Effectiveness of Family Collaborative Physiotherapy Programs With High-risk Infants

NCT04035291 | Completed

• 1 other identifier: Sanko U
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems. It is a heterogeneous group of premature infants born under thirty-seven weeks of age, with infants with low birth weight, term or developmental retardation for various reasons. Therefore, preterm infants with low birth weight can survive with a neurological sequelae such as cerebral palsy (CP), epilepsy, hearing and vision loss, mental retardation, speech and speech problems, and learning difficulties. The clinical diagnosis of CP, which can be observed in high-risk infants, is based on the combination of some neurological and clinical signs. High-risk of infant follow-up programs provide guidance for the treatment of neurodevelopmental delays and deterioration in terms of early development. Three methods with the best predictable validity that can determine CP before the adjusted age of 5-month is Magnetic Resonance Imaging (MRI), Prechtl's Assessment of General Movements (GMs), Hammersmith Infant Neurological Evaluation. In recent years, the diagnosis of high-risk of CP can be detected at 3 months with predictive validity and reliability by evaluating the quality of GMs. GMs are now considered the gold standard for early detection of CP because of its high sensitivity and specificity than MRI, cranial US and neurological evaluations. It was also found that cognitive or language skills may be inadequate in school age in patients with inadequate movement character and in the same postural patterns according to age, although GMs are normal. So new clinical care guidelines and new intervention research for infants with CP under the age of 2, needed to have been shown. High-risk infants who are thought to have developmental disorders need early intervention, but it is not yet known which interventions are more effective. In the literature, although interventions are generally shown to have a greater impact on cognitive development, their contribution to motor development cannot be fully demonstrated. The effectiveness of physiotherapy programs in the diagnosis and treatment of CP has not been clarified in the past years as a silent period. Therefore, studies involving early physiotherapy programs are needed in infants at high risk for CP.

Conditions

Cerebral Palsy; Infant, Newborn, Disease; Infant, Small for Gestational Age; Infant Asphyxia; Infant, Very Low Birth Weight; Infant of Diabetic Mother; Infant, Premature, Diseases; Infant Development

Keywords

Family Collaboration,; high risk of CP; physiotherapy

Outcome Measures

Primary Outcomes (2)

• Change of Bayley Scales of Infant and Toddler Development (Bayley-III) score

  measures cognitive, language, motor, socio-emotional and adaptive behaviors of children between 0-42 months.High scores shows better development.

  3th and 6th months (before and after intervention)

• Change of Hammersmith infant neurological examination test score

  The use of the HINE optimality score and cut-off scores provides prognostic information on the severity of motor outcome. The HINE can further help to identify those infants needing specific rehabilitation programs.High scores shows better developmental stage.

  2, 3 and 6th months

Secondary Outcomes (1)

• Change of the General Movement Assessment (GMs)

  Maximum 2 times in the preterm period, 2 times until the 10th week, postterm 10th week-24. 4-6 camera recordings will be taken for 5 minutes, 2 times per week.

Study Arms (3)

Interventional

ACTIVE COMPARATOR

The first group (n = 25) will be asked to apply the physiotherapy program by the family at home that includes the principles of therapeutic handling-holding-positioning of NDT principles, starting at the third month for 8 weeks. And It will last for at least 45 minutes, 3 days a week. Family education will be evaluated after 4 weeks and improvements will be made in accordance with the motor development of the infant. The program will be implemented by families for 8 weeks.

Other: exercise

Experimental

EXPERIMENTAL

In the second study group (n = 25), family collaborative physiotherapy program will be applied by the family. This program will start from the postterm third month, and will include family trainings based on the goal-oriented active motor learning model of the baby in an 8-week in enriched environment and to include holding-carrying-positioning trainings in daily routines. Also it will last for at least 45 minutes, 7 days a week. All members of the family will be included in the family trainings and home visits will be made at 2-week intervals. Families will be encouraged to apply the physiotherapy processes of their babies in their natural environment at every moment of their daily routines (feeding, carrying on lap, gas extraction, changing the bed, sleeping, waking time, shopping moment, playing games etc.).

Other: exercise

control

NO INTERVENTION

In the third study group, families who are out of town or who cannot participate in the treatment program for other reasons will be included in the evaluations.

Interventions

exercise OTHER

exercises,play therapy models and positioning, handling and holding principles for babies, daily routins

Experimental; Interventional

Eligibility Criteria

• Age: 24 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Periventricular hemorrhage, patients with intracranial hemorrhage grade 2, 3, 4, cystic periventricular leukomalacia, Stage 3 hypoxic ischemic encephalopathy, Neonatal bilirubin encephalopathy (kernicterius), perinatal stroke, perinatal asphyxia, babies with hydrocephalus
• Chronic pulmonary disease Infants with dysplasia and long-term O₂ support
• Preterm infants with sepsis, necrotizing enterocolitis (NEC), infantile apnea, cerebral malformation due to gram negative bacteria
• Patients with a low Apgar score of 5 minutes (3 and less), multiple births (twins, triplets) diagnosed with intrauterine growth retardation, preterm infants with premature retinopathy (ROP)
• Infants with prolonged severe hypoglycemia and hypocalcemia
• Surgical conditions such as diaphragmatic hernia or tracheoesophageal fistula
• Infants younger than gestational age (Small for Gestational Age, SGA, smaller than 3rd percentile) or older than gestational age (Large for Gestational Age, LGA, greater than 97th percentile)
• Babies receiving mechanical ventilation for more than 24 hours
• Babies less than 32 weeks of gestation and born under 1500 g

You may not qualify if:

• Infants with congenital malformation (Spina Bifida, Congenital Muscular Torticollis, Arthrogriposis Multiplex Congenita etc.)
• Infants diagnosed with metabolic and genetic diseases (Down Syndrome, Spinal Muscular Atrophy, Duchenne Muscular Dystrophy etc.)
• Infants still intubated and mechanical ventilator dependent at postterm 3 months

Sponsors & Collaborators

• Sanko University: lead

Study Sites (1)

Sanko University

Gaziantep, Şehitkamil, 27090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Disease; Infant, Premature, Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hatice Adıgüzel, PhD cd.

  Sanko University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All of the interventions will be shown to the infants' (participants') parents by the investigator physiotherapist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Infants will be divided into two groups according to prenatal risk factors (maternal age, intrauterine growth retardation, chronic diseases etc.) by random minimization method and taken into 2 different physiotherapy programs. As the control group, the group participating in the evaluations stating that they cannot participate in the treatment without any intervention will be taken.

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 29, 2019
• Study Start: August 1, 2019
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

TU (1)