Early therapy in perinatal stroke study
| ISRCTN | ISRCTN12547427 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12547427 |
| Secondary identifying numbers | 19197 |
- Submission date
- 30/09/2015
- Registration date
- 30/09/2015
- Last edited
- 22/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
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 December 2018
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
Contact information
Scientific
Sir James Spence Institute
4th Floor, Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
 ORCID ID |
0000-0002-1356-3027 |
|---|
Study information
| Study design | Non-randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Early intervention to improve motor outcome after perinatal stroke: eTIPS pilot feasibility study |
| Study acronym | eTIPS |
| 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(s) | West of Scotland Research Ethics Service, 03/07/2015, ref: 15/WS/0129 |
| Condition | Topic: Children, Reproductive health and childbirth; Subtopic: All Diagnoses, Reproductive Health and Childb (all Subtopics); Disease: Reproductive Health & Childbirth, All Diseases |
| Intervention | 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 | Other |
| Primary outcome measure | Current Primary Outcome Measure (as of 10/01/2018) Feasibility and acceptability of approach determined monthly throughout the intervention period, including at a qualitative interview of therapists working with the infants, with parental consent, towards the end of the infant's involvement in the eTIPS intervention. Previous Primary Outcome Measure 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. Parental 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 study start date | 03/07/2015 |
| Overall study end date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 48; UK Sample Size: 48 |
| 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 exclusion criteria | Current Participant Exclusion Criteria (as of 10/01/2018) 1. 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) 2. Evidence of significant bilateral intracerebral pathology 3. Strokes shown radiologically to affect only occipital, prefrontal or temporal areas of the brain (which would not be expected to produce adverse motor outcomes) 4. Ongoing involvement in another research study where this is likely to interfere with the interpretation of either study Previous 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 | 03/08/2015 |
| Recruitment end date | 02/10/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
NE7 7DN
United Kingdom
TS19 9PE
United Kingdom
TS4 3BW
United Kingdom
SR4 7TP
United Kingdom
Harton Lane
South Shields
Tyne and Wear
NE34 0PL
United Kingdom
Hollyhurst Road
Darlington
County Durham
DL3 6HX
United Kingdom
North Shields
Tyne and Wear
NE29 8NH
United Kingdom
Newtown Rd
Carlisle
CA2 7HY
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Victoria Infirmary
New Victoria Wing
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom
"ROR" |
https://ror.org/05p40t847 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 01/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The trialists 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. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available to preserve confidentiality given the relatively small sample size. The data is held at Newcastle University by Dr Basu. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/07/2018 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
22/09/2021: Acronym added.
18/12/2018: IPD sharing statement added.
12/12/2018: Publication reference added.
10/01/2018: The following changes were made:
1. Overall trial start date was changed from 01/07/2015 to 03/07/2015.
2. Recruitment start date was changed from 14/07/2015 to 03/08/2015.
3. Recruitment end date was changed from 14/07/2017 to 02/10/2017.
4. Overall trial end date was changed from 31/07/2017 to 31/12/2018.
5. Intention to publish date was changed from 01/01/2018 to 01/06/2018.
6. Four trial participating centres were added.
7. Participant exclusion criteria and primary outcome measure were updated.
