Effectiveness of Telerehabilitation in High Risk of Infants

Early Intervention Clinical Trial

Official title:

Effectiveness of Telerehabilitation-Based Family-Centered Goal-Directed Physiotherapy Approach in High Risk of Infants and Role of Family Factors in Physiotherapy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05333224
• Other study ID #: 09.2021.853
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 2022

Study information

• Verified date: December 2021
• Source: Saglik Bilimleri Universitesi
• Contact: Ayca Evkaya Acar, MSc
• Phone: 02162803333
• Email: aycaevkaya[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

While the mortality rate in preterm births has decreased thanks to recent developments in the field of medicine, disability risk factors increase for premature babies. Premature birth, low birth weight, and all accompanying problems in this process reveal the concept of the risky baby. Early intervention is very important for these babies who are at risk for neurodevelopmental problems. Although early intervention is a general concept, the subject the investigators focus on is early physiotherapy approaches. Early physiotherapy approaches include many methods. However, recently, family-centered approaches have been emphasized and studies have been carried out on this issue; Likewise, the goal-oriented therapy approach, which is a treatment with a high level of evidence, is also being investigated. Telerehabilitation, on the other hand, has become a method that is frequently used with the increase in the use of technological methods. The effectiveness of family-centered, goal-oriented physiotherapy approaches is known in previous studies on this subject; There are studies conducted on a remotely monitored portable intelligent system created for telerehabilitation, but no studies have been found in which telerehabilitation has been applied using the real-time video conferencing method. It has also been reported in the literature that the development of risky infants is affected by factors such as the education level of families, their economic status, mental health, perceived support level, and the mother-infant relationship.

Description:

