Protocol for development and validation of an Early Intervention device and its influence using STructured Early

Indira D B Naidu Boddapati1, Sivakumar Gopalakrishnan2,3, Sonia Khurana4

  • 1Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, India.

Methodsx
|August 14, 2025
PubMed

Insights

This study developed a home-based Early Intervention (EI) device to improve physiotherapy continuity for moderate to late preterm (MLP) infants. The Preemie STEP intervention, using this device, showed promise in supporting MLP infants post-discharge.

Area of Science:

  • Pediatrics
  • Rehabilitation Medicine
  • Biomedical Engineering

Background:

  • Physiotherapy continuity for moderate to late preterm (MLP) infants is challenging post-hospital discharge.
  • Existing early intervention (EI) programs often lack integrated home-based components.
  • There is a need for user-centered tools to support home physiotherapy for MLP infants.

Purpose of the Study:

  • To develop an Early Intervention (EI) device for home-based physiotherapy in MLP infants.
  • To evaluate the usability and validity of the developed EI device.
  • To determine the influence of the Structured Early Physiotherapy (Preemie STEP) intervention incorporating the EI device on MLP infants.

Main Methods:

  • Phase I: Qualitative interviews with healthcare professionals and parents for user needs assessment.
  • Human-centered design and iterative development of the EI device.
  • Phase II: Usability and validity testing of the EI device on 10 MLP infants.
  • Pilot Randomized Control Trial (RCT) with 24 MLP infants using the Preemie STEP intervention and EI device.
  • Intervention included Movement Imitation Therapy (MIT) in NICU and home program via EI device up to 6 months post-discharge.

Main Results:

  • Qualitative data informed the human-centered design of the EI device.
  • Usability and validity of the EI device were assessed in a small cohort.
  • A pilot RCT will provide preliminary data on the clinical effectiveness of the Preemie STEP intervention with the EI device.

Conclusions:

  • The developed EI device addresses user needs for home-based physiotherapy in MLP infants.
  • The Preemie STEP intervention, facilitated by the EI device, offers a potential solution for continuity of care.
  • Further research is warranted to confirm the clinical effectiveness and long-term benefits.

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