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Improving translation of intensity and quality of upper limb rehabilitation provided by occupational therapists to children with cerebral palsy

Improving translation of intensity and quality of upper limb rehabilitation provided by occupational therapists to children with unilateral cerebral palsy: A cluster randomised trial.

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000090415
Enrollment
76
Registered
2016-01-28
Start date
Unknown
Completion date
2017-07-30
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

Congenital hemiplegia occurs in over 1 million children under 21 years of age in the industrialized world and is the most common type of cerebral palsy. Children with unilateral cerebral palsy (CP) usually present with greater upper limb (UL) than lower limb impairment, which impacts on daily independence, societal participation and vocational aspirations. Contemporary rehabilitation approaches for which there is strong evidence (e.g. constraint induced movement therapy (CIMT), intensive bimanual training, task-oriented training) have been developed based on motor learning theory and neuroscientific research which has increased our understanding of the mechanisms of use dependent neuroplasticity. Essential elements of contemporary approaches include therapy that uses; (1) intensive structured task repetition; (2) progressive incremental challenges of increasing difficulty; (3) goal-directed framework that is self-motivating. All these components are crucial, as intensity of intervention alone, without being goal directed and structured is not efficacious. Recent surveys of paediatric therapists indicate that: (1) traditional neurodevelopmental treatment approaches remain commonly used as standard clinical practice, despite a lack of evidence of efficacy; (ii) collaborative goal setting does not often occur with patients; (iii) contemporary motor learning approaches are not often used; and (iv) objective measurement of treatment outcomes is infrequent. A tailored multi-faceted implementation strategy (using file audit and feedback, barrier identification and interactive training targeting barriers) was piloted with 9 occupational therapists from three paediatric teams and found promising changes in clinical practice behaviour including: (i) greater measurement of goals before (+17%) and after 15 (+22%) therapy; use of constraint therapy (+38%), bimanual therapy (+26%), home programs 16 (+14%); measurement of UL outcomes before (+29%) and after (+23%) therapy. Children receiving the target dose of therapy increased from 0 to 10%. A cluster randomised trial will now be conducted to compare this tailored multi-faceted implementation strategy to a single faceted strategy alone (audit and feedback). Geographical regions (n=4 regions; 36 therapists) will be randomised to receive either the multi-faceted or single faceted implementation strategy. We aim to recruit 40 children with unilateral cerebral palsy seen by participating therapists. The outcomes of the study will be assessed at the level of the therapist against 5 key evidence criteria: (1) were goals set collaboratively with patients/families; (2) were goals measured objectively before and after an episode of care; (3) was a contemporary motor learning approach used; (4) was a target dose of therapy provided (min 30 hours); (5) were upper limb outcomes measured objectively before and after a therapy episode of care. Patient outcomes include goal attainment and change in upper limb function.

Interventions

Multifaceted implementation program (MI): : (1) MI program is a multifaceted behavioural intervention and comprises (i) medical chart audit and feedback; (ii) barrier analysis and; (iii) tailored interactive training addressing barriers to implementation of contemporary rehabilitation, increasing dose and use of outcome measurement. Retrospective chart audits will be performed for all records of children with hemiplegia seen in the previous 1 year period by the chief investigator and participati

Multifaceted implementation program (MI): : (1) MI program is a multifaceted behavioural intervention and comprises (i) medical chart audit and feedback; (ii) barrier analysis and; (iii) tailored interactive training addressing barriers to implementation of contemporary rehabilitation, increasing dose and use of outcome measurement. Retrospective chart audits will be performed for all records of children with hemiplegia seen in the previous 1 year period by the chief investigator and participating occupational therapists. An audit form piloted in the TRIP project will be used to benchmark current practice against evidence criteria. Audit results for each team will be compiled by the chief investigator. Feedback of audit results will occur verbally (in a group meeting between the chief investigator and participating occupational therapists) and via written report separately to each cluster of occupational therapists. As part of the audit and feedback process, the chief investigator will lead a meeting with each cluster of occupational therapists (1-2 hours in duration) for facilitated goal setting and development of action plans to address gaps between current practice and evidence criteria identified in the file audit. Separate focus groups of approximately 1 hour duration involving each cluster of occupational therapists will be led by the chief investigator to determine unique contextual barriers to delivering the evidence-based UL intervention. Focus groups will be audiotaped, and transcribed verbatim and analysed using a framework approach (Pope et al. 2000). A validated questionnaire based on the Theoretical Domains Framework will quantitatively measure barriers to evidence based practice (Huijg et. 2014). Interactive education sessions (2 consecutive days, 4-5 hours duration each) will be conducted by the chief investigator with participating therapists in each cluster. Sessions will address knowledge and skills barriers identified during focus groups and involve small group case vignettes and problem solving. File audit and feedback will re-occur at 6 months accompanied with email project updates at 3 and 9 months to act as reminders and monitor adherence. Regular telephone and skype contact will be provided on an as needs basis determined by participating therapists. Final data collection via file audit will occur at 12 months.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Healthy volunteers
Yes

Inclusion criteria

Occupational therapists across four geographical regions, working with children with cerebral palsy will be eligible to be included. Patients: Children with unilateral cerebral palsy (aged 0-18) seen by each participating therapist will be eligible for inclusion

Exclusion criteria

Occupational therapists who have participated previously in a pilot implementation study conducted by the same research group will not be eligible for inclusion. Patients: Children with bilateral presentation of cerebral palsy are not eligible for inclusion.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026