Shall we start? Ready, set, go! Toward early intervention in infants with unilateral cerebral palsy. A randomized
Rocío Palomo-Carrión1,2, Elena Pinero-Pinto3, Helena Romay-Barrero1,2
1Faculty of Physiotherapy and Nursing, Department of Nursing, Physiotherapy and Occupational Therapy, University of Castilla- La Mancha (UCLM), Toledo, Spain.
Insights
Early intensive therapies improve bimanual functional performance in infants with unilateral cerebral palsy. These home-based interventions, including infant-mCIMT and infant-BIT, show effectiveness in enhancing upper limb function.
Area of Science:
- Pediatric Rehabilitation
- Neuroscience
- Developmental Pediatrics
Background:
- Early intervention is critical for unilateral cerebral palsy (CP).
- Activity-based intensive therapies are the focus for CP management.
- Unilateral CP impacts bimanual functional performance.
Purpose of the Study:
- To evaluate changes in bimanual functional performance (BFP) in infants with unilateral CP.
- To compare early intensive home-based therapies with standard care.
- To assess children aged 9 to 18 months.
Main Methods:
- A single-blind comparative effectiveness study.
- Randomization into four groups: infant-mCIMT, infant-BIT, infant-hybrid, and standard therapy (control).
- 50-hour intensive protocols over 10 weeks with family involvement; outcomes measured by mini-AHA, GAS, and parent questionnaires.
Main Results:
- Intensive interventions demonstrated effectiveness in improving BFP.
- Increased spontaneous use of the affected upper limb was observed.
- Results align with previous studies on intensive therapies for CP.
Conclusions:
- Early intensive therapies, including various protocols, are effective for unilateral CP.
- Home-based intensive programs show promise in enhancing BFP.
- Further research supports the efficacy of applied doses in intensive interventions.
Background:
It is crucial to start an early intervention in unilateral cerebral palsy. Intensive therapies are focused on training based on activities.
Objective:
The objective of the study was to study the changes in the bimanual functional performance (BFP) after early intensive therapies at home compared with standard care in children with unilateral cerebral palsy from 9 to 18 months of age.
Design:
A single-blind comparative effectiveness study will be conducted.
Methods And Analysis:
Children will be randomized into four groups: infant-mCIMT, infant-BIT, infant-hybrid, and infant standard therapy (control group, CG). Each early intensive protocol will last 50 h and will be applied throughout a 10-week period with the family involvement at home. The main outcomes are BFP measure with mini-Assisting Hand Assessment (mini-AHA) scale, functional goals measure with Goal Attainment Scale (GAS), and satisfaction and expectations on intensive therapy from parents measure through specific questionnaire. Baseline characteristics between groups will be compared using independent t test and Fisher's exact test. Pre- and post-treatment outcomes of standard assessments will be compared using analysis of variance (ANOVA) for parametric and Kruskal-Wallis test for non-parametric variables. The Bonferroni correction is applied for multiple comparisons. An alpha level of p ⩽ 0.05 is considered significant.
Discussion:
In relation to other studies that have analyzed intensive therapies, although with fewer intervention groups, it seems that the application of any of the intensive interventions is effective with the applied dose to obtain changes in BFP and increase the spontaneous use of the affected upper limb.
Registration:
ClinicalTrials.gov Identifier: NCT04642872.
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