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Physical Therapy for Cerebral Palsy in Infants
N/A
Recruiting
Led By Barbara Sargent, PhD, PT
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if a new physical therapy can help infants at risk of cerebral palsy.
Who is the study for?
This trial is for infants diagnosed with cerebral palsy or those at high risk, indicated by brain imaging and specific neurological exam scores. Infants must be able to see toys and respond to sounds, weigh under 50 lbs, and live in an area accessible for home visits.
What is being tested?
The study tests the practicality of a program where babies do standing and walking exercises at home. It aims to understand if this intervention can help infants with or at high risk of developing cerebral palsy.
What are the potential side effects?
Since this is a physical therapy intervention involving standing and walking exercises tailored for infants, side effects may include muscle soreness or fatigue. However, serious side effects are not commonly expected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of the in-home standing and walking intervention
Secondary study objectives
Bayley Scales of Infant and Toddler Development, 4th edition (Bayley-4)
Gross Motor Function Measure (GMFM-88)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: In-home standing and walking interventionExperimental Treatment1 Intervention
Infants will participate in the in-home standing and walking intervention for 16 weeks. In addition, infants will continue with any intervention in the community recommended by their health care team.
Find a Location
Who is running the clinical trial?
California Physical Therapy AssociationUNKNOWN
Cerebral Palsy FoundationUNKNOWN
1 Previous Clinical Trials
1,500 Total Patients Enrolled
1 Trials studying Cerebral Palsy
1,500 Patients Enrolled for Cerebral Palsy
University of Southern CaliforniaLead Sponsor
946 Previous Clinical Trials
1,604,611 Total Patients Enrolled
9 Trials studying Cerebral Palsy
384 Patients Enrolled for Cerebral Palsy
Barbara Sargent, PhD, PTPrincipal InvestigatorUniversity of Southern California, Division of Biokinesiology and Physical Therapy
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Cerebral Palsy
12 Patients Enrolled for Cerebral Palsy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My infant is at high risk for or has been diagnosed with cerebral palsy.My epilepsy does not improve with medication.My infant cannot respond to sounds due to hearing issues.I weigh more than 50 lbs.My child cannot see toys well enough to play with them.
Research Study Groups:
This trial has the following groups:- Group 1: In-home standing and walking intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.