Feasibility of home-based early infant hybrid therapy in children with unilateral cerebral palsy

Citation: Palomo-Carrión, R.; Romay-Barrero, H.; Pinero-Pinto, E.; Romero-Galisteo, R.-P.; Coello- Villalón, M.; Ferri-Morales, A.; López-Muñoz, P.; Lirio-Romero, C. Feasibility of Home-Based Early Infant Hybrid Therapy in Children with Unilateral Cerebral Palsy. J. Clin. Med. 2024,13, 6725. https://doi.org/ 10.3390/jcm13226725 Academic Editors: Torbjörn Ledin and Katja E. Wartenberg Received: 29 August 2024 Revised: 24 September 2024 Accepted: 7 November 2024 Published: 8 November 2024 Copyright: © 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https:// creativecommons.org/licenses/by/ 4.0/). Article Feasibility of Home-Based Early Infant Hybrid Therapy in Children with Unilateral Cerebral Palsy Rocío Palomo-Carrión1,2 , Helena Romay-Barrero 1,* , Elena Pinero-Pinto 3,4 , Rita-Pilar Romero-Galisteo 5,6 , María Coello-Villalón 1,2 , Asunción Ferri-Morales 1 , Purificación López-Muñoz 1,2 and Cristina Lirio-Romero 1,2 1Faculty of Physiotherapy and Nursing of Toledo, University of Castilla-La Mancha, Avenida Carlos III, s/n, 45071 Toledo, Spain; [email protected] (R.P.-C.); [email protected] (M.C.-V.); [email protected] (A.F.-M.); [email protected] (P.L.-M.); [email protected] (C.L.-R.) 2ImproveLab, Research Group in Pediatric Physiotherapy and Neurology, 45071 Toledo, Spain 3Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Avicena Street s/n, 41009 Seville, Spain; epiner[email protected] 4Biomedicine Institute of Seville (IBIS), 41013 Seville, Spain 5Department of Physiotherapy, Faculty of Health Sciences, University of Málaga, C/Arquitecto Peñalosa, 29071 Málaga, Spain; rpromer[email protected] 6Biomedicine Institute of Málaga (IBIMA), 29590 Málaga, Spain *Correspondence: helena.r[email protected] Abstract: Background: The first stage of childhood is characterized by great neuronal plasticity. In Unilateral Cerebral Palsy (UCP), it is essential to carry out early treatment, with family involvement. The aim of this study was to investigate the feasibility of Early Infant Hybrid Therapy (eI-Hybrid) applied at home with family involvement in children with UCP aged 9–18 months, and to assess its preliminary effectiveness on bimanual functional performance. Methods: A single group of 10 children (12.8 months, SD = 3.4) performed the eI-Hybrid therapy. The main outcome was measured with the mini Assisting Hand Assessment scale (mini-AHA), functional goals were measured with the Goal Attainment Scale (GAS), and satisfaction expectations on intensive therapy were also recorded. Three measures were performed (week 0, week 10, and month 6). A repeated-measures ANOVA test was performed on the mini-AHA in order to observe the statistically significant differences in pairwise comparison. Results: Ten children completed the study and the parents’ expectations were fulfilled, indicating high caregiver compliance and high adherence to the treatment. Clinically relevant changes were observed between pre- and post-intervention measurements in BFP (pre: 41.9 (SD: 7.7), post: 50.9 (SD: 6.0) and in the follow-up at 6 months (50.3 (SD:5.6); p< 0.001). Families reported a high satisfaction. Conclusions: infant hybrid treatment is feasible to be performed at home with the family’s involvement, obtaining improvements in the affected upper limb for early-age UCP. Keywords: early age; family; home; infantile hemiplegia; intensive therapy; upper extremity 1. Introduction Cerebral palsy (CP) is the most common motor disability in childhood, characterized as a group of lifelong disorders affecting movement and posture, resulting in activity limitations [ 1 ]. Unilateral cerebral palsy (UCP) represents approximately 30% of all CP cases [ 2 ]. Children with UCP are specifically associated with sensorimotor deficits predominantly on one side of the body. These challenges typically manifest as difficulties with tasks involving grasping, releasing, and manipulating objects. Therefore, children with UCP experience the impaired function of one upper limb, which can hinder their ability to perform bimanual activities and negatively impact their overall development [3]. The remarkable plasticity of the young brain, especially within the first two years of life, underscores the importance of initiating therapeutic interventions at an early age [ 4 ]. Early training programs designed to enhance hand function are crucial in mitigating the J. Clin. Med. 2024,13, 6725. https://doi.org/10.3390/jcm13226725 https://www.mdpi.com/journal/jcm J. Clin. Med. 2024,13, 6725 2 of 18 risk of “developmental