Babies in whom negative biological and environmental factors cause neuromotor developmental problems are defined as "risk babies". Risky babies are classified differently. This classification; may be according to gestational age, birth weight, and pathophysiological problems. Especially, premature babies born at 32 weeks and under 1500 g, babies with periventricular leukomalacia, hypoxic-ischemic encephalopathy, intraventricular hemorrhage, and intrauterine growth retardation are in the high-risk group. The mortality rate in risky babies has decreased considerably in recent years, but with this decrease, neurodevelopmental disorders including motor problems, incoordination, cognitive impairment, attention problems, or developmental problems are seen in these babies who live prematurely, and the risk of Cerebral Palsy (CP) occurs. CP is the common name of a group of non-progressive permanent disorders that primarily lead to impairment in movement and posture development and activity limitation, and that can also be seen in addition to sensory and cognitive problems, due to permanent damage to the developing brain. The primary condition for early intervention is to identify babies who may have CP. Early detection may be beneficial for the initiation of early intervention in the period when neuroplasticity is high. Based on neuroplasticity knowledge, it is thought that it will be beneficial for risky babies during development, and it may be possible to prevent neurodevelopmental problems and permanent disabilities, with early intervention and protective approaches. In general, the early intervention approach includes supporting the development of babies who are at risk for developmental delay or disability by providing the necessary support, treatment, and training, starting from the neonatal period and up to 24 months. Early intervention methods have many components and require a multidisciplinary approach. Methods can focus on different approaches according to the determined goals. Physiotherapy and rehabilitation approaches are of great importance in supporting the development and improving functional outcomes in early intervention. It is aimed to provide normal sensory input and gain normal functional movements by using the rapid learning ability originating from brain plasticity, and to reach the most independent level that the child can reach in terms of physical, cognitive, and psychosocial aspects within the anatomical and physiological deficiencies and environmental limitations. There are many early physiotherapy and rehabilitation approaches that focus on motor development and normalization. Goal-oriented therapy; is known as an approach that facilitates the participation and adaptation of infants and children with motor developmental delay to daily life activities. Goal-oriented neuromotor therapy approach; It is a set of movements organized around a functional goal and the environment enables the movement to occur. Studies on rehabilitation have recently focused on treatment approaches that focus on functionality in accordance with the "Activity and Participation" area of ICF. It is known that babies also have levels of functionality that enable them to participate in activities of daily living. In a study in which goal-oriented neuromotor therapy was applied in early rehabilitation applications, it was stated that this approach could be applied by both the physiotherapist and the family under the control of the physiotherapist. Family-centered physiotherapy applications have come to the fore in recent years, it is the treatment approach that focuses on the environment and what the child can do and practiced by family. Motor reactions are activated by providing normal sensory input. Telerehabilitation is the delivery of rehabilitation services by computer-based technologies and communication tools by rehabilitation specialists. It is an emerging method that provides rehabilitation services by reducing time, distance, and cost barriers and using technological tools. 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 a consensus has not yet been reached on which therapy approach is more successful. No study has been found in which family education of risky infants was followed up with telerehabilitation before. Family cooperation is very important for the implementation of early developmental screening. Family perception of the importance of follow-up may be one of the factors affecting attendance at follow-up appointments in clinical settings. A stressful neonatal intensive care environment; can affect understanding of complex information currently available, including optimizing developmental outcomes and the benefit of long-term neurodevelopmental follow-up. The time to inform the family about the risk of disability may differ from person to person. Some parents may not always welcome information about the risk of disability at admission to the acute neonatal intensive care unit. Others may value the early presentation of this information as it allows them to adjust emotionally, plan for early intervention, and make adjustments to meet their child's needs, and prefer early detection of developmental deficiencies/disability for ease of access to early intervention. While this is potentially beneficial for early intervention, there is some concern that widespread cerebral palsy screening programs have the potential to cause unnecessary parental anxiety. Therefore, it is critical to include responsive parent and clinician involvement in early screening programs for developmental delay. The high attrition rates in caregivers can partly be explained by family characteristics. Draper et al. In a study conducted by M.D., younger (less than 24 years old), highly fertile, and foreign mothers were less likely to respond to parental follow-up questionnaires. Other factors reported in the literature include lower socioeconomic status, lower social support, and lower maternal education levels. There is evidence that both low socioeconomic status and specific biological variables are risk factors for poor developmental outcomes in the preterm population. Current studies examining the effects of socioeconomic level emphasize the important effect of educational status on neurodevelopmental outcomes. It has been reported that as the education of the caregiver's increases for babies born younger than 29 weeks of gestation, cognitive and language scores increase and the scores approach the average value of 100 only for babies born to mothers with the highest education level. The same results were seen for behavioral development. Situations such as maternal education level, income, occupation, and single-parent household as independent or composite variables show similar relationships with cognitive and behavioral outcomes. Positive mental health is shaped by various socioeconomic and physical environments and is an integral component of enriched relationships, especially for the mother-infant dyad. Maternal depression, anxiety, and stress; it has been associated with low maternal self-efficacy, which is defined as the mother's belief in her parenting ability. When discharged from the neonatal intensive care unit, it has been reported that the self-confidence of mothers with a history of mental health disorder decreased compared to mothers who did not. More importantly, maternal depression and anxiety in the first year of life; infant regulation disorder has been associated with behavioral difficulties and sleep disorders, as well as risky parent-infant interactions and inadequate parent care practices. It has been suggested that parents of at-risk infants experience increased levels of stress over time. However, mediators of maternal stress, depression, and anxiety include low birth weight, low maternal education, infant and child behavior difficulties, lack of family social support, and poor child health, all of which are more common in the preterm population. Consequently, research targeting psycho-socio-economic risks provides opportunities to improve the condition of vulnerable premature infants. Evidence; shows that early interventions, especially those that focus on strengthening parent-infant relationships, have a positive effect on motor, cognitive, and behavioral outcomes and can reduce parents' symptoms of depression and anxiety. The importance of supporting parent mental health is now widely recognized, and guidelines encourage starting it in the neonatal intensive care unit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 12 Months

Eligibility

Inclusion Criteria:

• Babies born before <37 weeks of gestation and treated in the neonatal intensive care unit
• Infants with neurologic abnormalities (muscle hypertonia, hypotonia, hyperarousal, and abnormal general movements or cranial ultrasound abnormalities) at moderate to high risk of cerebral palsy
• Babies referred to physiotherapy due to motor developmental delay and neurological dysfunction
• Babies whose age range is between 0-12 months (corrected age will be calculated for premature babies)
• Being diagnosed as a neurologically and developmentally risky baby
• Babies who have completed their medical treatment and are not in neonatal intensive care
• Babies of families who agreed to participate in the study and approved the informed consent form.

Exclusion Criteria:

• Babies with congenital cyanotic heart problems or cystic fibrosis
• Babies with genetic disease or congenital anomaly
• Infants on ventilator
• Babies of families who do not accept to work
• Babies of families who cannot come to the control
• Families that cannot be contacted every week
• Babies going to a special education and rehabilitation center

Related Conditions & MeSH terms

• Early Intervention

Intervention

Other:
• Telerehabilitation
Family-centered, goal-oriented early physiotherapy approaches will be applied.
• Control
Family-centered, goal-oriented early physiotherapy approaches will be applied.

