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Specialized vs Standard Physical Therapy for Cerebral Palsy (SIT-PT Trial)

N/A
Recruiting
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Dx or clinical signs of cerebral palsy (CP) previously described
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to the end of the intervention, up to 12 months
Awards & highlights

SIT-PT Trial Summary

This trial will compare the effectiveness of two physical therapy interventions for infants at risk for Cerebral Palsy.

Who is the study for?
This trial is for young children aged 8-24 months with or at high risk of Cerebral Palsy. They must have a gross motor delay, be able to prop sit for a few seconds, focus visually on objects and show some spontaneous arm movement. Children with severe visual impairments, certain congenital anomalies, uncontrolled seizures or progressive disabilities are not eligible.Check my eligibility
What is being tested?
The study compares two physical therapy methods in toddlers: START-Play focuses on sitting, reaching and problem-solving skills to boost overall development; Usual Care Physical Therapy aims to improve motor skills and prevent impairments related to CP.See study design
What are the potential side effects?
Since the interventions involve physical therapy techniques rather than medications, typical drug side effects are not expected. However, there may be fatigue or discomfort associated with the exercises during or after sessions.

SIT-PT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with or show signs of cerebral palsy.

SIT-PT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to the end of the intervention, up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to the end of the intervention, up to 12 months 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 sitting behavior
Secondary outcome measures
Change in Cognitive skills
Change in Language
Change in fine motor skills
+1 more
Other outcome measures
Assessment of Problem Solving in Play

SIT-PT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: START-Play InterventionExperimental Treatment1 Intervention
Sitting Together And Reaching to Play is an intervention designed to work on motor-based problem-solving. Thus the activities keep thinking skills at the forefront while also working on advancing motor skills. When initially developed to work with children who were emerging sitters the motor tasks focused on sitting and reaching resulting in the name.
Group II: Movement, Orientation, Repetition, and Exercise (MORE-PT) - Usual Care Physical TherapyActive Control1 Intervention
This intervention was based on the observations of usual care from a previous study. Key principles included the use of Movement, Orientation, Repetition, and Exercise thus the intervention name was changed to MORE-PT before enrollment started. This reduced bias as the therapists and families were not informed this was usual care which could have biased them.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
914 Previous Clinical Trials
1,602,796 Total Patients Enrolled
9 Trials studying Cerebral Palsy
250 Patients Enrolled for Cerebral Palsy

Media Library

START-Play Physical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04230278 — N/A
Cerebral Palsy Research Study Groups: Movement, Orientation, Repetition, and Exercise (MORE-PT) - Usual Care Physical Therapy, START-Play Intervention
Cerebral Palsy Clinical Trial 2023: START-Play Physical Therapy Highlights & Side Effects. Trial Name: NCT04230278 — N/A
START-Play Physical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04230278 — N/A

Frequently Asked Questions

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

Are participants currently being accepted for this research endeavor?

"Accessing the information hosted on clinicaltrials.gov, one can ascertain that this experiment is in need of participants. It was first posted to the public domain on March 1st 2021 and it has been amended most recently on April 26th 2022."

Answered by AI

Is there an age requirement for participation in this research project?

"This clinical trial has particular requirements for enrolment, with the age range of participants being from 8 months to 24 months old. Additionally, there are 140 trials available for minors and 26 trials designed specifically for senior citizens aged 65 or above."

Answered by AI

What are the eligibility criteria for participants of this clinical trial?

"150 candidates are being accepted into this research trial, all of whom must have cerebral palsy and be between 8 months to 24 months old."

Answered by AI

Who else is applying?

What site did they apply to?
University of Washington
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy
Stacey Dusing 2021. "Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04230278.
All > Cerebral Palsy
~34 spots leftby Apr 2025
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