Physical Therapy for Infant Motor Delay

Recruiting at 2 trial locations

Overseen By Elizabeth Hoffman, DPT

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Anticoagulants

Disqualifiers: Open wounds, Immune deficiencies, Limb defects, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: Up to 12 months

222 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a specific physical therapy can improve motor skills in infants showing signs of motor delays. It focuses on babies who have spent time in the Neonatal Intensive Care Unit (NICU) and have conditions like brain injuries or serious lung issues. The trial compares the new therapy with usual care to determine if it significantly impacts motor development by 12 months and examines its effects on caregivers' well-being. Infants who have been in the NICU and are medically stable between 34-48 weeks postmenstrual age may be suitable for this study. As an unphased trial, this study provides a unique opportunity to enhance understanding of how new therapies can support infant development.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that this physical therapy intervention is safe for infants?

Research shows that starting physical therapy early can be safe and helpful for babies with movement delays. Studies have found that these therapies not only improve motor skills but are also generally well-tolerated by young children. Importantly, no major negative effects have been reported in studies using physical therapy to treat motor delays, indicating that the treatment is safe for infants and helps improve their movement abilities.

Physical therapy engages the baby in specific exercises and activities that support their development. These activities are usually low-risk and customized to each child's needs, making them a safe choice for addressing movement delays. While the current study continues to examine the procedures, existing research supports the safety and effectiveness of this approach for infants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the physical therapy intervention for infant motor delay because it offers a proactive approach that goes beyond the standard care, which typically involves monitoring or minimal intervention. Unlike traditional treatments that may focus on later stages of motor development, this intervention targets early motor skills, potentially accelerating developmental milestones. By integrating specialized physical therapy techniques, it aims to enhance motor function more effectively and earlier in life, providing infants with a stronger foundation for future growth and development.

What evidence suggests that this physical therapy intervention is effective for infant motor delay?

Research shows that physical therapy can significantly help infants with motor delays improve their movement skills. Studies have found that these therapies enhance abilities like reaching, problem-solving, thinking, and fine motor skills in young infants. In this trial, infants in the Physical Therapy Intervention arm will receive therapy in addition to standard care. One study found that infants who received therapy had better movement abilities and less severe delays than those who only received standard care. The START-Play program, a specific type of physical therapy, positively affected movement and thinking skills in infants with movement disorders. These findings suggest that starting physical therapy early can be a helpful treatment for infants with delayed motor development. ^{1 2 6 7 8}

Who Is on the Research Team?

Arun Jayaraman, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Exclusion Criteria

Followed primarily in another clinic (including meningomyelocele and related conditions/trisomy 21)

Any other condition that would preclude participation in the study, as determined by the PI

Previously enrolled in competing randomized trial with developmental outcome variables

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants receive a physical therapy intervention from NICU to 12-months corrected age, with up to two therapist visits per week in addition to standard care.

Up to 12 months

Up to 2 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 12-months corrected age and optional assessments at 18 and 24-months corrected age.

12 months with optional extensions

Assessments at 12, 18, and 24 months corrected age

Optional Extension

Optional assessments and caregiver surveys at 18 and 24-months corrected age to monitor long-term outcomes.

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Physical Therapy intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Physical Therapy Intervention Experimental Treatment 1 Intervention

Infants enrolled in this arm will receive the intervention in addition to standard of care

Group II: Standard of Care Active Control 1 Intervention

Infants enrolled in this arm will receive standard of care

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Northwestern Medicine

Collaborator

Trials

14

Recruited

9,500+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials

275

Recruited

5,182,000+

Published Research Related to This Trial

Chest physical therapy is increasingly recognized as a beneficial intervention for neonates with pulmonary dysfunction, with specific techniques tailored to address various neonatal respiratory conditions.

The article outlines important considerations for physical therapists, including indications, contraindications, and precautions for chest physical therapy, while also highlighting the need for further research to optimize treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy for neonates with respiratory dysfunction. Crane, L.[2019]

In a study of 48 infants with spastic diplegia, those who received 6 months of infant stimulation followed by 6 months of physical therapy (Group B) showed significantly better motor and mental quotients compared to those who received only physical therapy for 12 months (Group A).

After 12 months, infants in Group B were more likely to walk and had higher motor and mental quotients, suggesting that infant stimulation may be more beneficial than traditional physical therapy alone for early intervention in cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of physical therapy on cerebral palsy. A controlled trial in infants with spastic diplegia. Palmer, FB., Shapiro, BK., Wachtel, RC., et al.[2019]

A structured neonatal physical therapy program (SNP) significantly improved neurobehavior and general movements in moderate to late preterm infants, as shown by assessments conducted on 60 infants in a clinical trial.