disregard”, where the affected limb is neglected by the child [ 5 ]. These programs should include age-specific interventions with therapy goals that are both task- and context-specific to maximize their effectiveness. Research indicates that certain motor impairments associated with CP can be partially reversed during this critical developmental window through early, intensive motor skill training [4]. Furthermore, studies emphasize the importance of actively involving parents and caregivers in the therapeutic process. Therapists should guide and support parents, helping them build their capacity and confidence, which in turn strengthens the parent–infant relationship and improves treatment adherence [ 6 ]. When parents feel well-supported, they are more likely to be actively involved in therapy, which can reduce their stress levels and enhance the effectiveness of the intervention. This is particularly important since early intervention programs are often home-based, relying on parents to deliver therapy [7]. Early therapeutic intervention carried out at home is critical during infancy, as it coincides with a period of rapid neural plasticity, offering a unique opportunity to influence motor outcomes positively [ 8 ]. Research has demonstrated that interventions within the first two years of life can significantly impact the motor and cognitive development of children with UCP [ 9 ]. Among these interventions, a recent review showed a small effect in the comparison of task-specific motor training with standard care for improving motor function, and a moderate effect for constraint-induced movement therapy (CIMT), compared with bimanual play or massage for improving the function of the more-affected hand [ 10 ]. Modified Constraint-Induced Movement Therapy (mCIMT) involves concurrent physical restraint of the less-affected hand and unilateral training of the more-affected hand and is typically less intensive than CIMT and flexible in terms of session length or frequency [ 11 , 12 ]. Bimanual Intensive Therapy (BIT) is a functional training method that uses intensive repetitive practice to increase both hands’ coordination with structured task practice through bimanual play and functional activities [ 13 , 14 ]. BIT and mCIMT have both shown promise in improving upper limb function in children older than 2 years [15–17] . Emerging evidence [ 18 – 20 ] suggests that combining these two approaches—creating an eI-Hybrid protocol—may offer enhanced therapeutic benefits by simultaneously promoting the use of the affected limb while also fostering the development of bimanual coordination [21,22]. The theoretical and practical benefits of the application of an early infant hybrid therapy (eI-Hybrid) approach in infants are widely demonstrated in the scientific literature, its use being recommended to improve upper limb function for children with UCP [15,19,23] . However, in young children, specifically in those aged 9–18 months, this remains largely unexplored. This age group presents unique challenges and opportunities, given their rapid developmental changes and the need for age-appropriate therapy protocols [ 24 ]. Understanding the feasibility of implementing such a hybrid intervention in this critical developmental window is essential for designing effective early intervention strategies. The purpose of this study is to assess the bimanual functional performance increase in the affected upper limb and the feasibility of infant hybrid therapy applied at home with family involvement in children with UCP aged 9–18 months. 2. Materials and Methods 2.1. Study Design The design selected was a single-group study, to test the feasibility of an early infant hybrid home protocol (eI-Hybrid). This protocol consisted of 50 h of intensive training (involving at least two sessions per week for a period of time) [ 25 ] divided into 25 h of bimanual intensive therapy (BIT) and 25 h of modified Constraint-Induced Movement Therapy (mCIMT). The parents were the main deliverers of the intervention. Before the study began, parents were provided with the written informed consent. This study was registered in ClinicalTrials.gov with the identification number NCT06191588. J. Clin. Med. 2024,13, 6725 3 of 18 A single-group design was selected for this initial feasibility study due to its focus on evaluating the practicality and potential impact of the intervention within a natural home setting. Including a control group was considered but deemed premature, as the main objective was to explore whether parents could effectively implement the eI-Hybrid protocol and whether children would tolerate and respond to the therapy. Additionally, this design allowed for the refinement of the protocol before advancing to more complex, controlled trials. To mitigate potential biases, several strategies were implemented. Firstly, standardized outcome measures [ 26 – 30 ] were used to reduce observer bias. Secondly, parents received detailed training to ensure consistency in administering the intervention. Thirdly, the data collection process was blinded to the maximum extent possible, with independent assessors evaluating the pre- and post-intervention outcomes. These measures aimed to enhance the reliability of the findings, despite the absence of a control group. 