Intrathecal baclofen therapy for management of spasticity: An Australian paediatric multicentre prospective audit.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12610000323022

Enrollment

100

Registered

2010-04-21

Start date

2010-04-26

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Intrathecal baclofen (ITB) therapy is used to manage severe spasticity. ITB therapy is available to children and adolescents at 6 tertiary Paediatric hospitals in Australia. ITB is a new therapy, with 12-15 ITB pumps implanted in Australian children and adolescents each year. There is no standard pre assessment tool or follow up protocol for children and adolescents receiving ITB therapy in Australia. The objective of this study is to identify and collect a minimum data set for assessment and follow up of children and adolescents receiving ITB therapy in Australia. Two of the aims of this study are (1) Identifying which assessment tools are useful at assessing the effect of ITB upon your child’s daily functioning; and, (2) document the complications associated with ITB therapy. For the purposes of data collection a prospective multicentre audit is proposed. This would include children attending Princess Margaret Hospital for Children (Perth), Royal Childrens Hospital (Melbourne), Monash Medical Centre (Melbourne), Westmead Childrens Hospital (Sydney), Women & Childrens Hospital (Adelaide) and the Royal Childrens Hospital (Brisbane). All Australian children and adolescents who are offered ITB therapy will be asked to enrol in this audit. A standardised assessment protocol will be utilised by each centre to capture data across each domain of the World Health Organsiation international classification of functioning, disability and health. Participation in this prospective audit reflects standard care and is voluntary.

Interventions

Enrolment in this paediatric long term outcome audit will be offered to new patients offered ITB therapy. We are collecting a minimum data set for children and teenagers receiving intrathecal baclofen (ITB) therapy in Australia. We have applied The International Classification of Functioning, Disability and Health (ICF) model to assess the impact of ITB therapy upon participants. The main domains of the ICF are: 1. Body Functions - physiological functions of body systems. 2. Body Structures - anatomical parts of the body such as organs, limbs and their components. 3. Activity is the execution of a task or action by an individual. 4. Participation is involvement in a life situation. During the assessment phase individual therapy goals are set. The Canadian Occupational Measure (COPM) can be used to set the therapy goals and the Goal Attainment Scale (GAS). Several outcome measures are being used to assess change in the ICF domains described above. These are fully discussed in the Outcomes section of this document. On average 12 ITB pumps are implanted each year in Australian children. Therefore data, will be collected for 10 years.

Eligibility

Sex/Gender

All

Age

0 to 18 Years

Healthy volunteers

Inclusion criteria

Enrolment in this paediatric long term outcome audit will be offered to new patients offered ITB therapy. The decision whom is offered ITB therapy in Western Australia rests with Movement Disorder’s team at Princess Margaret Hospital. This decision is made following a multidisciplinary medical assessment process including a test dose of intrathecal baclofen. Hospitals providing paediatric ITB programmes in Australia include Princess Margaret Hospital for Children (Perth), Royal Childrens Hospital (Melbourne), Monash Medical Centre (Melbourne), Westmead Childrens Hospital (Sydney), Women & Childrens Hospital (Adelaide) and the Royal Childrens Hospital (Brisbane).

Exclusion criteria

There are no specific exclusion criteria.

Outcome results