Developing and testing a Structured Early Physiotherapy Intervention for Babies Born Moderate to Late Preterm to Promote their Neuromotor Development

Development and Validation of STructured Early Physiotherapy (Preemie STEP) Intervention on Neuromotor Development in Moderate to Late Preterm Infants - Preemie STEP

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060853

Enrollment

Registered

2023-12-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Structured Early Physiotherapy Intervention for Preterm Infants (Preemie STEP): An early developmental intervention that combines movement imitation therapy with a parent-mediated home

Eligibility

Inclusion criteria

Inclusion criteria: 1. Preterm infants born between 32-week 0/7 days to 36-week 6/7 days GA MLP infants with birth weight less than 2. Medically stable infants admitted to the Low dependency Unit of NICU 3. Parents/caregivers able to understand/speak Kannada or English 4. Parents/caregivers willing to participate & who have informed consent

Exclusion criteria

Exclusion criteria: 1. MLP infants with birth weight of more than >2500 grams 2. Infants with genetic/chromosomal disorders 3. Severe congenital anomalies 4. Infants with any neurological/musculoskeletal insult during the follow-up period

Design outcomes

Primary

Measure	Time frame
1. Prechtl’s General Movement Assessment (GMA) 2.Test in Infant Motor Performance (TIMP)Timepoint: 1. Prechtl’s General Movement Assessment (GMA) 2.Test in Infant Motor Performance (TIMP)	—

Secondary

Measure	Time frame
1. Hammersmith Infant Neurological Scale (HINE) 2. Bayley Scale of Infant & Toddler Development – 3rd edition (BSID-III) 3. Parental experiences – a questionnaire to evaluate infant participation & the usability of the deviceTimepoint: At 3 and 6 months follow-up	—

Countries

India

Contacts

Public ContactDr Sivakumar G

Manipal College of Health Professions, Manipal Academy Higher Education

bhamini.kr@manipal.edu9480267152

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026