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  • Clinical Research Article
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Home-based early intensive manual therapy in unilateral cerebral palsy under 2 years of age

Pediatric Research (2025)Cite this article

ABSTRACT

Background

Children with unilateral cerebral palsy (UCP) learn not to use their affected upper limb, which is known as “developmental disregard”. Consequently, early intensive training could improve hand function, increasing spontaneous use for the first 2 years of life, where there is a great window for brain changes due to neural plasticity.

Objective

To study the effectiveness of home-based infant-intensive manual therapies in facilitating bimanual functional performance (BFP) compared to standard care in children with UCP aged 9–18 months.

Methods

A randomized controlled trial with single-blinded outcome assessment was conducted. Children were randomized into four groups: modified Constraint-Induced Movement Therapy for infants (infant-mCIMT), Bimanual Intensive Therapy for infants (InfantBIT), Hybrid Therapy, combining mCIMT and BIT, for infants (Infant-hybrid) and conventional therapy for children (Infant-standard-Therapy, control group-CG). Each early intensive protocol lasted 50 h and was applied throughout a 10-week period. The main outcomes were BFP, functional goals and parental satisfaction expectations regarding intensive manual therapy. Three measurements were performed (at Week 0, Week 10 and 6 months after treatment).

Results

Forty infants aged 12.38 months (chronological age) met the inclusion criteria. All groups except CG showed significant increases in BFP after infant intensive manual therapy and at 6 months compared with the baseline assessment (p < 0.01). The greatest increases in goal achievement and parent satisfaction occurred in the groups that had an mCIMT component.

Conclusions

Compared with standard therapy, early intensive manual therapies, i.e., infant-mCIMT, infant-BIT and infant-Hybrid therapy, resulted in greater increases in BFP and were maintained at the 6-month follow-up.

Clinical trial registration

ClinicalTrials.gov: NCT06191588.

Impact

  • Home-based early intensive manual therapies increase bimanual functional performance to a greater extent than conventional therapy.

  • Infant-Hybrid therapy may result in greater improvements in functional bimanual performance compared to Infant-mCIMT or Infant-BIT alone.

  • Higher therapy intensity and family involvement, particularly in home-based programs, are key factors for improving hand function compared to lower-dose, clinic-based usual care.

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Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

The authors would like to thank all the families and infants for their collaboration in the study.

Author information

Authors and Affiliations

  1. Faculty of Physiotherapy and Nursing, Department of Nursing, Physiotherapy and Occupational Therapy, University of Castilla-La Mancha, UCLM, Toledo, Spain

    Rocío Palomo-Carrión, Cristina Lirio-Romero, Helena Romay-Barrero & Asunción Ferri-Morales

  2. ImproveLab Research Group in Paediatric Physiotherapy and Neurology, Toledo, Spain

    Rocío Palomo-Carrión & Cristina Lirio-Romero

  3. HemiChild Research Unit, UCLM, Toledo, Spain

    Rocío Palomo-Carrión & Cristina Lirio-Romero

  4. Faculty of Nursing, Physiotherapy and Podiatry, Department of Physiotherapy, University of Seville, Seville, Spain

    Elena Pinero-Pinto

  5. Instituto de Biomedicina de Sevilla-IBiS (Hospitales Universitarios Virgen del Rocío y Macarena/CSIC/Universidad de Sevilla), Seville, Spain

    Elena Pinero-Pinto

  6. Faculty of Health Sciences, University of Málaga, Málaga, Spain

    Rita-Pilar Romero-Galisteo

  7. Málaga Biomedical Research Institute and Nanomedicine Platform (IBIMA BIONAND Platform), Málaga, Spain

    Rita-Pilar Romero-Galisteo

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  1. Rocío Palomo-Carrión
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  2. Elena Pinero-Pinto
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Contributions

Conceptualization: R.P.C., H.R.B., E.P.P. and C.L.R.; methodology: R.P.C., R.P.R.G., A.F.M., H.R.B. and E.P.P. writing—original draft preparation: R.P.C., R.P.R.G., A.F.M., H.R.B., C.L.R. and E.P.P.; writing—review and editing: R.P.C., R.P.R.G. and E.P.P. All the authors have read and agreed to the published version of the manuscript.

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Correspondence to Elena Pinero-Pinto.

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Palomo-Carrión, R., Pinero-Pinto, E., Lirio-Romero, C. et al. Home-based early intensive manual therapy in unilateral cerebral palsy under 2 years of age. Pediatr Res (2025). https://doi.org/10.1038/s41390-025-04306-4

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