2.2. Participants The participants were recruited from pediatric hospitals, specifically 12 de Octubre and La Paz in Madrid, and the University Hospital of Toledo, as well as from the association of unilateral cerebral palsy (HEMIWEB) in Spain, based on the established inclusion and exclusion criteria. The inclusion criteria were as follows: diagnosis of spastic UCP; being 9–18 months old; being able to understand and respond to basic and age-appropriate instructions (short, simple words with a clear order—take, drop, give me, move the toy, for example—used without generating possible doubts and with understanding for the young child); and the agreement from the parents to participate. Exclusion criteria included additional medical issues such as respiratory problems, which can affect a child’s ability to participate effectively in physical activities (e.g., asthma or chronic bronchitis), as well as intractable epilepsy and prior treatments such as medications, botulinum toxin injections, and surgeries. Additionally, a score of 4 points in the amount of use and initially used items indicated that there were no highly noticeable differences in the spontaneous use of the affected upper limb in relation to the less affected one on the main outcome measure (mini- AHA), indicating no significant functional difference between the hands; this was also a reason for exclusion. We also ensured that none of the recruited children were enrolled in other physical therapy programs during the study. These eligibility criteria were designed to ensure that any observed effects could be attributed with greater confidence to the hybrid therapy being evaluated, without confounding influences from other interventions. The study was approved on 30 October 2020, by the Ethics Committee of the University of Malaga (Reference N: 75-2020-H), in accordance with the World Medical Association Declaration of Helsinki. 2.3. Early Infant Hybrid Therapy (eI-Hybrid) The early intervention eI-Hybrid lasted 50 h for 10 weeks, with the participation of the family at home. The children would be motivated to perform the arranged activities in two periods of 30 min each day (from Monday to Friday). The first 30 min consisted of single-handed activities, following mCIMT considerations; these would be followed (not continued) by activities aimed at using both hands for 30 min, based on the considerations of BIT. In the first part, the restriction in the less-affected upper limb was be achieved by using a long-sleeve T-shirt with a clip at the end of the sleeve (Figure 1). The restraint was only used during the session. The toys were first be placed close to the baby’s hand to facilitate contact, and then at a greater distance, when the child gained greater manual skill. To monitor improvement in manual skills, an approach based on the following three key indicators was used and explained to the families: the time it took the child to reach and manipulate the toys, the assistance provided by parents, and the need for compensatory postural adjustments. J. Clin. Med. 2024,13, 6725 4 of 18 J. Clin. Med. 2024, 13, x FOR PEER REVIEW 4 of 19 key indicators was used and explained to the families: the time it took the child to reach and manipulate the toys, the assistance provided by parents, and the need for compensatory postural adjustments. Figure 1. Long-sleeved T-shirt restriction in left upper limb for use of affected upper limb, inducing shoulder flexion into specific activity to touch balloons. On the other hand, in the BIT program, children with a lower ability will start with bimanual reaching and holding. The objects will need to be easy to grasp so that the children can hit, crash, or shake them. The toys will be selected based on the child’s age and motor ability. For those children with a lower level of motor skills, the toys will need to be presented within reaching distance to promote reaching and touching. In this case, the activities performed (Table 