Physical Therapy for Infant Motor Delay

Recruiting at 2 trial locations

Overseen By Elizabeth Hoffman, DPT

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Anticoagulants

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

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Study Aims Pilot study: Due to the large recruitment goal and length of the project, the study team/PIs will evaluate the first cohort of 6-10 participants to refine study procedures and study-related materials. If no major modifications are made to the protocol as a result of this evaluation, data from these participants will be included for analysis. Aim 1: Evaluate the efficacy of an early, evidence-based, clinical experience-based therapeutic intervention (from the NICU to 12-months corrected age) on improving motor function and reducing severity of motor delays in infants at 12-months corrected age. The investigators hypothesize that the intervention group will demonstrate an average 8-point difference (0.5 standard deviation) compared to the standard of care group. \[an 8-point difference is considered a clinically meaningful difference\] Aim 2: Evaluate the early effects (i.e., before 12 months) of a therapeutic intervention, provided from NICU to 12-months corrected age, on motor function and severity of motor delay. The Investigators hypothesize that a statistically significant higher percentage of infants in the intervention group will demonstrate improved motor function and reduced severity of motor delays, compared to the standard of care group-assessed using sensors, the NSMDA and TIMP-as early as 3-months corrected age. Aim 3: Evaluate whether an early intervention that focuses on caregiver engagement improves caregiver well-being. The invetigators hypothesize that an intervention that focuses on supporting and addressing the individual needs of the caregiver will improve caregiver well-being. The investigators will evaluate these effects using the PedsQL (Family Impact Module).

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 data supports the effectiveness of the treatment Physical Therapy for Infant Motor Delay?

Research shows that structured neonatal physical therapy can improve neurobehavior and general movements in moderate to late preterm infants, suggesting potential benefits for infants with motor delays. ^{1 2 3 4 5}

Is physical therapy safe for infants?

Research on physical therapy for infants, including those at high risk for developmental issues, shows no significant safety concerns. Studies have not reported harmful effects, suggesting it is generally safe for infants. ^{1 3 5 6 7}

How does physical therapy differ from other treatments for infant motor delay?

Physical therapy for infant motor delay is unique because it involves hands-on techniques and exercises to improve motor skills, rather than using medications or surgical interventions. It focuses on enhancing movement and coordination through structured activities, which can be administered by therapists or parents, making it a non-invasive and interactive approach. ^{1 2 3 6 8}

Research Team

Arun Jayaraman, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Physical Therapy intervention (Behavioural 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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Early physical therapy effects on the high-risk infant: a randomized controlled trial. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Early Parent-Administered Physical Therapy for Preterm Infants: A Randomized Controlled Trial. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Neonatal PT Improves Neurobehavior and General Movements in Moderate to Late Preterm Infants Born in India: An RCT. [2023]

4. United States 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. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of developmental intervention in the neonatal intensive care unit: implications for neonatal physical therapy. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

The effects of physical therapy on cerebral palsy. A controlled trial in infants with spastic diplegia. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Development of a quantitative tool to assess the content of physical therapy for infants. [2010]

8. United States pubmed.ncbi.nlm.nih.gov

Physical therapy for neonates with respiratory dysfunction. [2019]