Randomised Controlled Trial to Compare Two Methods of Constraint Induced Movement Therapy to Improve Functional Ability in the Affected Upper Limb in Pre-school Children With Hemiplegic Cerebral Palsy

Cerebral Palsy(CP) is the most common lifelong neurodisability with a prevalence of approximately 2 per 1000 children born in Europe. Hemiplegic cerebral palsy (HCP) is characterised by unilateral motor impairment and is present in around 30% of all CP in the UK. The associated impairments of the arm and hand can cause lifelong major difficulties with manual dexterity and upper limb functional ability and independence. Elective non-use may add substantially to the problem as children may disregard their affected hand even when the actual motor loss is mild.

This may lead to further impairment including increased muscle tone, reduced ranges of movement, weakness and delayed skeletal maturity.Physiotherapists and occupational therapists are routinely involved in the care of children with CP. They employ a number of strategies in upper limb rehabilitation. However, the lack of randomised controlled trials (RCTs) has meant that the effects of different upper limb treatments are not well understood. Also the efficacy of therapy has been questioned.

Constraint induced movement therapy (CIMT) has its origins in behavioral research with primates conducted by Taub in the 1980s. It consists of the immobilisation of the unaffected upper limb, together with massed practice of the affected upper limb. It has been extensively tested with adults poststroke and has been found to be effective in improving patient centered and motor outcomes with improvement maintained for 24 months. A Cochrane review of CIMT in children with HCP(2007) with 2 RCTs (n=49) and a case control study found that the evidence for the use of CIMT was promising but that there was a need for further evidence to support its use in practice.Additionally, Huang(2009)carried out a systematic review of 21 intervention studies of which 5 were RCTs (n=114) on the use of CIMT in children with HCP and found positive support for it although there were recommendations for further research to provide information about the threshold of effective intensity and comparisons of different components in relation to specific children. The McMaster Centre for Child Disability Research describe the evidence for the use of CIMT with HCP as promising and rate it as an 'A' although recommend that investigation is required to continue to evaluate its effectiveness and address ongoing questions. The aim of this study is to compare the use of CIMT in the preschool child in an NHS setting, using prolonged restraint (splint/cast with a bandage to enclose the fingers) with using brief manual restraint which may be used in current practice and acts as the control arm.

The research proposal has been developed not only with scientific critique but also from input at all levels from service users (parents) whose children have already been involved with CIMT especially one who was the subject of a single case study carried out by the author. Design: A pragmatic, multicentered, blinded, individually randomised controlled trial. Baseline Assessment Three baseline assessments will be conducted prior to randomisation. The Assisting Hand Assessment (AHA),developed for children aged 18 months to 5 years which is a well evaluated measure appropriate for hand function in hemiplegia will be carried out by the chief investigator (CI). The AHA is administered in 2 steps. Firstly a DVD is made of a 1015 minute semistructured play session with the child using toys from the AHA kit which require bimanual activity. Using the DVD,the play session is then scored by a validated AHA scorer. The CI will carry out all of the recorded play sessions and will do some of the scoring along with another AHA validated scorer who is a therapist who works for another NHS trust. The CI will also assess the patient's affected upper limb using the Quality Of Upper Extremity Skills Test (QUEST) which evaluates four domains: dissociated movement, grasp, protective extension, and weight bearing. This will provide evaluation of the severity of the underlying impairment and allow comparison with other studies.

Parents/guardians will complete the PedsQL Generic Core Scales and the Cerebral palsy Module to assess the impact on quality of life. Randomisation will then be carried out using a standard method with adequate concealment.