1) will be designed to train the desired components of movements required to complete the goal tasks and to be fun and motivating to facilitate cooperation and learning. Table 1. Activities proposed to perform in infant hybrid therapy. Movements Unimanual Examples (Infant CIMT Part) Using More-Affected Upper Limb/Hand Bimanual Examples (Infant BIT Part) Using Both Upper Limbs/Hands Action Type Shoulder flexion Throw a ball, touch different objects located at different heights, touch balloons, reach different rattles, use toys that are offered at different distances. Throw a big ball, touch different objects located at different heights, touch big balloons, put on necklaces, hats, reach different rattles, use toys that are offered at different distances. Reaching actions Elbow extension Push a box with different weights, throw towers, put paint on paper at a distance so that it can stretch, throw a ball, reach different rattles, with toys that are offered at different distances. Push a box with different weights, throw towers, throw a ball, reach different rattles,use toys that are offered at different distances. Reaching actions Forearm supination Turn around a toy, put food in the mouth, give them objects in the palm of the hand, play the toy trumpet. Move maracas or other toys between hands, manipulate an object, give them objects in the palm of both hands, put marbles in a bottle (held with the moreaffected hand). Manipulating actions and grasping actions Figure 1. Long-sleeved T-shirt restriction in left upper limb for use of affected upper limb, inducing shoulder flexion into specific activity to touch balloons. On the other hand, in the BIT program, children with a lower ability will start with bimanual reaching and holding. The objects will need to be easy to grasp so that the children can hit, crash, or shake them. The toys will be selected based on the child’s age and motor ability. For those children with a lower level of motor skills, the toys will need to be presented within reaching distance to promote reaching and touching. In this case, the activities performed (Table 1) will be designed to train the desired components of movements required to complete the goal tasks and to be fun and motivating to facilitate cooperation and learning. Table 1. Activities proposed to perform in infant hybrid therapy. Movements Unimanual Examples (Infant CIMT Part) Using More-Affected Upper Limb/Hand Bimanual Examples (Infant BIT Part) Using Both Upper Limbs/Hands Action Type Shoulder flexion Throw a ball, touch different objects located at different heights, touch balloons, reach different rattles, use toys that are offered at different distances. Throw a big ball, touch different objects located at different heights, touch big balloons, put on necklaces, hats, reach different rattles, use toys that are offered at different distances. Reaching actions Elbow extension Push a box with different weights, throw towers, put paint on paper at a distance so that it can stretch, throw a ball, reach different rattles, with toys that are offered at different distances. Push a box with different weights, throw towers, throw a ball, reach different rattles, use toys that are offered at different distances. Reaching actions Forearm supination Turn around a toy, put food in the mouth, give them objects in the palm of the hand, play the toy trumpet. Move maracas or other toys between hands, manipulate an object, give them objects in the palm of both hands, put marbles in a bottle (held with the more-affected hand). Manipulating actions and grasping actions Wrist extension, finger extension, opening hand Squeeze playdough, move sand, pick up sand and drop it, pick up a round rattle or ball, play the toy piano. Squeeze playdough, move sand, pick up sand and drop it, pick up a round rattle or ball, play the toy piano, stretching plasticine, colliding two round toys, clapping while singing a song. Reaching actions, manipuling actions, and grasping actions Fine grasp Move balls of different sizes, uncover objects by pulling the handle, pick up cereals, bits of biscuit. Breaking pieces of paper, putting the marbles in the bottle with the more-affected hand, moving a small object from one hand to another hand. Grasping actions J. Clin. Med. 2024,13, 6725 5 of 18 Activities and positioning during the play session: Depending on the actions present in the chosen objective, as well as the child’s age and ability, the pediatric physiotherapist, together with the family, determined which activities would be worked on each week, increasing the difficulty if a better execution was acquired. The aim