Telerehabilitation for Preterm Infants

NCT07068386 | Completed

• 1 other identifier: 2021/219
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Intervention; Infant, Premature; Telerehabilitation

Keywords

Early intervention; infant; premature; telerehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

• 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.

  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.

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

Other Outcomes (14)

• Characteristics of infants and mothers

  It will be recorded at study baseline.

• Characteristics of infants and mothers

  It will be recorded at study baseline.

• Characteristics of infants and mothers

  It will be recorded at study baseline.

Study Arms (1)

Infant

EXPERIMENTAL

The study was conducted using a single-arm design to investigate the feasibility and short-term effectiveness of early intervention delivered via telerehabilitation on the gross motor development of preterm infants. The intervention was individualized for each infant, based on principles of typical motor development, motor learning, and environmental enrichment

Other: Early intervention with telerehabilitation

Interventions

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.

Infant

Eligibility Criteria

• Age: 3 Months - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe Üniversitesi

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• Schlichting T, Martins da Silva K, Silva Moreira R, Marques de Moraes MV, Cicuto Ferreira Rocha NA, Boyd RN, Neves Dos Santos A. Telehealth Program for Infants at Risk of Cerebral Palsy during the Covid-19 Pandemic: A Pre-post Feasibility Experimental Study. Phys Occup Ther Pediatr. 2022;42(5):490-509. doi: 10.1080/01942638.2022.2057209. Epub 2022 Mar 27.

  PMID: 35341469 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Early Intervention, Educational; Telerehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Ph.D.)

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: July 16, 2025
• Study Start: November 20, 2021
• Primary Completion: November 15, 2022
• Study Completion: February 1, 2024
• Last Updated: July 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)