HEP® Tele-Rehabilitation for Preterm Infants at Developmental Risk: A Feasibility Study

NCT07727720 | Completed

• 1 other identifier: E-10840098-202.3.02-736
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Several early intervention approaches based on sensory and motor environmental enrichment have demonstrated neurobehavioral benefits and improvements in motor and cognitive skills in infants. Tele-rehabilitation has also been shown to positively impact the motor and cognitive development of at-risk infants. However, limited research has examined the effects of environmental enrichment-based early interventions delivered via tele-rehabilitation on sensory, motor, cognitive, language, and socio-emotional skills, adaptive behaviors, parental goals, and parental anxiety in preterm infants at developmental risk, as well as the feasibility of delivering such interventions online. The proposed study aims to evaluate the effects of the environmental enrichment-based HEP® approach delivered through tele-rehabilitation on these developmental outcomes in preterm infants, thereby contributing to the existing literature.

Conditions

Preterm

Keywords

Tele-rehabilitation

Outcome Measures

Primary Outcomes (7)

• The Infant Motor Profile (IMP)

  The IMP is a method designed to evaluate the motor behaviour of infants aged 3 to 18 months CA. The IMP is based on a video recording of a semi-standardized play session of about 15 minutes, during which an assessor plays with the infant in such a way that the IMP items can be assessed. This means that the playing assessor has knowledge of the IMP items, allowing her to adapt the assessment to the infant's functional abilities and the IMP needs. The 80 items of the IMP evaluate motor behaviour in supine and prone positions; while sitting, standing, and walking; when reaching and grasping; and during manipulation. It is a discriminative, evaluative, and predictive measurement. The IMP has been developed for health care professionals working in the feld of early detection of developmental disorders and early intervention.

  At baseline and immediately after the 12-week intervention.

• The Alberta Infant Motor Scale (AIMS)

  The Alberta Infant Motor Scale (AIMS) is a standardized assessment designed to evaluate motor development in infants. It specifically measures both fine and gross motor skills across a range of developmental stages. This assessment provides valuable information regarding infants' physical abilities and developmental progress. The test typically takes approximately 15 minutes to administer, and scores are interpreted by comparison with a normative database.

  At baseline and immediately after the 12-week intervention.

• Depression Anxiety Stress Scales-21 (DASS-21)

  The DASS-21 is a validated and reliable tool for screening depressive and anxiety disorders, and it effectively assesses the severity of three psychological states through 21 items. The scale consists of three subscales: depression (7 items), anxiety (7 items), and stress (7 items). Each item is rated on a 4-point Likert scale ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). Lower scores on the subscales indicate better psychological well-being.

  At baseline and immediately after the 12-week intervention.

• The Ages and Stages Questionnaires (ASQ)

  The ASQ is a developmental screening tool that enables parents to assess an infant's developmental progress. The questionnaire comprises three sections: demographic information, a 30-item developmental section, and seven open-ended questions. The 30-item section evaluates five developmental domains-communication, fine motor skills, gross motor skills, problem-solving, and personal-social development-each domain consisting of six questions.

  At baseline and immediately after the 12-week intervention.

• Ages and Stages Questionnaires: Social-Emotional (ASQ:SE)

  The ASQ:SE was developed as a complementary tool to the ASQ to assess social-emotional development and behavioral difficulties in infants. The questionnaire is completed by parents and evaluates key domains, including self-regulation, adaptability, communication, adaptive behavior, autonomy, emotional status, and interactions with

  At baseline and immediately after the 12-week intervention.

• Young Children's Participation and Environment Measure (YC-PEM)

  The YC-PEM is a parent-completed measure designed to assess the level and quality of participation of children aged 0-5 years in various activities and the environments in which these activities take place.

  At baseline and immediately after the 12-week intervention.

• The Goal Attainment Scale (GAS)

  The Goal Attainment Scale (GAS) is the most commonly recommended goal-setting methodology for measuring change during and after intervention in clinical and research applications. The GAS, which assesses the child's achievement of individual goals established with parents at the beginning of the intervention, is a reliable tool for children with developmental challenges and provides subjective information about the child's needs. The GAS has a rating scale of "-2" to "+2."

  At baseline and immediately after the 12-week intervention.

Study Arms (1)

HEP® Tele-Rehabilitation Intervention

EXPERIMENTAL

This arm includes infants receiving the HEP® (Homeostasis-Environmental Enrichment-Plasticity) approach, an early intervention program delivered entirely online through tele-rehabilitation. The intervention is conducted in 45-minute sessions over 12 weeks, following environmental enrichment principles. Parent training is provided to support the implementation of activities at home, and individualized developmental goals are established for each infant at the beginning of the intervention. All assessments and the intervention are conducted online.

Behavioral: HEP® Tele-Rehabilitation Intervention

Interventions

HEP® Tele-Rehabilitation Intervention BEHAVIORAL

This group receives the HEP® Tele-Rehabilitation Intervention, an early intervention program based on the Homeostasis-Environmental Enrichment-Plasticity approach and delivered entirely through tele-rehabilitation. The intervention consists of 45-minute online sessions conducted weekly over 12 weeks and follows environmental enrichment principles. Parent training is provided to support the implementation of activities in the home environment, and individualized developmental goals are established for each infant at the beginning of the intervention. All assessments and intervention procedures are conducted remotely via online platforms.

Also known as: Homeostasis-Environmental Enrichment-Plasticity Approach

HEP® Tele-Rehabilitation Intervention

Eligibility Criteria

• Age: 4 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants with a corrected age between 4 and 12 months.
• Infants born at or before 36 weeks and 6 days of gestation.
• Infants with no congenital anomalies.
• Families who agree to participate regularly in the study process.

You may not qualify if:

• Infants with major visual or hearing impairments.
• Infants with any genetic syndrome or congenital anomalies.
• Infants with medical conditions that prevent active participation in the study (e.g., oxygen dependence).
• Infants participating in other experimental rehabilitation studies.

Sponsors & Collaborators

• Izgi Miray Demirbag: lead

Study Sites (1)

Sense On

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Aymen Balıkcı, Dr. Physiotherapist

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The outcomes assessor who conducted the online evaluations of the infants was different from the therapist delivering the online intervention, ensuring that the assessment was independent of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist

Model Details: The study employed the HEP® (Homeostasis-Environmental Enrichment-Plasticity) approach, an early intervention method based on environmental enrichment and delivered through tele-rehabilitation. The HEP® approach is an ecological model designed to provide multidimensional support to infants at developmental risk during the early stages of development. It is grounded in a holistic integration of the biological foundations of development and environmental interactions. The intervention is structured around a theoretical framework that promotes physiological homeostasis, encourages exploration of the environment, and facilitates neuroplasticity. The HEP® approach aims to optimize the developmental potential of infants at risk for developmental difficulties through early, targeted environmental enrichment.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: July 27, 2026
• Study Start: November 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)