Baby HABIT-ILE intervention: study protocol of a randomised controlled trial in infants aged 6-18 months with
Astrid Carton de Tournai1, Enimie Herman1, Estelle Gathy1,2
1Institute of Neuroscience, Université catholique de Louvain, Brussels, Belgium.
Insights
This study investigates the baby Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (baby HABIT-ILE) for infants with unilateral cerebral palsy (CP). Early intensive therapy may prevent negative neuroplastic changes in young children with CP.
Area of Science:
- Pediatric Neurology
- Neurorehabilitation
- Developmental Pediatrics
Background:
- Animal models suggest intensive motor training can prevent maladaptive neuroplasticity in infants with cerebral palsy (CP).
- The efficacy of such interventions in infants with CP to prevent secondary neurological damage remains unassessed.
- Unilateral CP affects motor skill development in infants, necessitating early intervention strategies.
Purpose of the Study:
- To evaluate the effect of the baby Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (baby HABIT-ILE) on infants with unilateral CP.
- To compare the outcomes of immediate baby HABIT-ILE intervention versus a control intervention.
- To assess the potential of early intensive therapy to mitigate secondary neurological damage in infants with CP.
Main Methods:
- A randomized controlled trial involving 48 infants with unilateral CP (aged 6-18 months).
- Participants were paired by age and CP etiology, then randomized into immediate or delayed intervention groups.
- Assessments included the Mini-Assisting Hand Assessment (primary outcome), motor skills, cognitive-language abilities, MRI, and kinematics over 6 months.
Main Results:
- Data collection and analysis are ongoing; results are pending.
- The study is designed to provide quantitative and qualitative data on the intervention's effectiveness.
- Parent-reported goals and participation metrics will also be analyzed.
Conclusions:
- The study will determine if baby HABIT-ILE is effective in improving outcomes for infants with unilateral CP.
- Findings may inform clinical practice regarding early neurorehabilitation for infants with CP.
- This research could establish a new standard of care for preventing long-term neurological deficits.
Introduction:
Research using animal models suggests that intensive motor skill training in infants under 2 years old with cerebral palsy (CP) may significantly reduce, or even prevent, maladaptive neuroplastic changes following brain injury. However, the effects of such interventions to tentatively prevent secondary neurological damages have never been assessed in infants with CP. This study aims to determine the effect of the baby Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (baby HABIT-ILE) in infants with unilateral CP, compared with a control intervention.
Methods And Analysis:
This randomised controlled trial will include 48 infants with unilateral CP aged (corrected if preterm) 6-18 months at the first assessment. They will be paired by age and by aetiology of the CP, and randomised into two groups (immediate and delayed). Assessments will be performed at baseline and at 1 month, 3 months and 6 months after baseline. The immediate group will receive 50 hours of baby HABIT-ILE intervention over 2 weeks, between first and second assessment, while the delayed group will continue their usual activities. This last group will receive baby HABIT-ILE intervention after the 3-month assessment. Primary outcome will be the Mini-Assisting Hand Assessment. Secondary outcomes will include behavioural assessments for gross and fine motricity, visual-cognitive-language abilities as well as MRI and kinematics measures. Moreover, parents will determine and score child-relevant goals and fill out questionnaires of participation, daily activities and mobility.
Ethics And Dissemination:
Full ethical approval has been obtained by the Comité d'éthique Hospitalo-Facultaire/Université catholique de Louvain, Brussels (2013/01MAR/069 B403201316810g). The recommendations of the ethical board and the Belgian law of 7 May 2004 concerning human experiments will be followed. Parents will sign a written informed consent ahead of participation. Findings will be published in peer-reviewed journals and conference presentations.
Trial Registration Number:
NCT04698395. Registered on the International Clinical Trials Registry Platform (ICTRP) on 2 December 2020 and NIH Clinical Trials Registry on 6 January 2021. URL of trial registry record: https://clinicaltrials.gov/ct2/show/NCT04698395?term=bleyenheuft&draw=1&rank=7.
