Infants Admitted to Neonatal UnitsNCT07201805
Effects of Early Physiotherapy on Motor Optimality Score in At-Risk of Infants
A study testing Early Physiotherapy Program in people with Infants Admitted to Neonatal Units and Preterm, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Medical and technological advances in neonatal care have led to a decrease in neonatal mortality and an increase in the survival of very low birth weight infants, leading to a global increase in the prevalence of cerebral palsy (CP), cardiorespiratory disorders, blindness, cognitive delays, and hearing impairments. Read more about this study
- Who is it for?
- Ages 2 to 5 months
- Conditions the study is for
- Infants Admitted to Neonatal Units, Preterm, Physiotherapy and Rehabilitation
- What is being tested?
- Early Physiotherapy Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 30 Oct 2026
- 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 2 to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants diagnosed with periventricular hemorrhage (PVH), intracranial hemorrhage (ICH), cystic PVL, HIE, kernicterus, perinatal asphyxia, neonatal sepsis, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), RDS, or BPD, and those receiving oxygen or mechanical ventilation (MV) support
- Infants with a 5-minute Apgar score <3, <37 weeks' gestation, <1500 grams of preterm birth, or prematurity due to multiple births.
- Infants with the corrected age of 2 to 4 months
Who cannot join
- Infants with congenital malformations (spina bifida, congenital muscular torticollis, arthrogryposis multiplex congenita, etc.), babies diagnosed with metabolic and genetic diseases (down syndrome, spinal muscular atrophy, duchenne muscular dystrophy, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kahramanmaraş Sütçü imam University
Kahramanmaraş, Onikişubet, 46100
05056491048
About this study
Official title: Effects of Early Physiotherapy on Motor Optimality Score in At-Risk of Infants: A Double-Blind Randomized Controlled Study
Medical and technological advances in neonatal care have led to a decrease in neonatal mortality and an increase in the survival of very low birth weight infants, leading to a global increase in the prevalence of cerebral palsy (CP), cardiorespiratory disorders, blindness, cognitive delays, and hearing impairments. Early diagnosis and intervention programs have been established to meet the developmental needs of these at-risk infants in the neonatal intensive care unit (NICU). The goal of these programs is to facilitate the development of at-risk infants and normalize their motor, cognitive, and sensory development.Research remains unclear about which interventions are more effective when implemented. It is known that early intervention improves motor development in these infants, and that programs that include parents have more positive long-term outcomes for the cognitive and language development of at-risk infants.General Movements (GMs) are spontaneous movements that occur from the fetal period to 18 weeks postterm. Prechtl's General Movements Assessment (GMA) is a reliable tool for functional assessment of the young central nervous system.The assessment of motor repertoire (via the motor optimality score, MOS) describes the quality and quantity of the concurrent motor repertoire recorded during the GM assessment.The revised motor optimality score (MOS-R) has the potential to increase the prediction of adverse neurodevelopmental outcomes. It is noteworthy that the literature contains limited studies examining the effect of early physiotherapy applied to at-risk infants after NICU discharge on MOS-R. Therefore, the aim of this planned study was to investigate the effect of early family collaborative physiotherapy approaches applied to at-risk infants after NICU discharge on GMs MOS-R. Another aim was to determine the effect of early physiotherapy on neurological examination, cognitive, and language development in infants at 3 and 6 months of age and to compare them with similar peers receiving a routine treatment protocol.
- Conditions
- Infants Admitted to Neonatal Units, Preterm, Physiotherapy and Rehabilitation, Family Centered
- Being tested
- Early Physiotherapy Program, Control group
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Physiotherapy ProgramOther
The physiotherapy program provided upon discharge will consist of family education programs that include parental contact and therapeutic holding, carrying, positioning, and sucking facilitation to stimulate postural responses. The physiotherapist will provide training to integrate these programs into daily routines. The physiotherapy group will receive a routine-based family collaborative early intervention program. This program will consist of family education programs based on a goal-oriented model of active motor learning and sensory strategy development for the baby in an enriched environment, incorporating holding, carrying, and positioning into daily routines. If possible, the entire family will participate in these programs.
Control groupOther
The control group will be shown one-time positioning and holding and carrying principles in addition to routine developmental NICU care at the time of discharge.
| Study group | Role | What they receive |
|---|---|---|
| Early Physiotherapy Program | Experimental | A physiotherapy program tailored to the needs of infants from families who volunteer to participate will be implemented until and with family recommendations at the time of discharge. Parents of all at-risk infants will receive advice on handling, carrying, and positioning at the time of discharge. Receives: Other: Early Physiotherapy Program |
| Standard of care | Other | Babies from families unable to attend physiotherapy for any reason (working parents, those unable to attend treatment sessions, or those living out of town) will constitute the control group, provided they are available for evaluation. The control group will receive routine developmental NICU care, as well as one-time instruction in positioning and holding and carrying principles upon discharge. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Optimality Score for 3-to 5-Month-Old Infants - Revised and Motor Repertoire Score
All babies will have their Motor Optimality Scores (MOS-R) calculated at the end of the 4th and 5th months, adjusted for fidgety General Movements of the videos. The MOS-R assesses movement repertoire and scores in the following four areas.The total of these scores varies between 5 and 28. Higher scores shows better developmental status.
