Developing technology-based hand and arm activity tracking for children with hemiplegia

ISRCTN ISRCTN24515760
DOI https://doi.org/10.1186/ISRCTN24515760
Secondary identifying numbers CPMS: 42944
Submission date
11/11/2019
Registration date
18/11/2019
Last edited
06/03/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Hemiplegic Cerebral Palsy (HCP) causes lifelong weakness and stiffness of one side of the body. Upper limb therapy at effective intensity is not accessible to most. The aim of this study is to determine whether wrist-worn devices and software (smartphone application) incorporating positive feedback and peer support encourages use of the affected arm and hand during everyday activities.

Who can participate?
20 children/young people aged 8-18 years old who have HCP. In addition, 20 typically developing controls or “buddies” in the same age range will also be recruited. Participants of any gender can be included in this study.

What does the study involve?
Participants, both those with HCP and typically developing controls, wear two wrist-worn devices, on one each wrist. These devices contain accelerometers and measure the participants’ arm movements. They wear the devices for 10 weeks. The first two weeks involve establishing a baseline for each participant i.e. how much do they normally move their arms? In the following 6 weeks, participants with hemiplegia receive vibratory and/or auditory prompts from the device, to remind them to move their affected arm more. These prompts are based on their baseline movement and their individual personalised thresholds they have set for planned increase in movement. If they are not on target, they receive a prompt. “Buddies” do not receive any prompts. The device communicates with a mobile phone application via Bluetooth, on which participants are able to view the processed data, and play a game at the end of the day. The idea of the game is to incentivise participants to increase the movement of their affected arm, as they are rewarded for doing so by having access to an enjoyable game. Additionally, participants and their parents receive a weekly phone call/Skype call from a researcher, during which, they are asked various questions about how they are finding the project and give them a chance to express any difficulties they may have been experiencing. The phone calls are tailored to whether they are a child/young person with HCP, or a buddy. Therapists of the participants with HCP also receive a phone call, asking their opinions on the TwoCan project and about treatment for HCP in general.

What are the possible benefits and risks of participating?
Possible benefits of taking part include potential improvement of movement of the affected arm in children/young people with hemiplegia. When taking part in the study there is a risk that participants may experience fatigue and/or discomfort due to the increased level of activity of their affected arm, in an attempt to reach their threshold. If this is the case, a lower threshold will be set for this child.

Where is the study run from?
The study will be run from the participants’ homes, as they will be wearing the devices in their everyday lives. However, the clinical centres will be Newcastle upon Tyne Hospitals NHS Foundation Trust and Guy’s and St Thomas’ NHS Foundation Trust (London) (UK)

When is the study starting and how long is it expected to run for?
December 2019 to December 2021 (updated 19/08/2021, previously: August 2021 (updated 05/08/2020, previously: September 2020))

Who is funding the study?
Action Medical Research (AMR) and the EPSRC Digital Economy Research Centre

Who is the main contact?
Dr Anna Basu
anna.basu@newcastle.ac.uk

Study website

Contact information

Dr Anna Basu
Scientific

Level 3, Sir James Spence Institute
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

ORCiD logoORCID ID 0000-0002-1356-3027
Phone +44 (0)191 282 1375
Email anna.basu@newcastle.ac.uk
Mrs Janice Pearse
Scientific

Level 3, Sir James Spence Institute
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Phone +44 (0)191 2821381
Email Janice.pearse@newcastle.ac.uk

