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START-Play intervention for Cerebral Palsy (START-Play Trial)

N/A
Waitlist Available
Led By Michele A. Lobo, PhD
Research Sponsored by Duquesne University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, at end of 3 month intervention, and at 6 and 12 months after baseline
Awards & highlights

START-Play Trial Summary

This study is evaluating whether a set of activities can improve motor skills in infants with neuromotor dysfunction.

Eligible Conditions
  • Developmental Delay
  • Cerebral Palsy
  • Infant Development

START-Play Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, at end of 3 month intervention, and at 6 and 12 months after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at end of 3 month intervention, and at 6 and 12 months after baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bayley Scales of Infant Development III
Secondary outcome measures
Change in Duration (Time) of Toy Contacts
Change in Early Problem Solving Indicator (EPSI)
Change in Frequency (Number) of Toy Contacts
+3 more
Other outcome measures
Change in Postural Measure of Trunk Angle

START-Play Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: START-Play interventionExperimental Treatment1 Intervention
Intervention incorporating cognitive factors and focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months.
Group II: Business as UsualActive Control1 Intervention
Early motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
START-Play intervention
2016
N/A
~140

Find a Location

Who is running the clinical trial?

Duquesne UniversityLead Sponsor
30 Previous Clinical Trials
2,294 Total Patients Enrolled
University of DelawareOTHER
154 Previous Clinical Trials
25,077 Total Patients Enrolled
5 Trials studying Cerebral Palsy
164 Patients Enrolled for Cerebral Palsy
University of WashingtonOTHER
1,738 Previous Clinical Trials
1,844,217 Total Patients Enrolled
10 Trials studying Cerebral Palsy
1,070 Patients Enrolled for Cerebral Palsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Efficacy of the START-Play Program for Infants With Neuromotor Disorders
2016. "Efficacy of the START-Play Program for Infants With Neuromotor Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02593825.
~14 spots leftby Apr 2025
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