was for movements to be self-generated, voluntary, and challenging yet attainable. During the play session, the infant would be seated with an upright and symmetrical trunk to enhance the movement of the paretic upper limb. This may have taken place in a highchair, on the floor, or in an adapted seating device. The parents would stand opposite the child and on the affected side to offer toys in different positions to increase reach distance and the range of upper limb movement. Time was provided for the infant to explore the objects and develop their own skills. To attract the child’s attention, toys with sound were be used. 2.4. Family Training The home program is designed to align with motor learning principles, taking into the consideration of different factors within both the following interventions: the active involvement of the child and the family, and goal-oriented, structured, and individualized functional tasks suitable for the child, based on their interests, motivation, and manual ability. The physiotherapist joins the family for choosing toys and setting play at an appropriate ability level and amount of repetitions of tasks [ 31 ]. The tasks include grasping, and unimanual and bimanual exploration and manipulation of the toys, so they need to have different features to prompt different actions. Goals are established with the Goal Attainment Scale (GAS) [ 26 , 27 ] based on their daily routines. In addition, to train families to perform the therapy at home, training will be given beforehand, with a duration of two days, for 4 h each day, during which the therapy will be explained and the potential activities to be planned during eI-Hybrid are aligned with the child’s motivations and preferences, and will be taught. To make the task easier, and improve the family’s confidence, adjustments to the initial positioning of the child can be made, such as avoiding the inclination and anteriorization of the trunk, using an appropriate seat and the right height in relation to the table (for those activities that are carried out in sitting position). There can also be modifications to the object choice and their positioning will be close to the child at the start of the treatment. Prior to the start, each family will be asked about their child’s interests and preferences with regard to playing, which activities the child found the most difficult, and what motivates or frustrates them. On the day of training, they will create a list from those interests and preferences to show the parents how they should perform them during the intervention: what the more-affected arm/hand should do and whether it should assist or be the main hand during the bimanual task. 2.5. Supervision of Families A pediatric physiotherapist will perform a weekly review through online sessions aimed at solving queries the parents could have about the different therapies (unimanual or bimanual activities, restraint type or difficulties in its use, massage strokes, and so on), changing toys to increase difficulty, or providing the child with other motor actions and enhancing the positioning of the child, all of this taking place through the reviewing of the videos of the proposed games. Families could have time to comment on their experiences, difficulties, and how they feel during the implementation of the intervention. In addition, each family will have to fill out a monitoring sheet, including the toys used in each session and what objectives were set for their use, how the infant was positioned, how their interaction was (rejection, tired, active), the time spent on it (to check the adherence of the child and the family in the therapy), and compliance with the dosage. Data collection was conducted through the monitoring sheets filled out by the families, which were collected at the end of each session. These sheets provided quantitative data on the toys used and the duration of activities, as well as qualitative insights into the family’s experiences and challenges. J. Clin. Med. 2024,13, 6725 6 of 18 2.6. Outcome Measures 2.6.1. Feasibility The feasibility of intervention measures are outlined as follows: 1. Acceptability: we evaluated the comprehensibility of the rules of the game regarding preparation and execution. This was measured using video analysis during the planning of the games, focusing on how to position the child on the table and their orientation to facilitate task execution. 2. Training compliance: The compliance with the intervention duration (10 weeks) was documented through weekly reviews. These included oral reports from parents regarding their adherence to the therapy schedule and confirmation of completed sessions. 3. Training smoothness: We examined the smoothness of activities by recording the number of problems and difficulties encountered. These data were be gathered through weekly documents that assessed task execution times and noted instances of rejection or interest in activities. 4. Training motivation: The motivation and perceived effort of the child was evaluated through direct observation during therapy sessions. Observers recorded behavioral indicators of engagement, and parents completed a questionnaire about their expectations prior to therapy and after the 50 h of intervention. This questionnaire contains five questions, each with five possible answers (see Supplementary Materials). 2.6.2. Procedure Outcomes The administration and evaluation procedure for the various tests used is described below. All outcome measures were administered and scored by trained, expert raters. In the case of the mini-AHA and AHA assessments, these are used to record a play session that was then be scored by a certified rater, unaware of the group assignment. Outcome measures were be collected at 3 time points (week 0, week 10, and 6 months post-treatment), except for functional goals and participant satisfaction and expectations, which were be measured at week 0 and week 10. Mini Assisting Hand Assessment (mini-AHA) Outcome The Bimanual Functional Performance (BFP) was be assessed using the infant version of the Assisting Hand Assessment scale (mini-AHA) [28], and the Assisting Hand Assessment scale (AHA) [ 29 , 30 ]. Both measurements were used to examine the impact of the treatment on the bimanual performance of the affected upper limb. The mini-AHA is a validated, reliable, criterion-referenced test based on observation that measures how effectively infants with ages between 8 and 18 months with hemiplegia use their more-affected hand. The Assisting Hand Assessment v. 5.0 scale [ 32 , 33 ] was used in infants participating in therapy who were older than 18 months at the 6-month follow-up evaluation. To facilitate the interpretation of results, the logit scale is converted to a user-friendly 0–100 scale that is still Rasch-based and presents interval level data (namely, mini-AHA/AHA units). In addition, a clinically meaningful change is obtained with 5 AHA units of difference pre–post treatment scores. Goal Attainment Scale (GAS) The Goal Attainment Scale [ 26 , 27 ] was the tool used to measure functional goals. This is a widely used measurement tool to assess individualized attributes where no standardized measure exists. The GAS evaluates the degree to which goals have been achieved with the intervention. Goal-setting procedure: prior to the intervention, a collaborative process was employed to establish specific functional goals for each child. This process involved several key steps: 1. Initial assessment: The therapeutic team conducted an initial assessment to understand the child’s current abilities and difficulties. This included gathering information from standardized assessments, clinical observations, and input from family members. J. Clin. Med. 2024,13, 6725 7 of 18 2. Family engagement: Families would actively participate in discussions about their child’s needs, preferences and aspirations. Through structured interviews or focus groups, family members expressed their priorities for therapy, focusing on functional activities that would enhance their child’s daily life. 3. Goal identification: Based on the information gathered, the therapy team and families would collaboratively identify specific, measurable, attainable, relevant, and time-bound (SMART) goals. Each goal was be tailored to the child’s individual circumstances and focused on improving functional independence in areas such as self-care, communication, and mobility. 4. Review and refinement: The identified goals were reviewed to ensure that they were realistic and fitted the child’s developmental stage. The therapy team provided feedback and guidance to help families refine their goals as needed. 