Condition category
Neonatal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cerebral palsy (CP) is a condition which affects movement, posture and coordination. It is caused by an injury to the parts of the brain responsible for controlling muscles, usually before or very soon after birth. Hemiplegic cerebral palsy (HCP) is a type of CP where only one side (hemisphere) of the brain is affected, causing weakness or stiffness on one side of the body. The main cause of HCP is a perinatal stroke (a stroke occurring around the time of birth). Although strokes are usually associated with older people, the risk of a newborn baby having a stroke is just as high in the first 28 days of life. The stroke may be caused by a blood clot or a bleed (haemorrhage), however both lead to the brain being starved of oxygen. During the first six months of life, an infant’s nervous system undergoes extensive development. This process is hindered in cases of perinatal strokes and children who go on to develop HCP are unable to use the affected side of the body. Currently there are no early therapy options for infants with perinatal stroke. The aim of this study is to find out whether a home-based therapy given by parents is a practical option for treating infants with perinatal stroke.

Who can participate?
Infants who have had a stroke before the age of three months and aged matched healthy infants.

What does the study involve?
Parents or carers of infants who have suffered from a perinatal stroke are taught how to give therapy to their children using educational materials, as well as supervision and support from a trained therapist. The movement of the children’s arms and legs is monitored in monthly visits using lightweight movement detectors. All assessments are videoed and compared to healthy infants of the same age. After five months, the parents or guardians of the infants are interviewed for their opinions of the therapy.

What are the possible benefits and risks of participating?
Participants will benefit from the study as it should be an enjoyable experience and the development of infants who have suffered a perinatal stroke may be improved. There are no notable risks of taking part in the study.

Where is the study run from?
Royal Victoria Infirmary, Newcastle Upon Tyne (UK)

When is the study starting and how long is it expected to run for?
January 2015 to July 2017

Who is funding the study?
1. National Institute for Health Research (UK)
2. Newcastle Health Care Charity (UK)

Who is the main contact?
Dr Anna Basu

Trial website

Contact information



Primary contact

Dr Anna Basu


Contact details

Sir James Spence Institute
4th Floor
Queen Victoria Road
Newcastle Upon Tyne
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Early intervention to improve motor outcome after perinatal stroke: eTIPS pilot feasibility study


Study hypothesis

The aim of this study is to assess the feasibility of using a therapy intervention, from birth or from diagnosis to six months, in babies who have suffered a perinatal stroke.

Ethics approval

West of Scotland Research Ethics Service, 03/07/2015, ref: 15/WS/0129

Study design

Non-randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Children, Reproductive health and childbirth; Subtopic: All Diagnoses, Reproductive Health and Childb (all Subtopics); Disease: Reproductive Health & Childbirth, All Diseases


Interventions for infants with stroke: A manualised home-based parent delivered therapy approach with therapist oversight. Additional information and tips for the approach including videos are provided through a website. The approach is pervasive, can be incorporated into everyday life and lasts until the infant is 6 months of age.

Interventions for typically developing infants: No formal intervention is indicated. However, parents are given a baby massage manual and access to the relevant website, and requested to follow the instructions and provide feedback on the materials.

Intervention type



Drug names

Primary outcome measures

Feasibility and acceptability of approach determined monthly throughout the intervention period, including at a qualitative interview at 5 months.

Secondary outcome measures

1. Rates of eligibility, consent, participation and retention throughout the study.
2. Infant motor development is measured using the Alberta Infant Motor Scale at baseline, 2, 4 and 6 months, Prechtl’s General Movement Assessments at baseline, 1, 2 and 3 months, the Hand Assessment for Infants at 3, 4, 5 and 6 months, and the Pediatric Stroke Outcome Measure at baseline, 3 and 6 months (the latter for infants with perinatal stroke only)
3. PParental well-being and sense of competence are measured using the Warwick-Edinburgh Mental Wellbeing scale and the Parenting Sense of Competence scale respectively at 1 month and 6 months
4. Exploratory outcomes are measured using Accelerometry at each visit (infant limb movements) and the eTIPS feasibility questionnaire (perinatal stroke group only) at 1 month and 6 months

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Infants who sustained a predominantly unilateral stroke (arterial ischaemic, haemorrhagic or haemorrhagic periventricular venous infarction) demonstrated on cranial imaging and identified within the first 3 months of life
2. Aged matched health infants (control group)
3. Fully informed parental consent and parent/carer with the ability and willingness to adhere to protocol

Participant type


Age group




Target number of participants

Planned Sample Size: 48; UK Sample Size: 48

Participant exclusion criteria

1. Extreme prematurity, of less than 26 weeks gestation
2. Additional significant medical diagnoses which would render the therapy inappropriate or outcomes uninterpretable in relation to the therapy (e.g. known progressive or neurodegenerative disorder; severe visual impairment)
3. Evidence of significant bilateral intracerebral pathology
4. Strokes shown radiologically to affect only occipital, prefrontal or temporal areas of the brain (which would not be expected to produce adverse motor outcomes)
5. Ongoing involvement in another research study where this is likely to interfere with the interpretation of either study

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne
United Kingdom

Trial participating centre

North Tees and Hartlepool NHS Foundation Trust
North Tees
TS19 9PE
United Kingdom

Trial participating centre

South Tees Hospitals NHS Foundation Trust
South Tees
United Kingdom

Trial participating centre

City Hospitals Sunderland NHS Foundation Trust
United Kingdom

Sponsor information


Newcastle upon Tyne Hospitals NHS Foundation Trust

Sponsor details

Royal Victoria Infirmary
New Victoria Wing
Queen Victoria Road
Newcastle Upon Tyne
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

Funder name

Newcastle Health Care Charity

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

We intend that paper summarising the findings of the pilot feasibility study will be published in 2018, as will a paper describing the results of the infant movement analysis and a paper discussing the qualitative research findings.

Intention to publish date


Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes