Motor DelayNCT05568264
Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
A study testing Physical Therapy intervention in people with Motor Delay and Premature Birth, run by Shirley Ryan AbilityLab at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 33 to 48 weeks
- Conditions the study is for
- Motor Delay, Premature Birth, Intraventricular Hemorrhage
- What is being tested?
- Physical Therapy intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 33 to 48 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- NICU admission and qualifies for Early Childhood Clinic (NICU high-risk follow up clinic) or Early Intervention due to:
- BW <1500 grams
- OR
- Disorders of the central nervous system
- Brain injury (including but not limited to extra axial hemorrhage, any grade intraventricular or intraparenchymal hemorrhage, stroke, hypoxic ischemic encephalopathy (HIE), meningitis)
- HIE includes mild, moderate, severe exam on modified Sarnat exam, both cooled and non-cooled
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- includes "at risk for HIE" with 10-minute Apgar <7 plus pH<7.15 or base deficit >/=12.
- Brain developmental abnormalities (hydrocephalus, microcephaly, cortical dysgenesis)
- Cramped synchronous movements at term PMA
- OR
- Bronchopulmonary dysplasia (BPD) defined as need for respiratory support at 36 weeks postmenstrual age in an infant born at <32 weeks of gestation.
- AND
- Medically stable AND able to start intervention between 34-48 weeks PMA.
Who cannot join
- (related to inability to complete intervention, sensor placement, or clinic assessments)
- open wounds, skin condition precluding sensor placement
- immune deficiencies requiring protective isolation
- limb reduction defects
- followed primarily in another clinic (including but not limited to meningomyelocele and related conditions/trisomy 21)
- bleeding disorders or ongoing need for anticoagulation
Show all 13Show fewer
- palliative or hospice care (for life limiting conditions including, but not limited to trisomy 18, 13)
- known visual impairment at the time of enrollment
- DCFS custody
- no English-speaking caregivers
- 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
- Each child's enrollment in the study will be approved by the child's neonatologist.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Northwestern Medicine Prentice Children's Hospital
Chicago, Illinois, 60611
Children's Hospital at the University of Illinois
Chicago, Illinois, 60612
About this study
Official title: Early Detection and Therapeutic Improvement of Motor Delay in High Risk Infants: A Randomized, Controlled 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.
Read more
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).
Read the detailed description
The investigators will conduct a randomized controlled trial to evaluate the efficacy of a physical therapy intervention to improve motor function and reduce the severity of motor delays in infants admitted to the Neonatal Intensive Care Unit (NICU). The intervention is based on five principles: active learning, caregiver engagement, environmental enrichment, strengths-based approach, and dose. After enrollment, infants will be randomized to an intervention group or a standard of care group.
The intervention will start as early as possible (in the NICU) and continue until 12-months corrected age. Infants in the intervention group will receive up to two therapist visits per week in addition to standard of care physical therapy. Caregivers will be asked to work with their infant on activities provided by the therapist. The therapist will provide resources to support the caregiver in working on these activities with their child, and caregivers will be asked to complete the activities for as much time as possible, throughout the day. Therapists will work with caregivers to identify ways to incorporate activities into their day.
All infants in the study will be eligible to receive any services recommended or prescribed by their medical team and all families will be able to seek out and receive therapy or medical services outside of the study, without limitation.
All enrolled participants, regardless of group allocation, will complete sets of assessments at defined time points up to 12-months corrected age, with optional assessments at 18 and 24-months corrected age. The investigators will also ask all caregivers to complete surveys at defined time-points throughout the study to collect participant updates, information on infant development, and to monitor services received, caregiver engagement, and caregiver well-being. Caregivers may be invited to participate in a focus group and/or semi-structured interviews to evaluate study perceptions. Medical record review will be completed to evaluate standard-of-care services and medical history (as available).