5. Documentation: Each goal was documented, clearly stating the desired outcomes and how they would be measured. This documentation serves as a reference throughout the intervention to track progress and make adjustments as needed, as well as to propose new goals once achieved. Each goal was scored from − 2 (current level of performance) through 0 (desired outcome) to +2 (much greater than expected outcome). As part of the GAS goal-setting process, families were asked to state the degree of importance of individual goals to them, using the following 4 options: not at all important (score: 0), a little important (score: 1), moderately important (score: 2), and very important (score: 3). The therapists ranked the difficulty of the goals using the 4 following options: not at all difficult (score: 0), a little difficult (score: 1), moderately difficult (score: 2), and very difficult (score: 3). The therapists’ ranking of a goal’s difficulty was not communicated to the patient. GAS [ 34 , 35 ] is useful in evaluating pediatric therapy services and is responsive to change. Satisfaction and Expectations from Parents Before performing the therapy, the parents had to complete a survey inspired by the Canadian Occupational Performance Measure (COPM) and referenced in the study by Ferre et al. [ 36 ]. This survey assessed their expectations regarding home-based therapies. After completing 50 h of therapy, parents filled out a second survey to evaluate their satisfaction with the program’s execution. Both questionnaires consist of five questions, each of them with five possible answers depending on what question was asked (see Supplementary Materials). 2.7. Statistical Analysis For the analysis of the feasibility outcomes, descriptive statistics were used to show general characteristics, with means (standard deviation) for quantitative data and percentages for qualitative data. A repeated-measures ANOVA test was performed on the BFP to observe the statistically significant difference between pairwise comparisons. The normality study was be undertaken through the Shapiro–Wilk test, and Greenhouse–Geisser adjustment was applied when the assumption of sphericity was violated (Mauchly’s test of sphericity, p< 0.05). Sphericity refers to the assumption that the variances of the differences between repeated measures are equal, which is required for accurate ANOVA results. When this assumption is violated, the Greenhouse–Geisser adjustment corrects for potential inaccuracies and reduces the risk of type I errors, ensuring a more reliable interpretation of the results. The results are shown as the mean and standard deviation (SD), with a confidence interval of 95%. All analyses were performed by using the v.29 SPSS software package. 3. Results Fifteen children were invited to participate in the study, but five were excluded. The reasons for exclusion were incidence of botulinum toxin (n = 3) and uncontrolled epilepsy J. Clin. Med. 2024,13, 6725 8 of 18 (n = 2), as is shown in Figure 2. A total of 10 children with a mean age of 12.8 months (3.4) were enrolled and completed the study. J. Clin. Med. 2024, 13, x FOR PEER REVIEW 8 of 19 2.7. Statistical Analysis For the analysis of the feasibility outcomes, descriptive statistics were used to show general characteristics, with means (standard deviation) for quantitative data and percentages for qualitative data. A repeated-measures ANOVA test was performed on the BFP to observe the statistically significant difference between pairwise comparisons. The normality study was be undertaken through the Shapiro–Wilk test, and Greenhouse–Geisser adjustment was applied when the assumption of sphericity was violated (Mauchly’s test of sphericity, p < 0.05). Sphericity refers to the assumption that the variances of the differences between repeated measures are equal, which is required for accurate ANOVA results. When this assumption is violated, the Greenhouse–Geisser adjustment corrects for potential inaccuracies and reduces the risk of type I errors, ensuring a more reliable interpretation of the results. The results are shown as the mean and standard deviation (SD), with a confidence interval of 95%. All analyses were performed by using the v.29 SPSS software package. 3. Results Fifteen children were invited to participate in the study, but five were excluded. The reasons for exclusion were incidence of botulinum toxin (n = 3) and uncontrolled epilepsy (n = 2), as is shown in Figure 2. A total of 10 children with a mean age of 12.8 months (3.4) were enrolled and completed the study. Figure 2. Infant hybrid flowchart. The age range of the parents was 34–45 years. Four families had completed higher education, and six families had a high school graduate or baccalaureate. The individual characteristics of the participants are shown in Table 2. Figure 2. Infant hybrid flowchart. The age range of the parents was 34–45 years. Four families had completed higher education, and six families had a high school graduate or baccalaureate. The individual characteristics of the participants are shown in Table 2. Table 2. Individual characteristics in children enrolled in infant hybrid therapy. Early Infant Hybrid Therapy (N = 