Effectiveness of Telerehabilitation-Based Family-Centered Goal-Directed Physiotherapy Approach in High Risk of Infants
Phase: NA
Conditions: Early Intervention
Sponsor: Saglik Bilimleri Universitesi

Study Document Cover Page 
Official Title: Effectiveness of Telerehabilitation-Based Family-Centered Goal-Directed 
Physiotherapy Approach in High-Risk Infants 
 
 
NCT Number: NCT05333224 
 
 
Document Date: 2 July 2021 
 
 
Ethics Committee Approval: 
Marmara University Clinical Research Ethics Committee 
Approval No: 09.2021.853 
Approval Date: 02.07.2021 
 
 
This document represents the complete, pre-specified study protocol and statistical analysis 
plan (SAP) approved by the human subjects protection review board and utilized for the 
conduct of the study. 
 
 

Study Protocol and StaƟsƟcal Analysis Plan (SAP) 
Title: 
EﬀecƟveness of TelerehabilitaƟon-Based Family-Centered Goal-Directed Physiotherapy 
Approach in High-Risk Infants 
NCT Number: NCT05333224 
 
1. Background 
High-risk infants, characterized by exposure to adverse biological and environmental factors, 
are prone to neuromotor developmental problems. CondiƟons such as premature birth (<32 
weeks, <1500 grams), periventricular leukomalacia, hypoxic ischemic encephalopathy, 
intraventricular hemorrhage, and intrauterine growth retardaƟon increase the risk of 
neurodevelopmental disorders, including cerebral palsy (CP). 
Early intervenƟon is criƟcal during the high neuroplasƟcity period of infancy. The primary 
condiƟon for early intervenƟon is to idenƟfy babies who may have CP. Early detecƟon can be 
beneﬁcial in terms of starƟng early intervenƟon during the period when neuroplasƟcity is high. 
It is thought that with the prominence of early intervenƟon and protecƟve approaches based 
on neuroplasƟcity knowledge, it will be beneﬁcial for babies at risk during development and it 
will be possible to prevent neurodevelopmental problems and permanent disabiliƟes. The 
early intervenƟon approach generally includes supporƟng the development of babies at risk 
for developmental delay or disability by providing the necessary support, treatment and 
training starƟng from the neonatal period and up to 24 months. Early intervenƟon methods 
have many components and require a mulƟdisciplinary approach. Methods can focus on 
diﬀerent approaches according to the determined goals. Physiotherapy and rehabilitaƟon 
approaches are of great importance in supporƟng development and improving funcƟonal 
outcomes in early intervenƟon. It is aimed to provide normal sensory input and gain normal 
funcƟonal movements by using the rapid learning ability originaƟng from brain plasƟcity, and 
to reach the most independent level that the child can reach in terms of physical, cogniƟve 
and psychosocial aspects within the anatomical and physiological deﬁciencies and 
environmental limitaƟons. There are many early physiotherapy and rehabilitaƟon approaches 
that focus on motor development and normalizaƟon. Goal-focused therapy is known as an 
approach that facilitates the parƟcipaƟon and adaptaƟon of infants and children with motor 
developmental delays in daily life acƟviƟes. Goal-focused neuromotor treatment approach is 
a set of movements organized around a funcƟonal target and provides the formaƟon of 
environmental movement. Studies on rehabilitaƟon have recently focused on treatment 
approaches that focus on funcƟonality in accordance with the “AcƟvity and ParƟcipaƟon” area 
of ICF. It is known that babies also have levels of funcƟonality that enable them to parƟcipate 
in daily life acƟviƟes. In a study where goal-focused neuromotor treatment was applied in early 
rehabilitaƟon pracƟces, it was stated that this approach can be applied by both the 

physiotherapist and the family under the control of the physiotherapist. Family-centered 
physiotherapy pracƟces have come to the fore in recent years, and are a treatment approach 
applied by the family that focuses on the environment and what the child can do. Motor 
reacƟons are acƟvated by providing normal sensory input. TelerehabilitaƟon is the provision 
of rehabilitaƟon services by rehabilitaƟon specialists with computer-based technologies and 
communicaƟon tools. It is a developing method that provides rehabilitaƟon services by 
reducing Ɵme, distance and cost barriers and using technological tools. There are previously 
studies on a portable smart system that is monitored remotely and created for early 
assessment and intervenƟon. 
Although the importance of early physiotherapy approaches is known today, when the 
literature is examined, it is seen that the number of studies is insuﬃcient and there is no 
consensus yet on which therapy approach is more successful. No previous study has been 
found in which family educaƟon of risky babies was followed up with telerehabilitaƟon. 
 
