tumours. However, there is an emerging
evidence base in adults with ataxia and to a lesser extent paediatric populations as
described above, from similar (though non acute) lesions in the cerebellum reporting the
benefits of balance therapies including virtual training. This suggests the potential for
recovery from ataxia in similar conditions i.e. children with damage to the cerebellum
following surgical resection of posterior fossa tumour.
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