NCT04997109 · Emory University
Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy
(APPLES-TELE)
What this study is about
This study assesses two active treatments in different sequences and a the usual treatment group among infants with cerebral palsy.
View original scientific description
This study assesses two active treatments in different sequences and a standard of care group among infants with cerebral palsy.
Interventions
OTHER
APPLES-tele
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.
BEHAVIORAL
Parent-centered Approach (PCA) Support Intervention
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.
BEHAVIORAL
Standard of Care
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.
Primary outcome measures
Change in Bayley Scales of Infant and Toddler Development (Bayley-3) More Affected Arm Motor Function Score
Time frame: Baseline, 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 Score
Time frame: Baseline, 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Aged 4 to 13 months, corrected age
- Diagnosis of CP or classification of high-risk for CP as determined by published guidelines (\>95% risk of later CP)
- Hammersmith Infant Neurological Exam (HINE) arm asymmetry score of greater than or equal to 2 and/or neuroimaging consistent with perinatal involvement
- Hand Assessment for Infants (HAI) difference between hands ≥2, with an observable and relative difference in quality or amount of movement between hands, as determined by HAI-certified study therapists and/or a unimanual Bayley score difference between hands \>1
- Parent/legal guardian is able to provide informed consent
Exclusion criteria
- Congenital malformation of the brain or musculoskeletal system (MSK)
- Receipt of botulinum toxin to the affected extremity within 3 months of study entry
- Any prior long-term hard constraint programs
Where
- Atlanta, Georgia
- Baltimore, Maryland
- Philadelphia, Pennsylvania
- Salt Lake City, Utah
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 14, 2025 · Source of record for eligibility and locations