La telemedicina nella terapia costrittiva della prima infanzia nella paralisi cerebrale (APPLES-TELE)

Participants receiving the APPLES-tele intervention for 6 weeks followed by the PCA intervention for 6 weeks.

The APPLES-tele intervention is 5 weekly telehealth sessions of therapist-demonstrated tasks, delivered over a 6 week period. Infant participants wear a soft-constraint harness (C-Mitt) on their less affected arm for 6 hours per day, while their parent encourages them to use their more affected arm to complete play-based activities as instructed by the study therapist. As the infant experiences success, heavier objects are provided. During times when the C-Mitt is not worn, parents engage therapist-demonstrated bimanual play of increasing difficulty.

• C-guanto

The PCA support intervention is 5 weekly telehealth sessions delivered over a 6 week period. The PCA curriculum includes 5 basic principles of positive parenting from Triple P: ensuring a safe engaging environment, creating a positive learning environment, using assertive discipline, having reasonable expectations, and looking after yourself as a parent. All of these elements, when taught to parents in an individualized manner, can help promote responsivity, structure and expectations that are tailored to their child's condition and developmental stage. In addition, a curriculum of CP-specific knowledge will address the challenges unique to parents of children with CP, such as understanding principles of infant learning of new movements, challenges and solutions for self-directed activity in infants with CP.

Participants receiving the PCA intervention for 6 weeks followed by the APPLES-tele intervention for 6 weeks.

The APPLES-tele intervention is 5 weekly telehealth sessions of therapist-demonstrated tasks, delivered over a 6 week period. Infant participants wear a soft-constraint harness (C-Mitt) on their less affected arm for 6 hours per day, while their parent encourages them to use their more affected arm to complete play-based activities as instructed by the study therapist. As the infant experiences success, heavier objects are provided. During times when the C-Mitt is not worn, parents engage therapist-demonstrated bimanual play of increasing difficulty.

• C-guanto

The PCA support intervention is 5 weekly telehealth sessions delivered over a 6 week period. The PCA curriculum includes 5 basic principles of positive parenting from Triple P: ensuring a safe engaging environment, creating a positive learning environment, using assertive discipline, having reasonable expectations, and looking after yourself as a parent. All of these elements, when taught to parents in an individualized manner, can help promote responsivity, structure and expectations that are tailored to their child's condition and developmental stage. In addition, a curriculum of CP-specific knowledge will address the challenges unique to parents of children with CP, such as understanding principles of infant learning of new movements, challenges and solutions for self-directed activity in infants with CP.

Participants receiving the standard of care for 6 weeks.

Participants will receive the usual care from being followed in high-risk infant follow-up (HRIF) programs in the Early Detection and Intervention (EDI) Network.

The Bayley-3 instrument is a norm-referenced test assessing developmental delays in early childhood. The fine motor function of the more affected upper extremity is assessed using the 54 unimanual items of the Bayley-3 instrument. Responses are provided on a 3-point scale where 0 = the skill is not present, 1 = the skill is emerging, and 2 = the skill is mastered. Total unimanual fine motor raw scores for the more affected arm range from 0 to 108 where higher scores indicate greater fine motor function.

The Authoritative Parenting Style scale of the Parenting Styles and Dimensions Questionnaire (PSDQ) - short version, includes 15 items that are rated on a 5-point scale where 1 = never and 5 = always. The raw score ranges from 15 to 75 and higher scores indicate a more expression of the authoritative parenting style.

Parent perception of hand performance is assessed with the IMAL. The IMAL includes 20 items asking caregivers how often and how well the infant uses their less preferred hand. Responses are given on a 5-point Likert scale where 0 = not used and 5 = normal use. Raw scores on how often the infant uses their less preferred hand range from 0 to 100, with higher scores indicating more normal hand usage.

The HAI is an assessment evaluating quality and frequency of hand abilities in infants 3 to 12 months corrected age using a semi-structured 12-15 min videotaped play session that is scored by a certified therapist. There are 12 unimanual and 5 bimanual items, each is scored on a 3-point rating scale, of 0, 1, or 2 points. Each hand receives a raw score based upon performance on the unimanual items. The raw score for the more affected hand will be reported as a continuous variable. Total raw scores for the unimanual items range from 0 to 24 and higher scores indicate greater ability.

The Bayley-3 instrument is a norm-referenced test assessing developmental delays in early childhood. The fine motor function scale of the Bayley-3 instrument includes 66 items, and responses are provided on a 3-point scale where 0 = the skill is not present, 1 = the skill is emerging, and 2 = the skill is mastered. Total fine motor raw scores range from 0 to 132 where higher scores indicate greater fine motor function.

The WECS assesses parent-infant connection by examining four emotional connection dimensions of behavior: attraction, vocal communication, facial communication, and sensitivity. Items are rated on a 3-point scale where 1 = low and 3 = high. A WECS Mother (WECS-M) score is created by summing the four items for maternal connection while the four items for infant connection create a WECS Infant (WECS-I) score. Total WECS-M or WECS-I scores range from 4 to 12 where higher scores indicate greater connection.

The MCQ assesses parent knowledge and confidence in caring for and understanding their infant. The MCQ has 14 items which are scored on a 5-point scale where 1 = never and 5 = a great deal. Scores are reversed for some items and total scores range from 14 to 70. Higher scores indicate greater maternal confidence.