Physiotherapy of At-Risk Infants, Physiotherapist or Family?

Problem With Growth of an Infant Clinical Trial

— Infant  

Official title:

Physiotherapy of At-Risk Infants, Physiotherapist or Family? A Randomized Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681289
• Other study ID #: GO13 186-01
• Status: Completed
• Phase: N/A
• First received: February 7, 2016
• Last updated: February 11, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Early physiotherapy reduces neuromotor problems in at-risk infants. This study was planned to compare the effects of an early goal-directed neuromotor physiotherapy (GDNT) application between preterm and term at-risk infants.

Description:

Early physiotherapy reduces neuromotor problems in at-risk infants. This study was planned to compare the effects of an early goal-directed neuromotor physiotherapy (GDNT) application between preterm and term at-risk infants. Eighteen at-risk infants between the ages of 0 and 12 months were assigned to the preterm and term groups according to their gestational and corrected age. Each group received GDNT for 45 min, three days per week for 12 weeks. The effectiveness of the therapy was measured using Alberta Infant Motor Scale (AIMS), Hammersmith Infant Neurological Examination (HINE), and Goal Attainment Scale (GAS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Months

Eligibility

Inclusion Criteria:

• being diagnosed as "at-risk" by a pediatric neurologist, having intraventricular hemorrhage, periventricular leucomalacia, hypoxic ischemic encephalopathy, and prematurity, Apgar score of 5 or less at 5 min, chronic lung disease, seizures, meningitis, hyperbilirubinemia, being twins or triplets, and having intrauterine growth restriction;

• being outside of the neonatal intensive care unit;

• being between 0 and 12 months old (corrected age for premature infants);

• having a family acceptance for the participation in 12 weeks of therapy program.

Exclusion Criteria:

• having congenital anomalies, musculoskeletal disorders, cyanotic congenital heart disease and mechanical dependency, and

• lack of informed content by the parents.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Problem With Growth of an Infant

Intervention

Other:
• Early goal directed neuromotor therapy
Early goal directed neuromotor therapy (NGDT) is referred to as 'task-oriented' and is built on contemporary system theories of motor control. The development and learning of new skills occur in an interaction between the child, the task to be performed and the particular environment in which the activity takes place.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hacettepe University	Tubitak

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hammersmith Infant Neurological Examination (HINE)	It includes three sections, the Neurological Examination, the Development of Motor Functions and the State of Behaviour.The data obtained in the second and third sections are not included in the calculation of global optimality scores. The overall score ranges from a minimum of 0 to a maximum of 78. At 9 or 12 months, the scores equal or above 73 are regarded as optimal, if below 73 as sub-optimal; while at 3 and 6 months healthy term infants scored equal or above 67 and 70 (median) respectively.	12 weeks	Yes
Primary	Alberta Infant Motor Scale (AIMS)	This scale is a norm-referenced observational tool designed for the evaluation of gross motor development in infants from birth to 18 months of age or the acquisition of independent walking. It consists of 58 items and four subscales: supine (9 items), prone (21 items), sitting (12 items) and standing (16 items), which are observed in postural alignment, antigravity movements and surface contact.The obtained score (0-60 points) was converted to a normative age-dependent percentile rank (5th,10th,25th, 50th, 75th or 90th percentiles). A score less than the 10th percentile was classified as possibly delayed motor development.	12 weeks	Yes
Primary	Goal Attainment Scale (GAS)	GAS methods required practitioners to set rehabilitation goals in collaboration with the client and family. or significant others, such as a carer. For each goal, the client and practitioner developed detailed and very specific observable and quantifiable descriptions of possible outcomes Five outcome levels were identified,including the expected or desired level of performance or outcome, 2 levels that would be seen as less favourable and 2 levels that were more favourable. The 5 recommended outcome levels for each goal were assigned numeric values from -2 (the least favourable outcome) to +2 (the most favourable outcome). The expected outcome or goal was assigned 0.	12 weeks	Yes