Limbs Alive: Use of video games to provide motivating, child centred therapy to improve bimanual skills for children with hemiplegic cerebral palsy

ISRCTN	ISRCTN91944190
DOI	https://doi.org/10.1186/ISRCTN91944190
Secondary identifying numbers	11138

Submission date: 28/11/2012
Registration date: 29/11/2012
Last edited: 25/11/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Janet Eyre
Scientific

Sir James Spence Institute4th Floor
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Phone	+44 191 282 1386
Email	j.a.eyre@ncl.ac.uk

Study information

Study design	Randomised interventional trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Limbs Alive: Use of video games to provide motivating, child centred therapy to improve bimanual skills for children with hemiplegic cerebral palsy
Study objectives	The aim of this study is to find out whether bespoke video games can improve bimanual function in children with hemiplegic cerebral palsy.
Ethics approval(s)	21/04/2011, ref: 11-NE-0027
Health condition(s) or problem(s) studied	Hemiplegic cerebral palsy
Intervention	70 children with hemiplegia will be randomly allocated to intervention or placebo groups, stratified for sex and severity. The children and families will be told only that computer games are being evaluated for therapy. The research team will be blinded to group allocation. Both groups will be given the same computer games. Intervention group: successful playing will require increasing bimanual dexterity. Placebo group: increasing skill will be required of only the non-affected hand. The date, time, duration of play and score will be recorded automatically. The Intervention Group The initial grade of difficulty of the task for the paretic hand will be set to make use of their maximum skill. Bimanual dexterity will be required and the task difficulties will be interactively adjusted as part of the game to take account of increasing skill in bimanual hand use. Clinical assessments of upper limb function will be carried out at baseline, 1, 3 and 6 months by an experienced therapist.
Intervention type	Other
Primary outcome measure	Melbourne Unilateral Upper Limb Assessment at 1 month, 3 months and 6 months
Secondary outcome measures	1. Assisting Hand Assessment at 1 month, 3months and 6 months 2. Beery-Buktenica Developmental Test of Visual-Motor Integration at 1 month, 3 months and 6 months 3. Canadian Occupational Performance Measure at 1 month, 3months and 6 months 4. Kidscreen at 1 month and 6 months
Overall study start date	01/04/2012
Completion date	30/12/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	7 Years
Upper age limit	15 Years
Sex	Both
Target number of participants	Planned Sample Size: 70; UK Sample Size: 70
Key inclusion criteria	1. Hemiplegic cerebral palsy 2. Able to actively grasp the game controller with the paretic hand, though grasp need not be maintained. 3. Male & Female, age 7-15 years
Key exclusion criteria	1. IQ less than 70 2. Severe behavioural problems 3. Severe visual impairment 4. Severe fixed contractures of the wrist or elbow 5. Epilepsy induced by the flicker frequency of a computer screen
Date of first enrolment	01/04/2012
Date of final enrolment	30/12/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Sir James Spence Institute

4th Floor
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Northern Centre for Cancer Care
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England
United Kingdom

Website	http://www.newcastle-hospitals.org.uk
"ROR"	https://ror.org/05p40t847

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

25/11/2019: No publications found. Verifying results with principal investigator.
10/05/2016: No publications found, verifying study status with principal investigator.