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Movement DisordersNCT01089296

The Norwegian Physical Therapy Study in Preterm Infants

A study testing Individually customized physiotherapy in people with Movement Disorders, run by University Hospital of North Norway at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 days to 10 weeks
Conditions the study is for
Movement Disorders
What is being tested?
Individually customized physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
1 siteNorway
Study dates
18 Mar 2010to 30 Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 days to 10 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • University Hospital of North Norway

    Tromsø, Troms, 9013

Other trials in Norway

About this study

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.

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.

Read the 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.

Being tested
Individually customized physiotherapy
Keywords
Infants born preterm, Early physiotherapy intervention, Motor development, Parental participation, Parental competency
Medical subject headings
Movement Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individually customized physiotherapyOther

    Also called Physiotherapy, Physical Therapy, Premature birth, Early Intervention

    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.

Study groups in NCT01089296
Study groupRoleWhat they receive
Individually customized physiotherapyOtherThe 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.
Receives: Other: Individually customized physiotherapy
ControlNo interventionOrdinary follow up in the Neonatal Intensive Care Unit (NICU).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Two years post term age

Secondary outcomes (1)

  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)

    Results from the different Time Frames will be published successively as the project proceeds.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2010 (estimated)
  2. Study start18 Mar 2010
  3. Primary completion30 Nov 2016
  4. Study completion30 Nov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01089296
Sponsor's protocol ID
1/370-00/09-A
Status last verified
Mar 2021
First submitted
16 Mar 2010
Last updated
6 Jan 2023
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38348930

  • 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.

    PubMed 37993837

  • 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.

    PubMed 31944250

  • 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.

    PubMed 27440658

  • 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.

    PubMed 22336194

Questions about this trial

What is this clinical trial studying?

A study testing Individually customized physiotherapy in people with Movement Disorders, run by University Hospital of North Norway at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peabody Developmental Motor Scales(PDMS-2) (time frame: Two years post term age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01089296, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.

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