An interventional study of Synchronous Telerehabilitation Group and Asynchronous Telerehabilitation Group in Risky Baby, Premature Birth of Newborn and Motor Delay, sponsored by Biruni University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 6 Months to 9 Months. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Biruni University · Not applicable, Interventional, and Supportive care
Premature birth, low birth weight, and a history of neonatal intensive care history are significant risk factors associated with long-term neurodevelopmental adverse outcomes in infants. Family-centered early intervention programs play a critical role in minimizing the impact of these risks and optimizing developmental potential. Currently, telerehabilitation (TR) has emerged as a cost-effective solution that facilitates access to early intervention services. However, there is limited literature directly comparing the efficacy and feasibility of synchronous (real-time) and asynchronous (store-and-forward) parent coaching-based TR models specifically within the at-risk infant population.
The primary objective of this project is to comparatively examine the effects of synchronous and asynchronous TR programs on motor development levels, individualized goal attainment, and parental self-efficacy in infants aged 6-9 months (corrected age) at risk of developmental delay, against a standard home program (control group). Designed as a randomized controlled trial, the study will include 45 high-risk infants meeting the inclusion criteria, who will be randomly allocated into three groups: Synchronous TR, Asynchronous TR, and Control. In the Synchronous group, parents will receive real-time coaching via video conferencing for 12 weeks, whereas the Asynchronous group process will be managed through video analysis and delayed feedback mechanisms. The Control group will be provided with standard digital educational materials.
The primary outcome measures of the study include Goal Attainment Scaling (GAS) scores, the Parental Self-Efficacy Instrument, and the Parenting Stress Index. Secondary measures will include the Bayley Scales of Infant and Toddler Development (Bayley-IV), the Alberta Infant Motor Scale (AIMS), and the Hammersmith Infant Neurological Examination (HINE). Data will be collected at baseline (T0) and post-intervention (T1) by an assessor blinded to group allocation. The findings obtained from this study aim to demonstrate the clinical efficacy of different TR models, thereby providing guidance for the planning and dissemination of remote healthcare services for high-risk infants.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 48 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Biruni University is the lead sponsor of 180 studies on the registry; 45 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the synchronous group will receive a 12-week telerehabilitation program based on a 'parent coaching' model. The intervention consists of weekly 45-minute real-time video consultations via Zoom. To optimize session efficiency, parents receive standardized pre-session guidance (camera setup, infant readiness) via WhatsApp. The physiotherapist acts as a remote coach, providing live verbal and visual feedback to guide parents as the primary implementers during natural daily routines (play, feeding, care). Each session involves evaluating Goal Attainment Scaling (GAS) objectives from the previous week and collaborative development of new motor strategies and environmental modifications tailored to the infant's current developmental needs.
Other: Synchronous Telerehabilitation Group
Participants in the asynchronous group will follow a 12-week telerehabilitation program based on a parent coaching model with a delayed feedback principle. To ensure therapeutic intensity equivalent to the synchronous sessions, parents will record and submit 10-15 minutes of video clips weekly, showing intervention activities integrated into daily routines (play, feeding, care). These videos are shared via secure, end-to-end encrypted messaging. The physiotherapist performs a detailed analysis of the parents' handling techniques and the infant's movement quality. Feedback is provided through recorded demonstration videos (using a model doll or the therapist) to correct or reinforce motor patterns. Each weekly cycle includes evaluating Goal Attainment Scaling (GAS) objectives and updating motor strategies based on the infant's current developmental needs.
Other: Asynchronous Telerehabilitation Group
Participants in the control group will follow a standard home-based program without active physiotherapist supervision or individualized coaching. At baseline (T0), infant-specific Goal Attainment Scaling (GAS) parameters are established. Families receive comprehensive standardized educational materials, including a 'Parent Education Booklet' (PDF) and instructional videos demonstrating motor activities and positioning. Throughout the 12-week period, families implement these strategies independently. Unlike the experimental groups, no live feedback, video analysis, or weekly goal revisions are provided; GAS goals remain fixed and are evaluated only at the 12th week (T1). For ethical monitoring, brief phone calls are conducted at weeks 4 and 8 to assess study adherence and general health, strictly excluding any therapeutic guidance or intervention updates.
A 12-week remote physiotherapy program based on a 'parent coaching' model delivered via real-time video conferencing (Zoom). The intervention consists of weekly 45-minute sessions where the physiotherapist acts as a coach, providing live verbal and visual guidance to parents as the primary implementers of the intervention. Activities are integrated into the infant's natural daily routines (play, feeding, care). Pre-session standardized guidance (camera positioning, infant readiness) is provided via WhatsApp. Clinical progress is monitored through weekly evaluation and updating of Goal Attainment Scaling (GAS) objectives tailored to the infant's developmental needs.
A 12-week remote physiotherapy program based on a parent coaching model using a delayed feedback principle. To ensure therapeutic intensity equivalent to synchronous sessions, parents record and submit 10-15 minutes of video clips weekly through secure, end-to-end encrypted messaging. These clips demonstrate intervention activities integrated into daily routines (play, feeding, care). The physiotherapist performs a detailed analysis of handling techniques and movement quality, providing feedback via recorded demonstration videos (using a model doll or the therapist) to correct or reinforce motor patterns. Each weekly cycle includes evaluating Goal Attainment Scaling (GAS) objectives and updating motor strategies based on the infant's current developmental needs.
