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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

Must not have

Medical complications that severely limit assessments/intervention participation such as severe visual impairment, congenital/orthopedic anomalies that limit sitting or reaching, or uncontrolled seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to the end of the intervention, up to 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with or show signs of cerebral palsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe health issues that would prevent me from participating in assessments or interventions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to the end of the intervention, up to 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in sitting behavior

Secondary study objectives

Change in Cognitive skills

Change in Language

Change in fine motor skills

+1 more

Other study objectives

Assessment of Problem Solving in Play

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met