Condition category
Nervous System Diseases
Date applied
28/11/2012
Date assigned
29/11/2012
Last edited
10/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Janet Eyre

ORCID ID

Contact details

Sir James Spence Institute4th Floor
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
+44 191 282 1386
j.a.eyre@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11138

Study information

Scientific title

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

Acronym

Study hypothesis

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

21/04/2011, ref: 11-NE-0027

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/04/2012

Overall trial end date

30/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 70; UK Sample Size: 70

Participant 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

Recruitment start date

01/04/2012

Recruitment end date

30/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sir James Spence Institute
4th Floor
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.newcastle-hospitals.org.uk

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

10/05/2016: No publications found, verifying study status with principal investigator.