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The Norwegian Physical Therapy Study in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01089296
Recruitment Status : Active, not recruiting
First Posted : March 18, 2010
Last Update Posted : April 5, 2017
University of Tromso
St. Olavs Hospital
University of Illinois at Chicago
Oslo University Hospital
Information provided by (Responsible Party):
University Hospital of North Norway

Brief 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.

Condition or disease Intervention/treatment Phase
Movement Disorders Other: Individually customized physiotherapy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : March 2010
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Other: 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.
Other Names:
  • Physiotherapy
  • Physical Therapy
  • Premature birth
  • Early Intervention

No Intervention: Control
Ordinary follow up in the Neonatal Intensive Care Unit (NICU).

Primary Outcome Measures :
  1. Peabody Developmental Motor Scales(PDMS-2) [ Time Frame: Two years post term age ]
    PDMS-2 assess both fine- and gross motor function. Even though our Primary Outcome Measure is at two years post term age, we are going to publish results from assessments at earlier ages when they exist for the whole sample as the study proceeds.

Secondary Outcome Measures :
  1. 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. ]
    Results from the different Time Frames will be published successively as the project proceeds.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01089296

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University Hospital of North Norway
Tromsø, Troms fylke, Norway, 9013
Sponsors and Collaborators
University Hospital of North Norway
University of Tromso
St. Olavs Hospital
University of Illinois at Chicago
Oslo University Hospital
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Principal Investigator: Gunn K. Øberg, PhD University of Tromsø / University Hospital of North Norway

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital of North Norway Identifier: NCT01089296     History of Changes
Other Study ID Numbers: 1/370-00/09-A
First Posted: March 18, 2010    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Keywords provided by University Hospital of North Norway:
Infants born preterm
Early physiotherapy intervention
Motor development
Parental participation
Parental competency
Additional relevant MeSH terms:
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Movement Disorders
Central Nervous System Diseases
Nervous System Diseases