The Norwegian Physical Therapy Study in Preterm Infants
|ClinicalTrials.gov Identifier: NCT01089296|
Recruitment Status : Active, not recruiting
First Posted : March 18, 2010
Last Update Posted : April 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Movement Disorders||Other: Individually customized physiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
No Intervention: Control
Ordinary follow up in the Neonatal Intensive Care Unit (NICU).
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089296
|University Hospital of North Norway|
|Tromsø, Troms fylke, Norway, 9013|
|Principal Investigator:||Gunn K. Øberg, PhD||University of Tromsø / University Hospital of North Norway|