- Conditions
- Motor Delay, Premature Birth, Intraventricular Hemorrhage, Hypoxic-Ischemic Encephalopathy, Bronchopulmonary Dysplasia
- Being tested
- Physical Therapy intervention
- Medical subject headings
- Psychomotor Disorders, Premature Birth, Hypoxia-Ischemia, Brain, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy interventionOther
The intervention is based on five principles: active learning, caregiver engagement, environmental enrichment, strengths-based approach, and dose. The intervention will start in the NICU and continue until 12-months corrected age. Infants in the intervention group will receive up to two therapist visits per week in addition to standard of care physical therapy. Caregivers will be asked to work with their infant on activities provided by the therapist. The therapist will provide resources to support the caregiver in working on these activities with their child, and caregivers will be asked to complete the activities for as much time as possible, throughout the day. Therapists will work with caregivers to identify ways to incorporate activities into their day. Caregiver engagement and caregiver ability to complete sessions and activity recommendations will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy Intervention | Experimental | Infants enrolled in this arm will receive the intervention in addition to standard of care Receives: Other: Physical Therapy intervention |
| Standard of Care | No intervention | Infants enrolled in this arm will receive standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley-4 motor score at 12-months corrected age
The Bayley-4 is an individually administered instrument that assesses the developmental functioning of infants and young children, aged between 16 days and 42 months, by observing the child's interaction with stimuli designed to engage them. It assesses five domains: Motor, Cognitive, Language, Social-emotional, and Adaptive behavior. The primary outcome will be the Bayley-4 motor score at 12-months corrected age. The standard scores range from 45-155 for the motor domain. Higher scores indicate better outcomes.
Measured: Bayley-4 motor score assessed at 12-months CA will be the primary outcome
Secondary outcomes (3)
Movement quality assessed by wearable sensors
Wireless, lightweight sensors that record continuous, real-time movement information will be applied to the infant's limbs, head, and upper torso at standardized locations either before, during, or after motor assessments. Up to 10 sensors will be applied. The infant's movements will be recorded in various postures, as appropriate to the age/abilities of the infant, such as: supine, prone, pull-to-sit/sitting, standing, and ventral suspension.
Measured: 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).
Pediatric Quality of Life Inventory (PedsQL)
This 36-item module measures parent self-reported functioning in physical (6 items), emotional (5 items), social (4 items), and cognitive (5 items) domains, communication (3 items), and worry (5 items), as well as two scales measuring parent-reported family functioning: daily activities (3 items) and family relationships (5 items). Items are reverse-scored and linearly transformed to a 0-100 scale, such that the minimum score is 0 and the maximum score is 100. A higher score indicates better quality of life.
Measured: PedsQL will be completed once during NICU stay (up to 45 days post enrolment), at one-and two-month intervals after enrollment; at 3-month corrected age (CA), 6-months CA, 9-months CA, 12-months CA, 18-months CA (optional), and 24-months CA (optional).
Bayley-4 Cognitive score Bayley-4 Cognitive score Bayley-4 Cognitive score
The cognitive section is part of a larger assessment that also covers language and motor skills. It is commonly used to determine developmental delays in children aged between 16 days and 42 months. The standard scores range from 45-155 for the motor domain. Higher scores indicate better outcomes.
Measured: The Bayley-4 cognitive score will be assessed at 6-months corrected age (CA), 12-months CA, 18-months CA (optional), and 24-months CA (optional).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Oct 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motor DelayStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stratified randomized block design, two-arm, parallel assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago, Northwestern University, Northwestern Medicine, University of Illinois Chicago
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
- Investigators
- Arun Jayaraman, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568264
- Sponsor's protocol ID
- IRB 2022 5243
- Status last verified
- Jul 2026
- First submitted
- 27 Sep 2022
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deng W, Anastasopoulos S, deRegnier RA, Pouppirt N, Barlow AK, Patrick C, O'Brien MK, Babula S, Sukal-Moulton T, Peyton C, Morgan C, Rogers JA, Lieber RL, Jayaraman A. Protocol for a randomized controlled trial to evaluate a year-long (NICU-to-home) evidence-based, high dose physical therapy intervention in infants at risk of neuromotor delay. PLoS One. 2023 Sep 19;18(9):e0291408. doi: 10.1371/journal.pone.0291408. eCollection 2023.
PubMed 37725613
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Therapeutic Improvement of Motor Delay in High Risk Infants: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05568264
- Acronym / sponsor ID
- IRB 2022 5243
- Conditions
- Motor Delay, Premature Birth, Intraventricular Hemorrhage, Hypoxic-Ischemic Encephalopathy, Bronchopulmonary Dysplasia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago, Northwestern University, Northwestern Medicine, University of Illinois Chicago
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The investigators will conduct a randomized controlled trial to evaluate the efficacy of a physical therapy intervention to improve motor function and reduce the severity of motor delays in infants admitted to the Neonatal Intensive Care Unit (NICU). The intervention is based on five principles: active learning, caregiver engagement, environmental enrichment, strengths-based approach, and dose. After enrollment, infants will be randomized to an intervention group or a standard of care group.
