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

The study will be conducted in two phases.

In Phase I:

Objective 1A: To understand the perspectives of healthcare professionals and parents on indigenously developed early intervention device for preterm infants:

A thorough literature will be conducted on studies supporting healthcare professionals’ and parents   perceptions of an early home-based intervention program, and an interview guide will be developed according to the two domains (Healthcare Professionals and parents). The experts in the field will review and validate the interview guide. Further, a qualitative in-depth face-to-face interview will be conducted by PI in the participant’s preferred hospital environment after obtaining the written consent. The indigenously designed EI device & its components will be presented to the participant. Each interview will last between 30-45 minutes on average and opinions on the device’s development and user manuals/educational handouts will be addressed. The interview will be audio-recorded and converted to a text format for data analysis.

Objective 1B: To design and develop a home-based early intervention device for preterm infants

The needs and concepts will be identified based on the perspective of healthcare experts’ perspectives on the device’s development and will be discussed with the product design expert. The new generated concepts will be set for final specification for product development.

The EI device will be developed as a positional support to the infant to promote motor, and sensory development, play, and cognition through early stimulating activities. It will be made up of soft fabric materials, rexine, foam rolls, and Velcro-receptive material in designing the exercise mat, wedge, support rolls/bolsters and positional straps. • An exercise mat will be made to provide a safe and even surface for the child’s planned activities. • Support rolls will be made up of foam rolls, rexine, and soft fabric material that will be designed to provide safe and comfortable support while performing motor-stimulating activities in supine, side-lying, and prone positions. • The positioning bolsters (of various sizes) will be made from foam rolls, designed for user comfort in regard, with a primary focus on infant positioning to promote motor activities. • The above positioning components will be fastened to the mat using positional straps and Velcro-receptive materials. An iterative process of prototyping and testing will be conducted following the Human-Centered Approach design model to develop a home-based EI device for preterm infants. Subsequently, the initial content of the user manual will be designed with pictorial representation. The initial draft will be distributed to subject experts for content validation, and any modifications suggested by them will be made before the final version of the user manual is developed. The responses will be analyzed using the Content Validity Index (CVI) and Patient Education Materials Assessment Tool (PEEMAT).

In Phase II:

Objective 2A: To validate the usability of the designed home-based early intervention device on term and preterm infants.

The developed EI device with the user manual will be intended to be clinically validated on term infants first, and then on preterm infants. Parents/caregivers will be asked for informed consent for recruitment and will be educated and shown how to use the device on their infant to actively perform specified goal-directed activities outlined in the device user manual. The parent/caregiver will be given instructions for two weeks of activities to be performed at home with the EI device on the infant. Further, parents/caregivers (end-users) will be interviewed (a questionnaire will be designed and validated) to assess infant participation and parents’ experiences of the EI device’s usability. Validity testing will be performed on the Patient Education Materials Assessment Tool (PEEMAT).

Objective 2B: To pilot test the effect of STructured Early Physiotherapy Intervention (Preemie STEP) on Neuromotor Development in Moderate to Late preterm Infants

Infants will be screened for participation based on the inclusion criteria and written consent will be obtained from parents/caregivers. Participants will be randomized using sequentially numbered opaque sealed envelopes (SNOSE), which will be created according to a computer-generated random allocation order. With a 1:1 allocation ratio, block randomization with randomly variable block sizes ensures an equal number of participants in each group. At the time of enrollment, the infant’s perinatal and clinical data will be collected. At 34 weeks of gestation, the baseline evaluation will be performed using GMA and TIMP. A blinded assessor who is certified and trained in the outcome measures will conduct the evaluation. The control group will receive standard care (kangaroo mother care, positioning, and oil application) during the hospital stay and the parent/caregiver will be given an educational handout for the home program and instructed to continue routine medical care and usual traditional practices. The intervention group will receive Preemie STEP Intervention, an early developmental intervention that combines movement imitation therapy with a parent-mediated home program using an EI device to improve sensory-motor feedback and optimize motor repertoire. During the hospital stay, the infant will get movement imitation treatment 3 times/day for 10-15 minutes during their quiet alert state. The intervention will be administered with therapist-parent collaboration until hospital discharge, and it will be parent-mediated until the next hospital follow-up. The parent/caregiver will be educated on home-program activities outlined in the user manual using the EI device. The intervention will be scheduled 2 times/day, with a minimum of 4 to 5 hours break, with each treatment for 20-30 minutes during the infant’s quiet alert state. To maintain treatment compliance, a logbook will be provided to record the frequency, type, and duration of the exercise. At 3 months, the infant’s GMA, TIMP, HINE, and BSID-III will be assessed, and at 6 months, the infant’s HINE, BSID-III, and parent’s experiences will be assessed using a questionnaire about infants’ participation and parents’ opinion about EI device in delivering the intervention. Furthermore, a 7-point Global Perceived Effect (GPE) scale will be included at follow-up. The parent’s logbook will be evaluated to determine the acceptability and feasibility of the proposed intervention.