NCT01089296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

March 18, 2010

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
Last Updated

January 6, 2023

Status Verified

March 1, 2021

Enrollment Period

6.7 years

First QC Date

March 16, 2010

Last Update Submit

January 5, 2023

Conditions

Movement Disorders

Keywords

Infants born pretermEarly physiotherapy interventionMotor developmentParental participationParental competency

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (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)

    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.

Study Arms (2)

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.

Other: Individually customized physiotherapy

Control

NO INTERVENTION

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

Interventions

Individually customized physiotherapyOTHER

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.

Also known as: Physiotherapy, Physical Therapy, Premature birth, Early Intervention
Individually customized physiotherapy

Eligibility Criteria

Age7 Days - 10 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Troms, 9013, Norway

Location

Related Publications (5)

  • 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.

    PMID: 38348930DERIVED

  • 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.

    PMID: 37993837DERIVED

  • 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.

    PMID: 31944250DERIVED

  • 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.

    PMID: 27440658DERIVED

  • 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.

    PMID: 22336194DERIVED

MeSH Terms

Conditions

Movement Disorders

Interventions

Physical Therapy ModalitiesEarly Intervention, Educational

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationChild Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Gunn K. Øberg, PhD

    University of Tromsø / University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2010

First Posted

March 18, 2010

Study Start

March 18, 2010

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

January 6, 2023

Record last verified: 2021-03

Locations

NO(1)