10) Mean (SD) IR Age 12.8 (3.4) 9.8–16.3 Mini-AHA Basal situation 41–9 (7.7) 34.8–50.3 N % Sex Female 6 60 Male 4 40 Affected upper limb Left 6 60 Right 4 40 Unilateral Cerebral Palsy cause Perinatal stroke 10 100 Postnatal stroke 0 0 Other 0 0 Birth (gestational age) Extremely premature 0 0 Moderately premature 3 30 Not premature 7 70 Associated disorders Epilepsy 0 0 Other disorders 0 0 No disorders 10 100 J. Clin. Med. 2024,13, 6725 9 of 18 The age and mini-AHA basal situation scores are shown with the mean and standard deviation (SD) and interquartile range (IR). The rest of the results are shown in percentages (%). Extremely premature (37 gestational weeks); moderately premature (28–37 gestational weeks); not premature (>37 gestational weeks); perinatal stroke (from 20 weeks of fetal life to 28 days postnatal life); postnatal stroke (after 28 days postnatal life). 3.1. Feasibility Outcomes Regarding the feasibility outcome, the following can be highlighted: (1) Participation willingness: all eligible families (100%) agreed to join the project. (2) Participation rates/infants’ adherence (participants’ compliance with the dosed/prescribed exercise sessions in the program), and adverse event reports completed by parents: For the infant hybrid therapy, the rate of adherence was very high, at 97% (48.5/50 h), and there was no dropout during that period of treatment. Parents felt very satisfied with the intervention and no complication was added when they were asked about the stressful situations during the program. A dose of 90–95% was a high adherence, taking as a reference the study by Ferre et al. [ 37 ]. (3) Assessment procedures: All outcome measures were collected during the assessments and there were no missing data. (4) Assessment time scale: follow-up data were collected as planned. (5) Follow-up dropout: There was no follow-up dropout for any participant who finished the training. All parents understood and completed the weekly online review. 1. Acceptability: families reported adequate preparation and execution of activities, with no complications encountered. 2. Training compliance: all children successfully completed the therapy within the designated 10-week period. 3. Training smoothness: families demonstrated a clear understanding of how to implement activities with their infants. Initial suggestions were provided to enhance both children’s and parents’ positioning at the beginning of treatment, leading to smooth execution without complications. 4. Training expectations and functional goals: Parents’ expectations (Table 3), captured through questionnaires, evolved over time. Initially, many felt unprepared to carry out the therapy; however, as they gained self-confidence through initial training and ongoing weekly reviews with physiotherapists, their involvement in the intervention improved significantly. Table 3. Parents’ satisfaction outcomes. Outcomes Qo1 Qo2 Qo3 Qo4 Qo5 Pre Post Pre Post Pre Post Pre Post Pre Post Mean (SD) 3.4 (0.5) 1.6 (0.5) 4 (0) 2.0 (0) 4.4 (0.5) 1.4 (0.5) 3.5 (0.5) 1.1 (0.3) 3.0 (0) 1.0 (0) pValue 0.004 * 0.002 * 0.002 * 0.004 * 0.002 * All values are expressed as the mean and standard deviation (SD). Qo, question; pre, pre-treatment; post: posttreatment; * indicates a value of statistical significance, when p< 0.05; BPF (0–100). Questions: Q1—how do you think the intervention will fit into your day to day? Q2—do you think your child will pay attention to the execution of the activities? Q3—how do you think your child will tolerate the intervention? Q4—how will you as a parent tolerate the intervention? Q5—do you think you will have the feeling of wanting to repeat it? All questions asked to parents obtained a significant value after 10 weeks of treatment, with the highest increase (2.4/5 points) observed in question 4 (Q4), related to the parent’s tolerance for the intervention. 3.2. Mini Assisting Hand Assessment (Mini-AHA) Outcomes The bimanual functional performance score measured with the mini-AHA scale showed improvements after 10 weeks of treatment (p= <0.001), with an increase (9 units). J. Clin. Med. 2024,13, 6725 16 of 18 4. Nelson, C.A.; Sullivan, E.; Engelstad, A. Annual Research Review: Early intervention viewed through the lens of developmental neuroscience. J. Child Psychol. Psychiatry 2024,65, 435–455. [CrossRef] 5. Houwink, A.; Aarts, P.B.; Geurts, A.C.; Steenbergen, B. A neurocognitive perspective on developmental disregard in children with hemiplegic cerebral palsy. Res. Dev. Disabil. 2011,32, 2157–2163. [CrossRef] 6. Akhbari Ziegler, S.; Hadders-Algra, M. 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