Measured: postterm 12th to 20 weeks of age
Pretchl's General Movements (GMs) Assesment
General movements (GMs) are the spontaneous repertoire of movements present from early fetal life until the 20th week postpartum. They are writhing until the 8th week postpartum and then fidgety until approximately the 20th week.Video recordings will begin in the NICU three days after birth in the preterm period. All infants will be examined for writhing and fidgety movements (FM) via video recordings.Movements during the preterm and writhing periods will be classified as PR, CS, and Ch GMs or normal. Movements during the fidgety period will be recorded as F+ or F++ when normal, AF when abnormal, or F- when not observed.
Measured: after the postterm 8th weeks of age and after the postterm weeks of 12 to 20 weeks
Secondary outcomes (4)
Hammersmith Neonatal Neurological Examination (HNNE)
This measurement has been developed by Dubowitz, the examination standardized optimality scores by evaluating low-risk term and high-risk preterm infants at term age. The scale consists of a 34-item proforma. This proforma includes tone (10), tone patterns (5), reflexes (6), movements (3), abnormal signs (3), and behavior (7). All items are scored from 1 to 3 (half points are also possible). Higher scores indicate better neurological status.
Measured: from birth to 42 weeks of age
Hammersmith Infant Neurological Examination (HINE)
The Hammersmith Infant Neurological Examination (HINE) is a simple, standardized, and scoreable test for the clinical neurological assessment of infants aged 2-24 months. HINE consists of a total of 37 items, divided into three sections: neurological examination, developmental motor milestones, and behavioral status.It consists of three sections: (1) a neurological examination that assesses cranial nerve function, posture, movements, tone, reflexes, and reactions; (2) motor milestones; and (3) behavior. Each of the 26 items on the test is initially scored individually (0, 1, 2, 3, or half points). A total score is then calculated, with miimum score of 37 and a maximum score of 78 points.A higher score indicates better neurological status.
Measured: 2th, 3th, 6th months of corrected age
BAYLEY-III Infant and Child Development Assessment Scale (BAYLEY-III)
The BAYLEY-III Infant and Child Development Assessment Scale (BAYLEY-III ) is a neurocognitive assessment used to monitor the development of infants aged 0-42 months. It comprises five domains: cognitive, language, motor, social-emotional, and adaptive functions. This study will assess only the cognitive, language, and motor domains.To ensure comparability of results from the 5 domains, a composite score is calculated for each domain (mean 100±15). A composite score below 2 standard deviations (SD) (<70) is considered a severe delay across all domains.Higher scores give better developmental stages.
Measured: 3th and 6th months of corrected age
Sociodemographic form
Sociodemographic information and prenatal/perinatal risks (MRI, cUS results, diagnosis, neurological evaluation) of all infants and their parents will be obtained from hospital records after treatment.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Sep 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infants Admitted to Neonatal UnitsStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Adiguzel, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201805
- Sponsor's protocol ID
- Early PT on Motor Optimality
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Physiotherapy on Motor Optimality Score in At-Risk of Infants: A Double-Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07201805
- Acronym / sponsor ID
- Early PT on Motor Optimality
- Conditions
- Infants Admitted to Neonatal Units, Preterm, Physiotherapy and Rehabilitation, Family Centered
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 1 Oct 2025 (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.