Infants receiving the SNP showed better scores in motor development and a decrease in poor repertoire general movements compared to those receiving usual care, suggesting that this therapy can enhance developmental outcomes in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neonatal PT Improves Neurobehavior and General Movements in Moderate to Late Preterm Infants Born in India: An RCT. Khurana, S., Rao, BK., Lewis, LE., et al.[2023]

A systematic observation protocol was developed to analyze physical therapy interventions for infants at high risk for developmental disorders, specifically focusing on 42 therapy sessions for infants aged 4 to 6 months.

The study found that about 40% of therapy time was dedicated to encouraging independent motor behavior, while 30% involved facilitation techniques, demonstrating a structured approach to therapy that can be reliably documented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a quantitative tool to assess the content of physical therapy for infants. Blauw-Hospers, CH., Dirks, T., Hulshof, LJ., et al.[2010]

A review of 26 articles on developmental intervention techniques in the NICU found that sensory techniques used by physical therapists are effective for promoting sensorimotor development in preterm infants, with 12 articles rated highly for their quality.

Despite the consensus on the benefits of developmental interventions, the lack of large, well-controlled studies makes it difficult to pinpoint the specific effectiveness of individual healthcare professionals, including physical therapists, in the NICU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of developmental intervention in the neonatal intensive care unit: implications for neonatal physical therapy. Mahoney, MC., Cohen, MI.[2019]

In a study of 72 very preterm infants with very low birth weight, physical therapy (PT) intervention did not significantly improve motor performance at four months corrected age, but it did prevent abnormal motor development in the treatment group compared to the nontreatment group.

Higher parental compliance with the PT intervention was associated with better motor scores, suggesting that engagement from parents may enhance the effectiveness of early physical therapy in reducing motor delays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of an early physical therapy intervention for very preterm, very low birth weight infants: a randomized controlled clinical trial. Cameron, EC., Maehle, V., Reid, J.[2019]

A study involving 153 preterm infants showed that parent-administered physical therapy significantly improved motor performance by 37 weeks' postmenstrual age compared to usual care, with a notable effect size of 0.40.

The intervention, which included activities promoting postural control and head control, was conducted for just 10 minutes twice a day over 3 weeks, suggesting that even brief, targeted physical therapy can have beneficial effects on motor development in medically stable preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Parent-Administered Physical Therapy for Preterm Infants: A Randomized Controlled Trial. Ustad, T., Evensen, KA., Campbell, SK., et al.[2018]

A study involving 134 high-risk infants showed that early physical therapy did not lead to significant improvements in neurologic status, motor development, or physical growth compared to conventional care at 12 months.

Infants born weighing less than 750 g consistently experienced significant delays in growth and development, regardless of whether they received early physical therapy or not, indicating that very low birth weight is a critical factor in developmental outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early physical therapy effects on the high-risk infant: a randomized controlled trial. Piper, MC., Kunos, VI., Willis, DM., et al.[2007]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33382406/

START-Play Physical Therapy Intervention Impacts Motor ... START-Play may advance reaching, problem solving, cognitive, and fine motor skills for young infants with significant motor delay over UC-EI in the short term.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05568264

Effects of a Physical Therapy Intervention on Motor Delay ... A randomized controlled trial to evaluate the efficacy of a physical therapy intervention to improve motor function and reduce the severity of motor delays.

3. ies.ed.gov ies.ed.gov/use-work/awards/efficacy-start-play-program-infants-neuromotor-disorders

Efficacy of the START-Play Program for Infants with ... START-Play physical therapy intervention impacts motor and cognitive outcomes in infants with neuromotor disorders: A multisite randomized clinical trial .

4. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2022.877345/full

Effects of Early Motor Interventions on Gross Motor and ... To systematically examine the effect of early motor interventions on motor and locomotor development in infants <1 year of age with motor developmental ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7910024/

START-Play Physical Therapy Intervention Impacts Motor ... START-Play may advance reaching, problem solving, cognitive, and fine motor skills for young infants with significant motor delay over UC-EI in the short term.

6. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0291408

Protocol for a randomized controlled trial to evaluate a year ... Current evidence suggests that early therapeutic intervention reduces the severity of motor delay by harnessing neuroplastic potential during ...

7. publications.aap.org publications.aap.org/pediatrics/article/131/6/e2016/31072/Motor-Delays-Early-Identification-and-Evaluation

Motor Delays: Early Identification and Evaluation | Pediatrics Motor delays may be the first or most obvious sign of a global developmental disorder. For infants, motor activities are manifestations of early development. It ...

8. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2025.1576324/full

Early rehabilitation interventions for global developmental ... Physical therapy constitutes a cornerstone of early intervention strategies for children with developmental delays affecting motor skills and functional ...