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Preschool HABIT-ILE: A randomised controlled trial to determine efficacy of intensive rehabilitation compared to usual care to improve motor skills of children, aged 2 to 5 years, with bilateral cerebral palsy.

Preschool HABIT-ILE: A randomised controlled trial to determine efficacy of intensive rehabilitation compared to usual care to improve motor skills of children, aged 2 to 5 years, with bilateral cerebral palsy.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000071921
Acronym
Preschool HABIT-ILE
Enrollment
28
Registered
2020-01-29
Start date
2021-01-01
Completion date
2024-05-01
Last updated
2026-06-15

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

Conditions

None listed

Brief summary

In Australia, 35,000 people have cerebral palsy (CP), and between 60-70% of these have difficulties with movement on both sides of their body. There are currently no effective interventions for children with CP that affects both sides of their body to improve their ability to use their hands, walk and perform daily life tasks. We will test the efficacy of Hand Arm Bimanual Intensive Training Including Lower Extremity (HABIT-ILE), in pre-school aged children with cerebral palsy and compare results to usual care.

Interventions

HABIT-ILE is a motor learning approach simultaneously addressing coordination of the upper and lower limbs. Key elements of HABIT-ILE are: Dose: 30 hours of therapy achieved through a 2-week intensive group-delivered model for 3 hrs/day over 10 days in addition to a home program for generalization of learning. Home program dose will aim to achieve a further 10 hours over the two week intervention period for a total dose of preschool HABIT-ILE of 40 hours. Mode: Groups of 4-6 children (1:1 or 2

HABIT-ILE is a motor learning approach simultaneously addressing coordination of the upper and lower limbs. Key elements of HABIT-ILE are: Dose: 30 hours of therapy achieved through a 2-week intensive group-delivered model for 3 hrs/day over 10 days in addition to a home program for generalization of learning. Home program dose will aim to achieve a further 10 hours over the two week intervention period for a total dose of preschool HABIT-ILE of 40 hours. Mode: Groups of 4-6 children (1:1 or 2:1 therapist:child ratio according to ability). Content and tailoring: The intervention will be based on the child’s motor abilities (determined at baseline), age, interests and caregiver-identified functional goals. Tasks/activities are made incrementally more challenging. Practice will be embedded in play, using part and whole task practice with high repetition including (i) table top fine motor play-based activities; (ii) activities of daily living when sitting/standing/walking; and (iii) gross motor play. Lower extremity motor abilities and postural control will be progressed from lying to sitting on the floor and then to a small bench, and transitions between floor to sitting, sitting to standing. Intervention providers: Physiotherapists and occupational therapists, who have completed standardized training and are experienced in delivering HABIT-ILE with older children. A speech pathologist will consult with the team if children have specific communication (receptive and/or expressive) or feeding difficulties. The level of intensity (e.g. low, moderate, vigorous) and how this is assessed: Low to vigorous. Will vary across the intervention session. Children will be wearing polar heart rate monitors during the intervention sessions. Strategies used to assess or monitor participant adherence to the intervention, (e.g. session attendance checklists, diary, etc) : Daily sign on/off sheets for caregivers, daily activity log detailing activities throughout course of session completed by one of treating therapists. For 30 minutes, at the conclusion of each session, the child’s treating therapists will meet individually with the child’s caregiver/s (one-on one) and discuss the daily program and make suggestions about activities that could be practised at home. These will be detailed on a written home program form and will include a home practice log completed by the caregiver. The home program activities will be reviewed daily by the child’s treating therapist in collaboration with the child’s caregiver and updated as appropriate. Parents will be able to take short videos/photos of home practice activities on their smart phone if they wish so to have a visual reminder to take home. Location: Centre for Children’s Health Research and QCH, South Brisbane. Fidelity: Standardised therapist training will be provided to therapists employed to deliver the intervention. The training package will include an intervention manual and onsite training during the first Preschool HABIT-ILE camp lead by a master trainer Location: Centre for Children’s Health Research and QCH, South Brisbane.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
2 Years to 5 Years
Healthy volunteers
No

Inclusion criteria

Key inclusion criteria: (a) diagnosed with bilateral CP (diplegia/quadriplegia), GMFCS levels II (walks with limitations) to IV (limited self-mobility but able to do a standing transfer with the assistance of 1 person); (b) aged 2 to 5 years, 5 months at study entry (c) ability to grasp light objects and lift more impaired arm 15cm above a table surface; (d) able to understand instructions and complete testing.

Exclusion criteria

Key exclusion criteria: (a) uncontrolled seizures (b) orthopaedic or neurological surgery in the six months prior to or scheduled during study period (eligible for inclusion if at least 12 months orthopaedic or neurological surgery) (c) visual impairment interfering with treatment/testing; and (d) inability to undertake standing transfers and/or walk a few steps (with a walker).

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 21, 2026