Medical and technological advances in neonatal care have led to a decrease in neonatal mortality and an increase in the survival of very low birth weight infants, leading to a global increase in the prevalence of cerebral palsy (CP), cardiorespiratory disorders, blindness, cognitive delays, and hearing impairments. Early diagnosis and intervention programs have been established to meet the developmental needs of these at-risk infants in the neonatal intensive care unit (NICU). The goal of these programs is to facilitate the development of at-risk infants and normalize their motor, cognitive, and sensory development.Research remains unclear about which interventions are more effective when implemented. It is known that early intervention improves motor development in these infants, and that programs that include parents have more positive long-term outcomes for the cognitive and language development of at-risk infants.General Movements (GMs) are spontaneous movements that occur from the fetal period to 18 weeks postterm. Prechtl's General Movements Assessment (GMA) is a reliable tool for functional assessment of the young central nervous system.The assessment of motor repertoire (via the motor optimality score, MOS) describes the quality and quantity of the concurrent motor repertoire recorded during the GM assessment.The revised motor optimality score (MOS-R) has the potential to increase the prediction of adverse neurodevelopmental outcomes. It is noteworthy that the literature contains limited studies examining the effect of early physiotherapy applied to at-risk infants after NICU discharge on MOS-R. Therefore, the aim of this planned study was to investigate the effect of early family collaborative physiotherapy approaches applied to at-risk infants after NICU discharge on GMs MOS-R. Another aim was to determine the effect of early physiotherapy on neurological examination, cognitive, and language development in infants at 3 and 6 months of age and to compare them with similar peers receiving a routine treatment protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Physiotherapy Program | Experimental | Other: Early Physiotherapy ProgramA physiotherapy program tailored to the needs of infants from families who volunteer to participate will be implemented until and with family recommendations at the time of discharge. Parents of all at-risk infants will receive advice on handling, carrying, and positioning at the time of discharge. |
| Standard of care | Other | Other: Control groupBabies from families unable to attend physiotherapy for any reason (working parents, those unable to attend treatment sessions, or those living out of town) will constitute the control group, provided they are available for evaluation. The control group will receive routine developmental NICU care, as well as one-time instruction in positioning and holding and carrying principles upon discharge. |
Who may qualify
- Ages
- 2 to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants diagnosed with periventricular hemorrhage (PVH), intracranial hemorrhage (ICH), cystic PVL, HIE, kernicterus, perinatal asphyxia, neonatal sepsis, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), RDS, or BPD, and those receiving oxygen or mechanical ventilation (MV) support
- Infants with a 5-minute Apgar score <3, <37 weeks' gestation, <1500 grams of preterm birth, or prematurity due to multiple births.
- Infants with the corrected age of 2 to 4 months
Key exclusion criteria (1 listed)
- Infants with congenital malformations (spina bifida, congenital muscular torticollis, arthrogryposis multiplex congenita, etc.), babies diagnosed with metabolic and genetic diseases (down syndrome, spinal muscular atrophy, duchenne muscular dystrophy, etc.)
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 |
|---|---|---|
| Early Physiotherapy ProgramThe physiotherapy program provided upon discharge will consist of family education programs that include parental contact and therapeutic holding, carrying, positioning, and sucking facilitation to stimulate postural responses. The physiotherapist will provide training to integrate these programs into daily routines. The physiotherapy group will receive a routine-based family collaborative early intervention program. This program will consist of family education programs based on a goal-oriented model of active motor learning and sensory strategy development for the baby in an enriched environment, incorporating holding, carrying, and positioning into daily routines. If possible, the entire family will participate in these programs. | Other | Early Physiotherapy Program |
| Control groupThe control group will be shown one-time positioning and holding and carrying principles in addition to routine developmental NICU care at the time of discharge. | Other | Standard of care |
Primary outcome
Motor Optimality Score for 3-to 5-Month-Old Infants - Revised and Motor Repertoire Score
Time frame: postterm 12th to 20 weeks of age
All babies will have their Motor Optimality Scores (MOS-R) calculated at the end of the 4th and 5th months, adjusted for fidgety General Movements of the videos. The MOS-R assesses movement repertoire and scores in the following four areas.The total of these scores varies between 5 and 28. Higher scores shows better developmental status.
Pretchl's General Movements (GMs) Assesment
Time frame: after the postterm 8th weeks of age and after the postterm weeks of 12 to 20 weeks
General movements (GMs) are the spontaneous repertoire of movements present from early fetal life until the 20th week postpartum. They are writhing until the 8th week postpartum and then fidgety until approximately the 20th week.Video recordings will begin in the NICU three days after birth in the preterm period. All infants will be examined for writhing and fidgety movements (FM) via video recordings.Movements during the preterm and writhing periods will be classified as PR, CS, and Ch GMs or normal. Movements during the fidgety period will be recorded as F+ or F++ when normal, AF when abnormal, or F- when not observed.
4 secondary outcomes
Hammersmith Neonatal Neurological Examination (HNNE)
Time frame: from birth to 42 weeks of age
Hammersmith Infant Neurological Examination (HINE)
Time frame: 2th, 3th, 6th months of corrected age
BAYLEY-III Infant and Child Development Assessment Scale (BAYLEY-III)
Time frame: 3th and 6th months of corrected age
Sociodemographic form
Time frame: baseline
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 1 Oct 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Physiotherapy Program in people with Infants Admitted to Neonatal Units and Preterm, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Contact hatice adıgüzel tat, Associate Proffessor (+903443002647, fzthatis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Optimality Score for 3-to 5-Month-Old Infants - Revised and Motor Repertoire Score (time frame: postterm 12th to 20 weeks of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.