The Norwegian Physical Therapy Study in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-18

Study Completion Date

2016-11-30

Brief Summary

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This is a pragmatic randomized controlled study. The purpose of the study is to evaluate the practice and effect of customised physiotherapy on preterm infants'motor development when the intervention is performed over a period of three weeks while the infant resides in the neonatal intensive care unit. The study will also attempt to analyze the parents' experiences in being actively involved in education and practice of the intervention designed to promote the child's motor development, and the effects on the parent-child relationship in the short and long term.The children are followed up until a corrected age of two years. This study consists of a pragmatic randomized controlled trial and a qualitative study.

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Detailed Description

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Infants born preterm with an gestational age below 32 weeks have an increased risk of developing different grades and types of abnormalities, among them delayed motor development, co-ordination difficulties and cerebral palsy. The prevalence of serious developmental abnormalities increases the lower the gestational age and birth weight. The reported incidence of mild developmental abnormalities is 15-20 % in children with a gestational age \<28 weeks or with a birth weight under 1000 g, 10-20 % in children with a gestational age of 28-31 weeks or a birth weight between 1000-1500 g and only 5 % in children born at term. The incidence of cerebral palsy is 10-20% amongst children in the first group, 5-10% in the second group and only 0,1 % in children born at term.With such a high risk of developing motor abnormalities for infants born preterm together with limited evidence-based knowledge of early physiotherapy approaches that facilitate motor development, it is essential that more research is done in this area to ensure that physiotherapy if used, is in the right manner to prevent and reduce such difficulties.

Conditions

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Movement Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Individually customized physiotherapy

The intervention involves handling the infant and changing its position. It focuses on improving symmetry, muscle balance and movement in infants. The parent who is with the infant during the admission period will carry out the daily intervention after being taught by the physiotherapist.

Group Type OTHER

Individually customized physiotherapy

Intervention Type OTHER

Main elements in the intervention are postural support and facilitating techniques. The intervention will be carried out twice a day over a three-week period if the infant's condition allows it. The length of each treatment session will be adjusted dependent on the infant's response and condition. Maximum treatment time is 10 minutes.

Control

Ordinary follow up in the Neonatal Intensive Care Unit (NICU).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Individually customized physiotherapy

Main elements in the intervention are postural support and facilitating techniques. The intervention will be carried out twice a day over a three-week period if the infant's condition allows it. The length of each treatment session will be adjusted dependent on the infant's response and condition. Maximum treatment time is 10 minutes.

Intervention Type OTHER

Other Intervention Names

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Physiotherapy Physical Therapy Premature birth Early Intervention

Eligibility Criteria

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Inclusion Criteria

* Child born before or at 32nd gestational week.
* Child that tolerates being handled at 34th week postmenstrual age.
* Parents that can perform the intervention understand and speak Norwegian.
* Follow up of the child in the hospital where the intervention is given.

* If at a later stage they are unable to manage the tests due to their condition they will be excluded.

Exclusion Criteria

* Child born later than 32nd week.
* Child who cannot tolerate being handled for up to 10 minutes at 34th postmenstrual age.
* Triplets or more.
* Child who has undergone surgery.
* Child with large deformities.
* Parents that can perform the intervention but do not understand and speak Norwegian.
* Follow up of the child is not taking place in the hospital where the intervention is given.

Minimum Eligible Age

7 Days

Maximum Eligible Age

10 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No