2. ObjecƟves 
Primary ObjecƟve 
Evaluate the eﬀecƟveness of family-centered, goal-directed early physiotherapy approaches 
in high-risk infants using telerehabilitaƟon. 
Secondary ObjecƟves 
1. Compare the motor, cogniƟve, and language developmental progress of infants in 
telerehabilitaƟon and single-session educaƟon groups. 
2. Assess family saƟsfacƟon with telerehabilitaƟon-based physiotherapy. 
3. Measure neurological outcomes using Hammersmith Infant Neurological ExaminaƟon 
(HINE). 
4. Determine the achievement of individualized treatment goals using the Goal 
Atainment Scale (GAS). 
 
3. Study Design 
Type of Study 
A prospecƟve, randomized, controlled trial conducted at the Risky Infants Polyclinic. 
DuraƟon 
12 weeks, with evaluaƟons conducted at baseline, 4th, 8th, and 12th weeks. 
Groups 

1. TelerehabilitaƟon-Based Group: Families received exercise training in the clinic, 
followed by weekly real-Ɵme video-conference sessions (1 day/week) and follow-up 
phone calls (2 days/week). 
2. Single-Session EducaƟon Group: Families received a single session of exercise 
training in the clinic and were asked to conƟnue the exercises independently. 
 
4. ParƟcipants 
Inclusion Criteria 
• 
Premature infants (<37 weeks) treated in neonatal intensive care units. 
• 
Infants with neurological abnormaliƟes (muscle hypertonia, hypotonia, 
oversƟmulaƟon, abnormal general movements, or cranial ultrasound abnormaliƟes). 
• 
Infants aged 0-12 months (corrected age for prematurity applied). 
• 
Diagnosed as at-risk for motor or developmental delay. 
• 
Infants whose medical treatments are complete and are no longer in neonatal 
intensive care. 
• 
Families who agree to parƟcipate and provide informed consent. 
Exclusion Criteria 
• 
Infants with congenital cyanoƟc heart disease, cysƟc ﬁbrosis, geneƟc diseases, or 
congenital anomalies. 
• 
Infants on venƟlators. 
• 
Families unable to atend regular check-ups or weekly communicaƟon. 
• 
Infants already enrolled in special educaƟon or rehabilitaƟon centers. 
 
5. Outcome Measures 
Primary Outcomes 
1. Changes in neuromotor development using the Hammersmith Infant Neurological 
Examination (HINE). 
2. Cognitive, motor, and language development using Bayley III. 
3. Goal achievement using the Goal Attainment Scale (GAS). 
Secondary Outcome 

4. Family satisfaction using a custom Satisfaction Survey. 
 
6. IntervenƟon 
Training Protocol 
• 
Exercises tailored to neuromotor developmental stages, delivered by experienced 
pediatric physiotherapists. 
• 
Families instructed to perform exercises for 30-45 minutes, 3 days per week, for 12 
weeks. 
• 
TelerehabilitaƟon group received one supervised video-conference session weekly, 
with phone call follow-ups for the remaining two days. 
• 
Single-session group received instrucƟons during one in-clinic session with no 
addiƟonal follow-up. 
 
7. Data CollecƟon and Tools 
Demographics 
• 
Collected using forms capturing infant and family data (age, educaƟon, marital status, 
economic status, number of children, etc.). 
Developmental Assessments 
1. Bayley III: Evaluates cogniƟve, motor, and language development. 
2. HINE: Assesses cranial nerve funcƟon, posture, tone, reﬂexes, and orientaƟon. 
3. GAS: Tracks individualized treatment goal achievement. 
SaƟsfacƟon Survey 
Assesses family saƟsfacƟon with treatment. 
 
8. StaƟsƟcal Analysis Plan (SAP) 
Sample Size CalculaƟon 
• 
Based on a similar study (Pineda et al., 2020), the eﬀect size was calculated as 1.09. 
• 
Using G*Power 3.1.9.2, a total sample size of 24 infants (12 per group) was 
determined for α=0.05 and power=0.95. 
StaƟsƟcal Methods 

• 
DescripƟve StaƟsƟcs: Mean, standard deviaƟon, minimum, and maximum values for 
quanƟtaƟve data; frequency and percentage for qualitaƟve data. 
• 
Group Comparisons: 
o Mann-Whitney U and chi-square tests for conƟnuous and categorical 
demographic data. 
o Wilcoxon Signed-Ranks Test for pre- and post-treatment comparisons of 
Bayley III, HINE, and GAS scores. 
• 
Signiﬁcance Level: p<0.05. 
 
9. Ethical ConsideraƟons 
• 
The study received ethical approval from the relevant insƟtuƟonal review board. 
• 
Signed informed consent obtained from all parƟcipaƟng families. 
• 
Data conﬁdenƟality and anonymity maintained throughout the study.