APPLES-tele for Cerebral Palsy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cerebral PalsyAPPLES-tele - Other
Eligibility
4 - 13
All Sexes
What conditions do you have?
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Study Summary

This trial is testing two different treatments for cerebral palsy in infants, compared to a standard of care group.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)

Week 6
Change in Bayley Scales of Infant and Toddler Development (Bayley-3) Global Fine Motor Function Score
Change in Hand Assessment in Infants (HAI) Score
Change in Infant Motor Activity Log (IMAL) How Often Score
Change in Maternal Confidence Questionnaire (MCQ) Score
Change in Welch Emotional Connection Screen (WECS) Score
Week 12
Change in Bayley Scales of Infant and Toddler Development (Bayley-3) More Affected Arm Motor Function Score
Change in Bayley Scales of Infant and Toddler Development (Bayley-4) Motor Scale Score
Change in Parenting Styles and Dimensions Questionnaire (PSDQ) Authoritative Scale Score

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Standard of Care Control Arm
1 of 3
APPLES-tele first, then PCA
1 of 3
PCA first, then APPLES-tele
1 of 3

Active Control

Experimental Treatment

267 Total Participants · 3 Treatment Groups

Primary Treatment: APPLES-tele · No Placebo Group · N/A

APPLES-tele first, then PCAExperimental Group · 3 Interventions: Parent-centered Approach (PCA) Support Intervention, APPLES-tele, Standard of Care · Intervention Types: Behavioral, Other, Behavioral
PCA first, then APPLES-teleExperimental Group · 3 Interventions: Parent-centered Approach (PCA) Support Intervention, APPLES-tele, Standard of Care · Intervention Types: Behavioral, Other, Behavioral
Standard of Care Control Arm
Behavioral
ActiveComparator Group · 1 Intervention: Standard of Care · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of Care
2017
Completed Phase 4
~10020

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 6 (after the first intervention), week 12 (after the second intervention)

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,509 Previous Clinical Trials
2,705,739 Total Patients Enrolled
2 Trials studying Cerebral Palsy
86 Patients Enrolled for Cerebral Palsy
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,827 Previous Clinical Trials
2,249,871 Total Patients Enrolled
27 Trials studying Cerebral Palsy
8,044 Patients Enrolled for Cerebral Palsy
Nathalie Maitre, MD, PhDPrincipal InvestigatorEmory University
1 Previous Clinical Trials
130 Total Patients Enrolled

Eligibility Criteria

Age 4 - 13 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of CP or a high-risk classification for CP as determined by published guidelines.
You have a positive HINE score and/or neuroimaging consistent with perinatal involvement.
Hand Assessment for Infants (HAI) difference between hands ≥3 as determined by HAI-certified study therapists.