Effects of Early Physiotherapy on Motor Optimality Score in At-Risk of Infants

NCT07201805 | Recruiting

• 1 other identifier: Early PT on Motor Optimality
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  from birth to 42 weeks of age

• Hammersmith Infant Neurological Examination (HINE)

  2th, 3th, 6th months of corrected age

• BAYLEY-III Infant and Child Development Assessment Scale (BAYLEY-III)

  3th and 6th months of corrected age

• Sociodemographic form

  baseline

Study Arms (2)

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.

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.

Other: Control group

Interventions

Early Physiotherapy Program OTHER

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.

Early Physiotherapy Program

Control group OTHER

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.

Standard of care

Eligibility Criteria

• Age: 2 Months - 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaraş Sütçü imam University

Kahramanmaraş, Onikişubet, 46100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

hatice adıgüzel tat, Associate Proffessor

CONTACT

+903443002647; fzthatis@gmail.com

hatice Adiguzel tat, Associate Proffessor

CONTACT

+903443002647; fzthatis@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate profesor

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: October 1, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)