Goal Attainment Scaling
Goal Attainment Scaling (GAS) is a standardized method used to evaluate the achievement of individualized treatment goals in pediatric rehabilitation. For each infant, 3 to 5 SMART (specific, measurable, attainable, relevant, and time-bound) goals are collaboratively established by the physiotherapist and the family. Each goal is scored on a 5-point scale: -2 (baseline level), -1 (less than expected), 0 (expected outcome), +1 (more than expected), and +2 (much more than expected). The raw scores are converted into a standardized T-score using the formula with a mean of 50 and a standard deviation of 10. A T-score of 50 or higher indicates that the intervention has successfully met or exceeded the expected goals.
Time frame: Baseline and after 12 weeks
Parental Self-Efficacy Instrument for Children with Disabilities
The Parental Self-Efficacy Scale, developed by Guimond et al. (2005) and adapted into Turkish by Cavkaytar et al. (2014), assesses the self-efficacy perceptions of parents of children with disabilities regarding their caregiving and child-rearing capacities. The scale consists of 17 items rated on a 5-point Likert-type scale. It is primarily administered as a self-report tool, with researchers providing assistance (reading items) for illiterate participants if necessary. The Turkish version demonstrated high internal consistency (Cronbach's Alpha = 0.95) and test-retest reliability (r = 0.79). Total scores range from 17 to 85, where higher scores indicate a greater sense of parenting competence and self-efficacy in their roles.
Time frame: Baseline and after 12 weeks
Parenting Stress Index - Short Form (PSI-SF)
The Parenting Stress Index - Short Form (PSI-SF), originally developed by Abidin (1983) and validated in Turkish by Mert et al. (2008), is a 36-item self-report instrument designed to assess stress within the parent-child system. It consists of three subscales (12 items each): Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. The Total Stress score is calculated by summing these three subscale scores. Total scores range from 36 to 180, where higher scores represent higher levels of perceived parenting stress. The Turkish version demonstrated internal consistency (Cronbach's Alpha = 0.71 for Total Stress; 0.76-0.81 for subscales) and high test-retest reliability (r = 0.88).
Time frame: Baseline and after 12 weeks
Hammersmith Infant Neurological Examination
The Hammersmith Infant Neurological Examination (HINE) is a standardized, quantitative tool for the neurological assessment of infants aged 2 to 24 months. It comprises three sections: (1) a 26-item neurological examination assessing cranial nerve function, posture, movement quality, muscle tone, and reflexes; (2) an 8-item assessment of developmental motor milestones; and (3) a 3-item behavioral assessment. The total neurological score is derived from the 26 items in the first section, with a maximum possible score of 78. Higher scores indicate better neurological development and maturity.
Time frame: Baseline and after 12 weeks
Bayley Scales of Infant and Toddler Development, Fourth Edition
The Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-IV) is a comprehensive assessment used to evaluate developmental functioning in infants and toddlers aged 16 days to 42 months. It covers five primary domains: Cognitive, Language (Receptive and Expressive), Motor (Fine and Gross), Social-Emotional, and Adaptive Behavior. The assessment involves interactive tasks with the child and caregiver questionnaires. Standardized composite scores are calculated for each domain, with scores below the 10th percentile indicating a risk of developmental delay. For this study, all assessments will be conducted by certified researchers to ensure standardized administration and scoring.
Time frame: Baseline and after 12 weeks
Alberta Infant Motor Scale
The Alberta Infant Motor Scale (AIMS), developed by Piper and Darrah (1992), is a norm-referenced standardized instrument used to assess the gross motor development of infants from birth through independent walking (approx. 18 months). It consists of 58 items distributed across four postural positions: prone (21), supine (9), sitting (12), and standing (16). Scoring is based on clinical observation of weight-bearing, postural alignment, and anti-gravity movements. The total score ranges from 0 to 58, where higher scores indicate more advanced gross motor maturation (Piper \& Darrah, 1992; Eliks et al., 2022).
Time frame: Baseline and after 12 weeks
Telehealth Usability Questionnaire
The Telehealth Usability Questionnaire (TUQ), developed by Parmanto et al. (2016) and validated in Turkish (Ozden et al., 2021), is a 21-item instrument designed to evaluate the quality of telerehabilitation services, software, and systems. It assesses six domains: usefulness, ease of use and learnability, interface quality, interaction quality, reliability, and satisfaction. Items are rated on a 7-point Likert scale (1=Strongly Disagree, 7=Strongly Agree). Total scores range from 21 to 147, where higher scores indicate greater usability and satisfaction with the telehealth system. This scale will be used to compare the technical infrastructure performance and family-system interaction levels for both synchronous and asynchronous models.
Time frame: Baseline and after 12 weeks
Telemedicine Satisfaction Questionnaire
The Telehealth Satisfaction Questionnaire (TSQ), developed by Yip et al. (2003) and validated in Turkish (Ozden et al., 2021), is a 14-item instrument designed to assess the level of satisfaction among participants receiving telehealth services. The questionnaire uses a 5-point Likert-type scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Total scores range from 14 to 70, where higher scores indicate a higher level of satisfaction with the telerehabilitation service provided.
Time frame: Baseline and after 12 weeks
Plan to share: No — Individual participant data will not be shared to protect the privacy of the infants and their families, as the study involves sensitive developmental data and video recordings. Ethical approval from the Institutional Review Board does not include permission for public data sharing.
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for May 2027, 12 months later.
Of 741 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 12 months is below that.
Counting every sponsor, half of 759 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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