Your session is about to expire
← Back to Search
Physical Therapy for Infant Motor Delay
N/A
Recruiting
Led By Arun Jayaraman, PT, PhD
Research Sponsored by Shirley Ryan AbilityLab
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 at each assessment timepoint, including study enrollment, monthly up to 3 months corrected age (ca), 3-month ca, 6-months ca, 9-months ca, 12-months ca, 18-months ca (optional), and 24-months ca (optional).
Awards & highlights
Study Summary
This trial tests the effects of an intervention (from the NICU to 12-months corrected age) on motor function and caregiver well-being in infants. Results will help refine procedures & materials, compare to standard of care, & measure effects at 3-months corrected age.
Who is the study for?
This trial is for infants in the NICU at risk of motor delays due to conditions like low birth weight, brain injuries, or bronchopulmonary dysplasia. They must be stable and able to start therapy between 34-48 weeks postmenstrual age. Infants with severe health issues, open wounds, bleeding disorders, or under DCFS custody are excluded.Check my eligibility
What is being tested?
The study tests a physical therapy intervention from the NICU until the infant reaches 12 months corrected age. It aims to improve motor function and reduce severity of delays compared to standard care. The impact on caregiver well-being is also assessed.See study design
What are the potential side effects?
Since this trial involves physical therapy interventions for infants rather than medication or invasive procedures, significant side effects are not anticipated as commonly seen in drug trials.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at each assessment timepoint, including study enrollment, monthly up to 3 months corrected age (ca), 3-month ca, 6-months ca, 9-months ca, 12-months ca, 18-months ca (optional), and 24-months ca (optional).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at each assessment timepoint, including study enrollment, monthly up to 3 months corrected age (ca), 3-month ca, 6-months ca, 9-months ca, 12-months ca, 18-months ca (optional), and 24-months ca (optional).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bayley-4 motor score at 12-months corrected age
Secondary outcome measures
Bayley-4 Cognitive score Bayley-4 Cognitive score Bayley-4 Cognitive score
Movement quality assessed by wearable sensors
Pediatric Quality of Life Inventory (PedsQL)
Other outcome measures
Alberta Infant Motor Scale (AIMS)
Bayley-4 Cognitive domain
General Movement Assessment (GMA)
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Physical Therapy InterventionExperimental Treatment1 Intervention
Infants enrolled in this arm will receive the intervention in addition to standard of care
Group II: Standard of CareActive Control1 Intervention
Infants enrolled in this arm will receive standard of care
Find a Location
Who is running the clinical trial?
Northwestern UniversityOTHER
1,586 Previous Clinical Trials
917,059 Total Patients Enrolled
1 Trials studying Motor Delay
150 Patients Enrolled for Motor Delay
University of Illinois at ChicagoOTHER
609 Previous Clinical Trials
1,559,117 Total Patients Enrolled
1 Trials studying Motor Delay
150 Patients Enrolled for Motor Delay
Shirley Ryan AbilityLabLead Sponsor
194 Previous Clinical Trials
16,720 Total Patients Enrolled
1 Trials studying Motor Delay
150 Patients Enrolled for Motor Delay
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My baby was admitted to the NICU and qualifies for special follow-up care.I have a disorder affecting my brain, such as injury or developmental issue.My baby needed breathing support at 36 weeks after conception and was born before 32 weeks.I don't have open wounds or skin conditions that would prevent sensor placement.My body weight is less than 1500 grams.I am medically stable and can start the treatment between 34-48 weeks after conception.I have a bleeding disorder or need ongoing blood thinners.
Research Study Groups:
This trial has the following groups:- Group 1: Physical Therapy Intervention
- Group 2: Standard of Care
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
May I be a participant in this research project?
"Potential participants of this clinical trial must be between 33 and 48 weeks old, with a diagnosis of brain ischemia. This study aims to include 192 patients in total."
Answered by AI
What is the cap for participant enrollment in this research project?
"Affirmative. Clinicaltrials.gov states that this experiment is actively seeking participants since October 1st 2022, and last updated on the 24th of October 2022. This endeavour seeks to recruit 192 individuals from 2 separate medical sites."
Answered by AI
Is registration currently available for this clinical examination?
"As per the records on clinicaltrials.gov, this medical trial is actively enrolling patients and was first posted in October 1st 2022 with a recent amendment to it's protocol occurring 24 days later."
Answered by AI
Does this experimental protocol include participants that are older than twenty?
"Eligibility for this trial is restricted to patients between 33 and 48 weeks of age. Furthermore, there are 347 studies for participants under 18 years old and 470 trials designed for people over the age of 65."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger