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Completed

NCT Number: NCT07068386

Telerehabilitation for Preterm Infants

The aim of this study is to investigate the feasibility and short-term effectiveness of early intervention delivered via telerehabilitation on the gross motor development of preterm infants.

The motor development of preterm infants will be assessed through video recordings. Based on these assessments and in collaboration with the parents, an intervention program will be developed. The parents will implement this intervention with their infants over a three-month period. Following this, motor development will be reassessed via video recordings.

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Key information

Conditions

Early Intervention Female Urogenital Diseases and Pregnancy Complications Infant, Premature Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Telerehabilitation Urogenital Diseases

Age range

3 month–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe Üniversitesi

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between November 2021 and May 2024, all preterm infants with a corrected age of 3 to 5 months who were referred to the our Department were invited to participate in the study.

Exclusion criteria

  • Infants with genetic abnormalities, hospitalized infants, those with blindness or deafness, infants requiring respiratory support, and physiologically unstable infants were excluded from the study.
  • Additionally, infants whose parents did not have the required technological equipment for telerehabilitation (mobile phone) or the skills to use it were not included in the study.
  • Children with optimal MOS-R were excluded from the study

Treatment and study plan

Early intervention with telerehabilitation

Other

All premature infants aged 3 to 5 months included in the study were assessed for motor development using the General Movements Assessment (GMs) and the Alberta Infant Motor Scale (AIMS), based on videos submitted by their parents. Following the video evaluations, parents were contacted via video call. An intervention program was developed in collaboration with the parents, guided by the video-based assessments.

The intervention program focused on the acquisition of age-appropriate motor development and included components such as massage, positioning, trunk control, movement selectivity, and anti-gravity activities. It was delivered to parents through synchronous. Parents were advised to implement the program for 30 minutes per day, 4 days a week, over a 12-week period. After the intervention, the infants were re-evaluated using the AIMS via video call.

Primary outcomes

  1. Motor Optimality Score-Revised (MOS-R) - A numerical result is obtained by observing the spontaneous motor movements, movement pattern, age adequate movement repertoire, postural patterns and movement character of infants.

    Time frame: MOS-R will be administered on Day 1 (baseline). If the baseline MOS-R score is ≤14, the MOS-R will be repeated on Days 8, 15, 22, and 29. If the score is greater than 14, no further MOS-R assessments will be performed.

    The infant's spontaneous motor movements in the fidgety period (corrected 3-5 months) are recorded on video for 3-5 minutes. The infant must be active and awake, and no external stimuli should be provided. The MOS-R is made with Gestalt perception on this recording.

    MOS-R consists of the sum of five subcategories. Spontaneous motor movements (normal=12, abnormal=4, absent=1 point), movement pattern (normal>abnormal=4, normal=abnormal=2 point, normal<abnormal=1 point), age adequate movement repertoire (present=4, reduced=2, absent=1 point), postural patterns (normal>abnormal=4, normal=abnormal=2, normal<abnormal= 1 point) and movement character (smooth and fluent=4, abnormal=2, cramped synchronized=1 point) The MOS-R ranges from 5 to 28, with higher scores indicating better outcomes. A score between 25 and 28 is considered optimal, 20 to 24 is mildly reduced, 9 to 19 is moderately reduced, and 5 to 8 is severely reduced.

  2. Alberta Infant Motor Scale (AIMS) - A numerical value is obtained by observing the child's gross motor development in the prone, supine, sitting and standing positions.

    Time frame: AIMS will be administered twice: once at baseline (Day 1) and once 13 weeks after baseline.

    It is a norm-referenced tool that evaluates the gross motor development of infants between 0-18 months. This tool evaluates weight transfer, posture and movement against gravity in prone, supine, sitting and standing positions.

    The infant receives a score between 0 and 58, depending on age. This score is then converted to a percentile. A higher percentile mean a better outcome.

Other outcomes

  1. Characteristics of infants and mothers

    Time frame: It will be recorded at study baseline.

    Gestational age (week)

  2. Characteristics of infants and mothers

    Time frame: It will be recorded at study baseline.

    Birth weight (gram)

  3. Characteristics of infants and mothers

    Time frame: It will be recorded at study baseline.

    Gender (female/male)

  4. Characteristics of infants and mothers

    Time frame: It will be recorded at study baseline.

    Multiple pregnancy (single/twin)

  5. Characteristics of infants and mothers

    Time frame: It will be recorded at study baseline.

    Maternal age (year)

  6. Characteristics of infants and mothers

    Time frame: It will be recorded at study baseline.

    Maternal education (primary/high/higher school)

  7. Characteristics of infants and mothers

    Time frame: It will be recorded at study baseline.

    Number of siblings (number)

  8. Characteristics of infants and mothers

    Time frame: It will be recorded at study baseline.

    Duration of hospital (day)

  9. Characteristics of infants and mothers

    Time frame: It will be recorded at study baseline.

    Respiratuar distress syndrome (yes/no)

  10. Characteristics of infants and mothers

    Time frame: It will be recorded at study baseline.

    Preeclampsia (yes/no)

  11. Characteristics of infants and mothers

    Time frame: It will be recorded at study baseline.

    Seizure (yes/no)

  12. Characteristics of infants and mothers

    Time frame: It will be recorded at study baseline.

    Intracranial hemorrhage (yes/no)

  13. Characteristics of infants and mothers

    Time frame: It will be recorded at study baseline.

    Retinopathy of prematurity (yes/no)

  14. Characteristics of infants and mothers

    Time frame: It will be recorded at study baseline.

    Economic status (low/moderate/high)

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Implementation of Telerehabilitation Includes Neuromotor Assessment and Early Intervention for Preterm Infants

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Jul 16, 2025
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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