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Wii-habilitation of arm and hand Function in Children with Cerebral Palsy, an explorative study.


- candidate number7677
- NTR NumberNTR2176
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jan-2010
- Secondary IDs30777 CCMO
- Public TitleWii-habilitation of arm and hand Function in Children with Cerebral Palsy, an explorative study.
- Scientific TitleWii-habilitation of Upper Extremity Function in Children with Cerebral Palsy, an explorative study.
- ACRONYMWiiCP
- hypothesisThe primary objective of this explorative study is to evaluate the training effect on the upper extremity function in children with Cerebral Palsy using the Wii computer, which is a Virtual Reality intervention.

The secondary objective is to evaluate the user satisfaction and usability of WiiTM computer training for the user and the health professional.
- Healt Condition(s) or Problem(s) studiedCerebral palsy, Upper extremity, Children
- Inclusion criteria1. Ages between 6 and 12 years;
2. Have impairment of the upper extremity primarily or secondary to cerebral palsy;
3. Have the ability to hold on to the game controller;
4. Are able to stretch actively and bend shoulder and elbow of the affected arm;
5. Improvement of upper extremity function is a current goal for rehabilitation;
6. Have normal or corrected to normal vision and hearing.

Discriptive caracteristics:
1. Gender;
2. Age;
3. Rehabilitation diagnosis;
4. Affected side;
5. Dominant side;
6. CP classification according to the Gross Motor Function Classification System (GMFCS) (6);
7. CP classification according to the Manual Ability Classification Scale (MACS)(7);
8. Zancolli classification for the fingers and wrist (16);
9. House classification for thumb deformities (17);
10. Current treatments for upper extremity function;
11. Current treatments;
12. Previous experience with VR, WiiTM computer games and computer games in general.
- Exclusion criteria1. Epilepsy not under control with medication;
2. Impairment of the upper extremity due to other causes then primarily or secondary to cerebral palsy;
3. Unable to understand instructions for using the intervention.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 26-feb-2010
- planned closingdate26-feb-2011
- Target number of participants10
- Interventions30 minute with Wii exercise games 2 times a week for 6 weeks.
- Primary outcome1. The Assisting Hand Assessment;
2. Melbourne Assessment;
3. ABILHAND- Kids.
- Secondary outcome1. User Satisfaction Questionnaire;
2. Health professional usability questionnaire.
- Timepoints1. Basiline = primary outcome measurements;
2. Two weeks no training;
3. T1= primary outcome measurements;
4. 6 weeks intervention;
5. T2 = primary outcome measurements + secundary outcome measurements.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. L.A. Torcque
- CONTACT for SCIENTIFIC QUERIESPhD T.M. Raaij, van
- Sponsor/Initiator Roessingh Research and Development
- Funding
(Source(s) of Monetary or Material Support)
Roessingh Research & Development
- PublicationsN/A
- Brief summaryRationale:
Impaired upper extremity function is the main problem for half of the children diagnosed with Cerebral Palsy with unilateral hemiparese and contributes significantly to difficulties in performing activities of daily living. Typical therapy uses purposeful activity and task-specific training to improve motor function and independence. There are several potential advantages of Virtual reality (VR) en exercise gaming for rehabilitation. VR facilitates real time performance feedback, safety, independent training, a capacity to increase the complexity of tasks, and it can record advantages. The most import and strength to therapy is the ability of VR to provide a motivational and fun therapy.

Objectives:
The primary objective of this explorative study is to evaluate the training effect on the upper extremity function in children with Cerebral Palsy using the Wii computer, which is a Virtual Reality intervention. The secondary objective is to evaluate the user satisfaction and usability of WiiTM computer training for the user and the health professional.

Design:
In this explorative study, a multiple baseline design is used to examine individual changes in arm function after training with a WiiTM computer. This study consists of two pre- and one post training primairy outcome measurements of functional aspects of upper extremity movements. The Children will attend 12 , half an hour, sessions in total. 2 times a week for 6 Weeks. After the intervention the secondary outcome measurements will be obtained.

Study population:
Ten children with spastic cerebral palsy will participate in the study. They will be recruited from the regional rehabilitation centre “Het Roessingh” (Enschede, The Netherlands), where children with physical disabilities are treated during school-time.

Endpoints:
Primary endpoints: The Assisting Hand Assessment; Melbourne Assessment; ABILHAND- Kids.
Secondary endpoints: User Satisfaction Questionnaire; Health professional usability questionnaire.
- Main changes (audit trail)
- RECORD23-jan-2010 - 31-jan-2010


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