The intervention will start as early as possible (in the NICU) and continue until 12-months corrected age. Infants in the intervention group will receive up to two therapist visits per week in addition to standard of care physical therapy. Caregivers will be asked to work with their infant on activities provided by the therapist. The therapist will provide resources to support the caregiver in working on these activities with their child, and caregivers will be asked to complete the activities for as much time as possible, throughout the day. Therapists will work with caregivers to identify ways to incorporate activities into their day.
All infants in the study will be eligible to receive any services recommended or prescribed by their medical team and all families will be able to seek out and receive therapy or medical services outside of the study, without limitation.
All enrolled participants, regardless of group allocation, will complete sets of assessments at defined time points up to 12-months corrected age, with optional assessments at 18 and 24-months corrected age. The investigators will also ask all caregivers to complete surveys at defined time-points throughout the study to collect participant updates, information on infant development, and to monitor services received, caregiver engagement, and caregiver well-being. Caregivers may be invited to participate in a focus group and/or semi-structured interviews to evaluate study perceptions. Medical record review will be completed to evaluate standard-of-care services and medical history (as available).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stratified randomized block design, two-arm, parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy Intervention | Experimental | Other: Physical Therapy interventionInfants enrolled in this arm will receive the intervention in addition to standard of care |
| Standard of Care | No intervention | –Infants enrolled in this arm will receive standard of care |
Who may qualify
- Ages
- 33 to 48 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- NICU admission and qualifies for Early Childhood Clinic (NICU high-risk follow up clinic) or Early Intervention due to:
- BW <1500 grams
- OR
- Disorders of the central nervous system
- OR
Key exclusion criteria (13 listed)
- (related to inability to complete intervention, sensor placement, or clinic assessments)
- open wounds, skin condition precluding sensor placement
- immune deficiencies requiring protective isolation
- limb reduction defects
- followed primarily in another clinic (including but not limited to meningomyelocele and related conditions/trisomy 21)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Therapy interventionThe intervention is based on five principles: active learning, caregiver engagement, environmental enrichment, strengths-based approach, and dose. The intervention will start in the NICU and continue until 12-months corrected age. Infants in the intervention group will receive up to two therapist visits per week in addition to standard of care physical therapy. Caregivers will be asked to work with their infant on activities provided by the therapist. The therapist will provide resources to support the caregiver in working on these activities with their child, and caregivers will be asked to complete the activities for as much time as possible, throughout the day. Therapists will work with caregivers to identify ways to incorporate activities into their day. Caregiver engagement and caregiver ability to complete sessions and activity recommendations will be monitored. | Other | Physical Therapy Intervention |
Primary outcome
Bayley-4 motor score at 12-months corrected age
Time frame: Bayley-4 motor score assessed at 12-months CA will be the primary outcome
The Bayley-4 is an individually administered instrument that assesses the developmental functioning of infants and young children, aged between 16 days and 42 months, by observing the child's interaction with stimuli designed to engage them. It assesses five domains: Motor, Cognitive, Language, Social-emotional, and Adaptive behavior. The primary outcome will be the Bayley-4 motor score at 12-months corrected age. The standard scores range from 45-155 for the motor domain. Higher scores indicate better outcomes.
3 secondary outcomes
Movement quality assessed by wearable sensors
Time frame: 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).
Pediatric Quality of Life Inventory (PedsQL)
Time frame: PedsQL will be completed once during NICU stay (up to 45 days post enrolment), at one-and two-month intervals after enrollment; at 3-month corrected age (CA), 6-months CA, 9-months CA, 12-months CA, 18-months CA (optional), and 24-months CA (optional).
Bayley-4 Cognitive score Bayley-4 Cognitive score Bayley-4 Cognitive score
Time frame: The Bayley-4 cognitive score will be assessed at 6-months corrected age (CA), 12-months CA, 18-months CA (optional), and 24-months CA (optional).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Derived from this study: PubMed 37725613Deng W, Anastasopoulos S, deRegnier RA, Pouppirt N, Barlow AK, Patrick C, O'Brien MK, Babula S, Sukal-Moulton T, Peyton C, Morgan C, Rogers JA, Lieber RL, Jayaraman A. Protocol for a randomized controlled trial to evaluate a year-long (NICU-to-home) evidence-based, high dose physical therapy intervention in infants at risk of neuromotor delay. PLoS One. 2023 Sep 19;18(9):e0291408. doi: 10.1371/journal.pone.0291408. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Jayaraman, PT, PhD principal investigator
Shirley Ryan AbilityLab
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy intervention in people with Motor Delay and Premature Birth, run by Shirley Ryan AbilityLab at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley-4 motor score at 12-months corrected age (time frame: Bayley-4 motor score assessed at 12-months CA will be the primary outcome). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05568264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.