Overview

This trial is active, not recruiting.

Condition movement disorders
Treatment individually customized physiotherapy
Sponsor University Hospital of North Norway
Collaborator University of Tromso
Start date March 2010
End date October 2016
Trial size 150 participants
Trial identifier NCT01089296, 1/370-00/09-A

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Other)
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.
individually customized physiotherapy 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.
(No Intervention)
Ordinary follow up in the Neonatal Intensive Care Unit (NICU).

Primary Outcomes

Measure
Peabody Developmental Motor Scales(PDMS-2)
time frame: Two years post term age

Secondary Outcomes

Measure
Test of Infant Motor Performance Screening Items (TIMPSI), General Movement Assessment (GMA),Test of Infant Motor Performance(TIMP), Alberta Infant Motor Scale (AIMS), Peabody Developmental Motor Scales (PDMS-2)
time frame: TIMPSI: 34 w (baseline). GMA: 34 w, 36 w, 3 mo. TIMP: 37 w, 3 mo. AIMS: 3 mo, 6 mo, 12 mo. PDMS-2: 6 mo, 12 mo, 24 mo.

Eligibility Criteria

Male or female participants up to 10 weeks old.

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. 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. - All children who fill the inclusion criteria will be included to begin with. - If at a later stage they are unable to manage the tests due to their condition they will be excluded.

Additional Information

Official title Parental Participation in Individually Customized Physiotherapy for Preterm Infants in the Neonatal Intensive Care Unit: Effects and Experiences. The Pragmatic Randomized Controlled Part.
Principal investigator Gunn K. Øberg, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University Hospital of North Norway.