Locations

Country	Name	City	State
Turkey	Marmara University Pendik Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Asztalos EV, Church PT, Riley P, Fajardo C, Shah PS; Canadian Neonatal Network and Canadian Neonatal Follow-up Network Investigators. Association between Primary Caregiver Education and Cognitive and Language Development of Preterm Neonates. Am J Perinatol. 2017 Mar;34(4):364-371. doi: 10.1055/s-0036-1592080. Epub 2016 Aug 29. — View Citation

Beaino G, Khoshnood B, Kaminski M, Marret S, Pierrat V, Vieux R, Thiriez G, Matis J, Picaud JC, Rozé JC, Alberge C, Larroque B, Bréart G, Ancel PY; EPIPAGE Study Group. Predictors of the risk of cognitive deficiency in very preterm infants: the EPIPAGE prospective cohort. Acta Paediatr. 2011 Mar;100(3):370-8. doi: 10.1111/j.1651-2227.2010.02064.x. Epub 2011 Jan 17. — View Citation

Cameron EC, Maehle V, Reid J. The effects of an early physical therapy intervention for very preterm, very low birth weight infants: a randomized controlled clinical trial. Pediatr Phys Ther. 2005 Summer;17(2):107-19. — View Citation

Draper ES, Zeitlin J, Manktelow BN, Piedvache A, Cuttini M, Edstedt Bonamy AK, Maier R, Koopman-Esseboom C, Gadzinowski J, Boerch K, van Reempts P, Varendi H, Johnson SJ; EPICE group. EPICE cohort: two-year neurodevelopmental outcomes after very preterm birth. Arch Dis Child Fetal Neonatal Ed. 2020 Jul;105(4):350-356. doi: 10.1136/archdischild-2019-317418. Epub 2019 Nov 5. — View Citation

