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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Physiotherapy of At-Risk Infants, Physiotherapist or Family?

NCT02681289

Problem With Growth of an Infant

COMPLETED NA

Effectiveness of Family Collaborative Physiotherapy Programs With High-risk Infants

NCT04035291

Cerebral Palsy Infant, Newborn, Disease Infant, Small for Gestational Age +5 more

COMPLETED NA

The Effect of Inspiratory Muscle Training on Functional Gain in Cerebral Palsy: A Randomised Controlled Trial

NCT07041593

Cerebral Palsy Respiratory Muscle Training Dysphagia +3 more

COMPLETED NA

A Survey of Turkish Pediatric Physical Therapists

NCT07180017

Cerebral Palsy (CP) Survey Detection +1 more

COMPLETED

The Effect Of Somatosensory Perceptıon And Proprıoceptıon On Upper Extremıty Functıonal Skılls

NCT05213715

Cerebral Palsy Somatosensory Disorders Upper Extremity Dysfunction +1 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infants Admitted to Neonatal Units Preterm Physiotherapy and Rehabilitation Family Centered

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early Physiotherapy Program

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.

Group Type EXPERIMENTAL

Early Physiotherapy Program

Intervention Type 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.

Standard of care

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.

Group Type OTHER

Control group

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Early Physiotherapy Program

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.

Intervention Type OTHER

Control group

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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.)

Minimum Eligible Age

2 Months

Maximum Eligible Age

5 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No