Telemedicine in Early Childhood Constraint Therapy for Cerebral Palsy
This study is looking at different ways to help infants with cerebral palsy (a condition affecting movement and muscle tone) improve the use of their arms. It compares two active treatments delivered through telehealth: APPLES-tele, which involves wearing a soft-constraint on the less affected arm and therapist-guided tasks, and a Parent-centered Approach (PCA) Support Intervention, which focuses on positive parenting principles. There's also a group receiving standard care. Researchers will measure changes in arm movement and parenting styles to see which approach is most helpful. Infants between 4 and 13 months old who have or are at high risk for cerebral palsy, with specific arm asymmetry, may be able to join. The study plans to enroll 267 participants.
- Study design
- This is an interventional study comparing two active treatments and standard care in infants with cerebral palsy. The planned enrollment is 267 participants.
- What's involved
- Participants will receive 5 weekly telehealth sessions over a 6-week period for the APPLES-tele or PCA interventions. Measurements will be taken at baseline, after the first intervention (Week 6), and after the second intervention (Week 12).
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 12 weeks, with measurements taken at Week 6 and Week 12 after the interventions begin.
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Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy
At a glance
Conditions
Where it's being run
4 sites across 4 statesStudy leadership
- Nathalie Maitre, MD, PhD · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in Bayley Scales of Infant and Toddler Development (Bayley-3) More Affected Arm Motor Function ScoreBaseline, Week 6 (after the first intervention), Week 12 (after the second intervention)
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.
- Change in Parenting Styles and Dimensions Questionnaire (PSDQ) Authoritative Scale ScoreBaseline, Week 6 (after the first intervention), Week 12 (after the second intervention)
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.