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| Name | Class |
|---|---|
| University of Tromso | OTHER |
| St. Olavs Hospital | OTHER |
| University of Illinois at Chicago | OTHER |
| Oslo University Hospital |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individually customized physiotherapy | 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. |
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| Control | No Intervention | Ordinary follow up in the Neonatal Intensive Care Unit (NICU). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individually customized physiotherapy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peabody Developmental Motor Scales(PDMS-2) | 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. | Two years post term age |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Results from the different Time Frames will be published successively as the project proceeds. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunn K. Øberg, PhD | University of Tromsø / University Hospital of North Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of North Norway | Tromsø | Troms | 9013 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38348930 | Derived | Orton J, Doyle LW, Tripathi T, Boyd R, Anderson PJ, Spittle A. Early developmental intervention programmes provided post hospital discharge to prevent motor and cognitive impairment in preterm infants. Cochrane Database Syst Rev. 2024 Feb 13;2(2):CD005495. doi: 10.1002/14651858.CD005495.pub5. | |
| 37993837 | Derived |
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| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
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| OTHER |
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| Ustad T, Brandal M, Campbell SK, Girolami GL, Sinding-Larsen C, Oberg GK. Concurrent and predictive validity of the Alberta Infant Motor Scale and the Peabody Developmental Motor Scales-2 administered to infants born preterm in Norway. BMC Pediatr. 2023 Nov 23;23(1):591. doi: 10.1186/s12887-023-04402-6. |
| 31944250 | Derived | Oberg GK, Girolami GL, Campbell SK, Ustad T, Heuch I, Jacobsen BK, Kaaresen PI, Aulie VS, Jorgensen L. Effects of a Parent-Administered Exercise Program in the Neonatal Intensive Care Unit: Dose Does Matter-A Randomized Controlled Trial. Phys Ther. 2020 May 18;100(5):860-869. doi: 10.1093/ptj/pzaa014. |
| 27440658 | Derived | Ustad T, Evensen KA, Campbell SK, Girolami GL, Helbostad J, Jorgensen L, Kaaresen PI, Oberg GK. Early Parent-Administered Physical Therapy for Preterm Infants: A Randomized Controlled Trial. Pediatrics. 2016 Aug;138(2):e20160271. doi: 10.1542/peds.2016-0271. |
| 22336194 | Derived | Oberg GK, Campbell SK, Girolami GL, Ustad T, Jorgensen L, Kaaresen PI. Study protocol: an early intervention program to improve motor outcome in preterm infants: a randomized controlled trial and a qualitative study of physiotherapy performance and parental experiences. BMC Pediatr. 2012 Feb 15;12:15. doi: 10.1186/1471-2431-12-15. |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |