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Telemedicine-Based Constraint Therapy for Cerebral Palsy (APPLES-TELE Trial)

N/A

Recruiting

Led By Nathalie Maitre, MD, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of CP or classification of high-risk for CP as determined by published guidelines (>95% risk of later CP)

Aged 4 to 13 months, corrected age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 6 (after the first intervention), week 12 (after the second intervention)

Awards & highlights

APPLES-TELE Trial Summary

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

Who is the study for?

This trial is for infants aged 4 to 13 months at risk of or diagnosed with cerebral palsy, who have been patients in certain clinics. They must show arm movement differences and haven't had long-term constraint programs, brain or musculoskeletal malformations, or recent botulinum toxin treatments.Check my eligibility

What is being tested?

The study compares two active treatments: APPLES-tele and PCA Support Intervention against standard care. Infants will receive these interventions in different sequences to see which is more effective for early childhood development.See study design

What are the potential side effects?

As this trial involves non-pharmaceutical interventions focused on therapy and support, traditional side effects like those from medication are not applicable. However, there may be fatigue or frustration during the exercises.

APPLES-TELE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am diagnosed with or at high risk for cerebral palsy.

Select...

My child is between 4 to 13 months old, considering their corrected age.

APPLES-TELE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 6 (after the first intervention), week 12 (after the second intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 6 (after the first intervention), week 12 (after the second intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6 (after the first intervention), week 12 (after the second intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Bayley Scales of Infant and Toddler Development (Bayley-3) More Affected Arm Motor Function Score

Change in Parenting Styles and Dimensions Questionnaire (PSDQ) Authoritative Scale Score

Secondary outcome measures

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

+2 more

APPLES-TELE Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: PCA first, then APPLES-teleExperimental Treatment3 Interventions

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

Group II: APPLES-tele first, then PCAExperimental Treatment3 Interventions

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

Group III: Standard of Care Control ArmActive Control1 Intervention

Participants receiving the standard of care for 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard of Care

2017

Completed Phase 4

~4420

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,639 Previous Clinical Trials

2,560,379 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

1,964 Previous Clinical Trials

2,674,463 Total Patients Enrolled

29 Trials studying Cerebral Palsy

8,491 Patients Enrolled for Cerebral Palsy

Nathalie Maitre, MD, PhDPrincipal InvestigatorEmory University

1 Previous Clinical Trials

92 Total Patients Enrolled

Media Library

APPLES-tele Clinical Trial Eligibility Overview. Trial Name: NCT04997109 — N/A

Cerebral Palsy Research Study Groups: APPLES-tele first, then PCA, PCA first, then APPLES-tele, Standard of Care Control Arm

Cerebral Palsy Clinical Trial 2023: APPLES-tele Highlights & Side Effects. Trial Name: NCT04997109 — N/A

APPLES-tele 2023 Treatment Timeline for Medical Study. Trial Name: NCT04997109 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants accepted into this experiment?

"Affirmative. Clinicaltrials.gov has information that indicates that this research study is currently recruiting individuals, commencing from February 23rd 2022 and most recently updated on March 1st 2022. A total of 267 volunteers are needed at 4 different sites for the trial."

Answered by AI

Does this medical research include individuals above the age of 40?

"Per the inclusion criteria for this trial, those eligible to participate must be between 4 and 13 months of age."

Answered by AI

Do I fulfill the qualifications to take part in this clinical research?

"This trial is actively seeking 267 infants aged between 4 and 13 months with cerebral palsy. The inclusion criteria necessitates that these patients have a Hammersmith Infant Neurological Exam (HINE) arm asymmetry score of at least 2, evidence consistent with perinatal involvement on neuroimaging scans, an Hand Assessment for Infants (HAI) difference between hands ≥3 as determined by HAI-certified study therapists, be under the care of a participating neonatal intensive care unit (NICU), Early Developmental Clinic or stroke clinic and that their parent/legal guardian consents to participation."

Answered by AI

What are the key goals of this experiment?

"This clinical trial, which will span from Baseline to Week 6 and Week 12 marks, seeks to evaluate the Change in Bayley Scales of Infant and Toddler Development (Bayley-3) More Affected Arm Motor Function Score as its primary outcome. The secondary outcomes include: an assessment of Change in Bayley Scales of Infant and Toddler Development (Bayley-3) Global Fine Motor Function Score; a measurement of Change in Welch Emotional Connection Screen (WECS) Score; and finally a survey on Change in Infant Motor Activity Log (IMAL) How Often Score."

Answered by AI

What is the scope of individuals currently undergoing this clinical experiment?

"The clinical trial necessitates 267 individuals that meet the established criteria. Participation is open at Kennedy Krieger Institute in Baltimore, Maryland and Emory University in Atlanta, Georgia for interested patients."

Answered by AI

Are there any North American sites operating this experiment?

"Currently, 4 medical centres are accepting participants for this trial. These include Baltimore, Atlanta and Salt Lake City among others. If you plan to become a participant in the study, it is most convenient to choose a local location to reduce travel demands."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy

Nathalie Maitre 2022. "Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04997109.

All > Cerebral Palsy