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 |
| Protocol serial number | 11138 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) |
- 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
Scientific
Sir James Spence Institute4th Floor
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
| Phone | +44 191 282 1386 |
|---|---|
| j.a.eyre@ncl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Melbourne Unilateral Upper Limb Assessment at 1 month, 3 months and 6 months |
| Key secondary outcome measure(s) |
1. Assisting Hand Assessment at 1 month, 3months and 6 months |
| Completion date | 30/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 15 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Sir James Spence Institute
4th Floor
Newcastle upon Tyne
NE1 4LP
United Kingdom
Newcastle upon Tyne
NE1 4LP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
