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HABIT-ILE: A randomised trial of hand arm bimanual intensive training including lower extremity training for children with bilateral cerebral palsy

HABIT-ILE: A randomised trial of hand arm bimanual intensive training including lower extremity training to improve manual ability and gross motor function for children with bilateral cerebral palsy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000164291
Acronym
HABIT-ILE
Enrollment
92
Registered
2018-02-02
Start date
2018-08-20
Completion date
2021-01-30
Last updated
2023-10-23

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 126 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: We will deliver a total dose of 65 hours of HABIT-ILE. The 65 hours of HABIT-ILE will be achieved through a 2 week intensive group delivered day camp for 6.5 hrs/day over 10 days. The model of HABIT-ILE to be tested has been adapted to maximise future clinical translation to ensure acceptability and feasibility to children with bilateral CP and their f

HABIT-ILE is a motor learning approach simultaneously addressing coordination of the upper and lower limbs. Key elements of HABIT-ILE are: Dose: We will deliver a total dose of 65 hours of HABIT-ILE. The 65 hours of HABIT-ILE will be achieved through a 2 week intensive group delivered day camp for 6.5 hrs/day over 10 days. The model of HABIT-ILE to be tested has been adapted to maximise future clinical translation to ensure acceptability and feasibility to children with bilateral CP and their families in Australia. Mode: Groups of 10-12 children delivered (1:1 or 2:1 therapist / volunteer / student to child ratio according to ability). Content and tailoring: Upper extremity: Intervention will be based on the child’s motor abilities (determined at baseline), age, interests and self-identified functional goals. Tasks/activities are made incrementally more challenging. Practice is structured, using whole task practice with high repetition and ongoing feedback about performance. Tasks that will be performed include: (i) incremented table top fine motor activities; (ii) activities of daily living when standing/walking; (iii) gross motor play and physical activities. Based on the pilot study of HABIT-ILE, we expect that 40% of the time will be spent engaged in activities requiring gross upper limb dexterity, 30% on activities of daily living, 20% manipulative games, and 10% on other card games, arts and crafts. Lower extremity: Based on the child’s motor abilities, postural control/sitting balance will be progressed from sitting on a stool to sitting on fitness balls to build core strength; progression of standing balance with use of balance boards. Based on the pilot study of HABIT-ILE, we expect that sessions will be structure so that 40% of time is spent sitting on fitness balls, 20% sitting on stools, 20% standing and 20% walking/running. Intervention providers: Physiotherapists and occupational therapists delivering HABIT-ILE will complete standardised training provided by the developer of HABIT-ILE. This will coincide with the first intensive intervention camp conducted. The trained therapists will in turn train and supervise therapy students and coach parents to deliver HABIT-ILE. Target intensity: We expect that sessions will be structured so that 40% of time is spent sitting on fitness balls, 20% sitting on stools, 20% walking/running, 40% of the time will be spent engaged in activities requiring gross upper limb dexterity, 30% on activities of daily living, 20% manipulative games, and 10% on other card games, arts and crafts. Fidelity: Standardised therapist training will be provided to therapists employed to deliver the intervention. the training package will include: • Intervention manual • Onsite training during the first HABIT-ILE camp lead by a master trainer Training sessions will be video recorded and accessible at any time for established or new therapists delivering the intervention. All group intervention sessions will be videotaped and a random selection viewed for fidelity adherence and competence criteria.

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
6 Years to 16 Years
Healthy volunteers
No

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 6 to 16 years; (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

(a) uncontrolled seizures (b) orthopaedic surgery in the six months prior to or scheduled during study period (eligible for inclusion if at least 12 months orthopedic 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: Feb 20, 2026