Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2016-12-05
2018-09-30
Brief Summary
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The primary goal of this project is to evaluate the effectiveness of integrating 15 to 20 minutes of gaming using a rehabilitation-specific gaming platform into standard physiotherapy sessions on the achievement of individual goals of children with bilateral spastic cerebral palsy with GMFCS level III-IV.
The secondary goal of this project is to evaluate the effectiveness of integrating 15 to 20 minutes of gaming using a rehabilitation-specific gaming platform into standard physiotherapy sessions on trunk control and gross motor function of children with bilateral spastic cerebral palsy with GMFCS level III-IV.
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Detailed Description
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Children are randomized into the intervention group (conventional, usual therapy including the use of rehabilitation-specific gaming) or the control group (PT, usual physiotherapy not including gaming), followed by a cross-over. After the intervention period of 3 months, wash-out period will be organized to evaluate follow-up effects.
During the intervention period, the usual individual physiotherapy program of the child will be continued as performed before the study and will be executed by the child's usual, familiar physiotherapist. The therapist will be asked to use the rehabilitation-specific gaming software every therapy session, for at least 15 to 20 minutes. The therapist will receive an extensive introduction and demonstration of the software and the researchers will participate in at least one therapy session.
During the control period, the usual, conventional physiotherapy of the child will be continued and the therapist will be asked not to use any gaming activities. Also during the control period, the frequency and duration of the therapy sessions will not be influenced by the researchers.
A wash-out period in between both programs, assumes that therapy effects are still present for a certain period after the intervention and therefore aims to wash-out these effects. Therefore, this period is considered after each intervention period. As during the control period, therapy will be continued as usual during the washout-period but no gaming is allowed during therapy.
All intervention and control periods will have the same duration of 3 months. During all periods, therapists will receive a diary to register the exact amount of therapy performed. The diary that will be provided during the intervention, will also question the specific games played and will register the therapy goals strived for.
Children will be evaluated before and after each intervention or control period using a multidimensional assessment protocol. In addition, children will also receive a follow-up evaluation 3 months after the last intervention period. This will result in 4 evaluation moments for each child. The evaluation exist of the Goal Attainment Scale, the Gross Motor Function Measure, the Pediatric Balance Scale, the Trunk Control Measurement Scale and the Dimensions of Mastery Motivation Questionnaire (DMQ).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Control period
In this group conventional physiotherapy of the child will be continued and the therapist will be asked not to use any gaming activities. Also during the control period, the frequency and duration of the therapy sessions will not be influenced by the researchers.
No interventions assigned to this group
Intervention period
In this group the usual individual physiotherapy program of the child will be continued as performed before the study and will be executed by the child's usual, familiar physiotherapist. The therapist will be asked to use the rehabilitation-specific gaming software every therapy session, for at least 15 to 20 minutes. The therapist will receive an extensive introduction and demonstration of the software and the researchers will participate in at least one therapy session.
Rehabilitation-specific gaming platform
The rehabilitation specific gaming software was developed as part of the ICT4rehab project with partners from the Vrije Universiteit Brussel and the University Libre de Bruxelles. The ICT4Rehab puts several ICT tools supporting 2/3D user interaction into place. The games can be controlled using a Kinect camera system (Microsoft(®) (Redmond, WA) Kinect™) or a Wii balance board (® NintendoTM, Japan), depending on the choice of the therapist and the needs of the child.
Wash-out period
The wash-out period is considered after each intervention period. As during the control period, therapy will be continued as usual during the washout-period but no gaming is allowed during therapy.
No interventions assigned to this group
Interventions
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Rehabilitation-specific gaming platform
The rehabilitation specific gaming software was developed as part of the ICT4rehab project with partners from the Vrije Universiteit Brussel and the University Libre de Bruxelles. The ICT4Rehab puts several ICT tools supporting 2/3D user interaction into place. The games can be controlled using a Kinect camera system (Microsoft(®) (Redmond, WA) Kinect™) or a Wii balance board (® NintendoTM, Japan), depending on the choice of the therapist and the needs of the child.
Eligibility Criteria
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Inclusion Criteria
* Gross Motor Function Classification (GMFCS) level III-IV,
* Aged between 6 and 15y
* Standardly receive physiotherapy at an intensity of minimally 2 times per week, 45 minutes per session.
Exclusion Criteria
* IQ \<70
* visual acuity \<3/10
6 Years
15 Years
ALL
No
Sponsors
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Vrije Universiteit Brussel
OTHER
Fondation Motrice
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Locations
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UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Countries
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Other Identifiers
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s59104
Identifier Type: -
Identifier Source: org_study_id
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