Guellec I, Lapillonne A, Renolleau S, Charlaluk ML, Roze JC, Marret S, Vieux R, Monique K, Ancel PY; EPIPAGE Study Group. Neurologic outcomes at school age in very preterm infants born with severe or mild growth restriction. Pediatrics. 2011 Apr;127(4):e883-91. doi: 10.1542/peds.2010-2442. Epub 2011 Mar 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Telerehabilitation Satisfication Survey	To evaluate satisfication	Day 90
Primary	Bayley III	Cognitive, motor and language development of infants will be evaluated. These scores are largely used for screening, helping to identify the need for further observation and intervention, as infants who score very low are at risk for future developmental problems.	Day 0
Primary	Change on Bayley III at 1 month	Cognitive, motor and language development of infants will be evaluated. These scores are largely used for screening, helping to identify the need for further observation and intervention, as infants who score very low are at risk for future developmental problems.	Day 30
Primary	Change on Bayley III at 2 months	Cognitive, motor and language development of infants will be evaluated. These scores are largely used for screening, helping to identify the need for further observation and intervention, as infants who score very low are at risk for future developmental problems.	Day 60
Primary	Change on Bayley III at 3 months	Cognitive, motor and language development of infants will be evaluated. These scores are largely used for screening, helping to identify the need for further observation and intervention, as infants who score very low are at risk for future developmental problems.	Day 90
Primary	Hammersmith Infant Neurological Examination (HINE)	Neurological development of infants will be evaluated. The scores of the HINE can also be used to enable detection of high risk of cerebral palsy (CP) at an early age and prediction of independent sitting and walking in children with CP.	Day 0
Primary	Change on HINE at 1 month	Neurological development of infants will be evaluated. The scores of the HINE can also be used to enable detection of high risk of cerebral palsy (CP) at an early age and prediction of independent sitting and walking in children with CP.	Day 30
Primary	Change on HINE at 2 months	Neurological development of infants will be evaluated. The scores of the HINE can also be used to enable detection of high risk of cerebral palsy (CP) at an early age and prediction of independent sitting and walking in children with CP.	Day 60
Primary	Change on HINE at 3 months	Neurological development of infants will be evaluated.The scores of the HINE can also be used to enable detection of high risk of cerebral palsy (CP) at an early age and prediction of independent sitting and walking in children with CP.	Day 90
Primary	Goal Attainment Scale (GAS)	Goal-oriented approach will be evaluated. This goal-oriented measurement tool creates specific operational indicators of progress and can focus on case planning and treatment.	Day 0
Primary	Change on GAS at 1 month	Goal-oriented approach will be evaluated. This goal-oriented measurement tool creates specific operational indicators of progress and can focus on case planning and treatment.	Day 30
Primary	Change on GAS at 2 months	Goal-oriented approach will be evaluated. This goal-oriented measurement tool creates specific operational indicators of progress and can focus on case planning and treatment.	Day 60
Primary	Change on GAS at 3 months	Goal-oriented approach will be evaluated. This goal-oriented measurement tool creates specific operational indicators of progress and can focus on case planning and treatment.	Day 90
Secondary	Mindful Attention Awareness Scale	To evaluate family perception level. The range of total scores is 15 to 90, with higher scores suggesting higher levels of mindfulness.	Day 0
Secondary	Change on Mindful Attention Awareness Scale at 3 months	To evaluate family perception level. The range of total scores is 15 to 90, with higher scores suggesting higher levels of mindfulness.	Day 90
Secondary	Depression, Anxiety and Stress Scale (DASS 21)	To evaluate mental health level. Cut-off scores =60 (for DASS-total) and =21 (for the depression subscale) are labeled as "high" or "severe".	Day 0
Secondary	Change on DASS 21 at 3 months	To evaluate mental health level.Cut-off scores =60 (for DASS-total) and =21 (for the depression subscale) are labeled as "high" or "severe".	Day 90
Secondary	Parent Self-Efficacy Scale	To evaluate self-efficacy levels related to mental health. It is used to measure the self-efficacy perceptions of parents of children with disabilities regarding parenting skills.[29] The scale is a 7-point Likert type scale and consists of 17 items in total. The lowest score that can be obtained from the scale is 17 points, while the highest score is 119 points.	Day 0
Secondary	Change on Parent Self-Efficacy Scale at 3 months	To evaluate self-efficacy levels related to mental health.It is used to measure the self-efficacy perceptions of parents of children with disabilities regarding parenting skills.[29] The scale is a 7-point Likert type scale and consists of 17 items in total. The lowest score that can be obtained from the scale is 17 points, while the highest score is 119 points.	Day 90
Secondary	Spouse Support Scale	To evaluate perceived support. The lowest score that can be obtained from the scale is 27 while the highest is 81. Except for the three reverse-scored items, higher scores mean more perceived spousal support.	Day 0
Secondary	Change on Spouse Support Scale at 3 months	To evaluate perceived support. The lowest score that can be obtained from the scale is 27 while the highest is 81. Except for the three reverse-scored items, higher scores mean more perceived spousal support.	Day 90
Secondary	Multidimensional Scale of Perceived Social Support	To evaluate perceived support. The original version of the MSPSS is a 12-item scale with 7 possible responses to each statement (scored 0-6) giving a score out of a maximum of 72 with higher score indicating greater perceived social support.	Day 0
Secondary	Change on Multidimensional Scale of Perceived Social Support at 3months	To evaluate perceived support. The original version of the MSPSS is a 12-item scale with 7 possible responses to each statement (scored 0-6) giving a score out of a maximum of 72 with higher score indicating greater perceived social support.	Day 90
Secondary	Mother-to-Infant Bonding Scale	To evaluate parent-infant attachment. The MIB consists of 8 statements describing an emotional response, such as ''loving'' or ''disappointed'', which are rated on a 4-point Likert scale from very much (score¼0) to not at all (score¼3). Five items describe negative emotional responses and are reverse scored. Low scores denote good bonding. Scores can range from 0 to 24.	Day 0
Secondary	Change on Mother-to-Infant Bonding Scale at 3 months	To evaluate parent-infant attachment. The MIB consists of 8 statements describing an emotional response, such as ''loving'' or ''disappointed'', which are rated on a 4-point Likert scale from very much (score¼0) to not at all (score¼3). Five items describe negative emotional responses and are reverse scored. Low scores denote good bonding. Scores can range from 0 to 24.	Day 90
Secondary	Dyadic Coping Inventory	To evaluate attitude to stress. A total score lower than 111 means low dyadic coping, a score greater than 145 signifies higher dyadic coping than usual.	Day 0
Secondary	Change on Dyadic Coping Inventory at 3 months	To evaluate attitude to stress. A total score lower than 111 means low dyadic coping, a score greater than 145 signifies higher dyadic coping than usual.	Day 90