Study information

Study designObservational; Design type: Qualitative/proof of concept
Primary study designObservational
Secondary study designQualitative/proof of concept
Study setting(s)Home
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleDeveloping technology-based hand and arm activity tracking for children with hemiplegia: the TwoCan Project
Study objectivesTo establish whether a wrist-worn device and software (including a smartphone application), incorporating positive feedback and peer support, will encourage increased use of the affected arm and hand, of those with hemiplegia, during everyday activities.
Ethics approval(s)Approved 25/10/2019, West Midlands – Edgbaston Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; Tel: +44 (0)2071048071; Email: NRESCommittee.WestMidlands-Edgbaston@nhs.net), ref: 19/WM/0257
Health condition(s) or problem(s) studiedHemiplegic cerebral palsy (HCP)
InterventionFollowing baseline observational assessments of hand function, participants will wear two wrist-worn devices, on one each wrist which will measure the participants’ arm movements. They will wear the devices for 10 weeks. The first two weeks will involve establishing a baseline for each participants i.e. how much do they normally move their arms? In the following six weeks, participants will receive vibratory and/or auditory prompts from the device in an attempt to remind them to move their affected arm more. These prompts will be based on their baseline movement and their individual personalised thresholds. If they are not on target, they will receive a prompt. “Buddies” will not receive any prompts. The device communicates with a mobile phone application via Bluetooth.
Participants will receive weekly telephone/skype contact for feedback and any troubleshooting. At the end of the study they will also take part in a qualitative interview about their experiences.
Intervention typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure1. Feasibility and acceptability of the approach assessed through qualitative interviews with participants at the end of the study
2. Recruitment rate recorded as the number of eligible participants who consent to participate in the study within 6 months
3. Attrition rate recorded as the number of participants who consent to participate that remain in the study until the end of follow up at 10 weeks
Secondary outcome measuresArm movement measured by wrist-worn accelerometer continuously for approximately 12 hours/day for the whole 10-week period
Overall study start date01/12/2019
Completion date31/12/2021

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 100; UK Sample Size: 100
Key inclusion criteria1. Children/young people (male or female) with HCP who: are 8-18 years old, and have Manual Ability Classification (MACS) level I-III
2. Typically developing controls (male or female) who: are 8-18 years old, and have normal hand function
3. Therapists of children with HCP who: are either physiotherapists or occupational therapists, and provide input related to upper limb function
4. For all of the above, adequate command of the English language and fully informed consent are required
Key exclusion criteria1. Those registered blind or partially sighted
2. Those unable to detect vibratory cues to wrist from the device
3. Those with significant cognitive and/or language deficit precluding ability to use the device and application
4. Those with current involvement in another research study likely to interfere with the conduct of this study
Date of first enrolment01/01/2020
Date of final enrolment31/03/2021

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Great North Children’s Hospital
Newcastle upon Tyne Hospitals NHS Foundation Trust
Level 3, Sir James Spence Institute
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Evelina Children's Hospital
Guy’s and St Thomas’ NHS Foundation Trust
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Sponsor information

The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Hospital/treatment centre

Newcastle Joint Research Office
Level 1, Regent Point
Regent Farm Road
Gosforth
Newcastle-Upon-Tyne
NE7 7DN
England
United Kingdom

Phone +44 (0)191 282 23070
Email karen.verrill@nhs.net
ROR logo "ROR" https://ror.org/05p40t847

Funders

Funder type

Government

Action Medical Research; Grant Codes: GN2707
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
actionmedres, action medical research for children, AMR
Location
United Kingdom

Results and Publications

Intention to publish date31/08/2023
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThe study protocol will be made available on request. The researchers will submit the research findings for publication in peer-reviewed scientific journals and as conference presentations. They also intend to write an article for young people with hemiplegia and their families, to disseminate through the HemiHelp group (now part of the organisation Contact).
IPD sharing planThe datasets generated and/or analysed during this study are not expected to be made available in order to maintain patient confidentiality given the small study size and qualitative nature of much of the data.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications Participatory design workshops 21/12/2022 01/02/2023 Yes No
Results article 30/01/2023 01/02/2023 Yes No
Protocol file version 1.9 12/09/2019 06/03/2023 No No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN24515760_PROTOCOL_V1.9_12Sep19.pdf

Editorial Notes

06/03/2023: Protocol uploaded (not peer reviewed).
01/02/2023: Publication references added.
23/08/2022: The intention to publish date was changed from 31/08/2022 to 31/08/2023.
19/08/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/08/2021 to 31/12/2021.
2. The intention to publish date was changed from 01/04/2022 to 31/08/2022.
3. The plain English summary was updated to reflect these changes.
17/02/2021: The recruitment end date was changed from 28/02/2021 to 31/03/2021.
03/09/2020: The recruitment resumed.
05/08/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/07/2020 to 28/02/2021.
2. The overall end date was changed from 30/09/2020 to 31/08/2021.
3. The intention to publish date was changed from 01/10/2021 to 01/04/2022.
4. The plain English summary was updated to reflect these changes.
14/04/2020: Due to current public health guidance, recruitment for this study has been paused.
11/11/2019: Trial's existence confirmed by the NIHR.