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Rehabilitation Specific Gaming in CP

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Rehabilitation-specific gaming platform
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Bilateral Spastic CP
  • 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:

  • received multilevel surgery in the previous year
  • IQ <70
  • visual acuity <3/10

Sites / Locations

  • UZ Leuven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

No Intervention

Arm Label

Control period

Intervention period

Wash-out period

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Goal Attainment Scale (GAS)
Evaluates the achievement of the individual goals per child and allows comparison of a heterogeneous group of children. GAS is essentially conducted on a 5-point measure, with the degree of attainment captured for each goal area. If the patient achieves the expected level, this is scored at 0. If they achieve a better than expected outcome this is scored at: +1 (Somewhat better), +2 (much better). If they achieve a worse than expected outcome this is scored at: -1 (Somewhat worse) or -2 (much worse). Goals may be weighted to take account of the relative importance of the goal to the individual, and/or the anticipated difficulty of achieving it. Overall Goal Attainment Scores are then calculated by applying a formula. The composite GAS (the sum of the attainment levels x the relative weights for each goal) is transformed into a standardised measure or T score with a mean of 50 and standard deviation of 10.

Secondary Outcome Measures

Trunk Control Measurement Scale (TCMS)
The static subsection of the TCMS evaluates static trunk control during movements of upper and lower limbs. The dynamic section the TCMS evaluates the ability to perform active trunk movements in different planes within and beyond the base of support. The total scale contains 15 items, with the subscale consisting of 5, 7 and 3 items, respectively. All items are scored on a two-, three- or four-point ordinal scale and administered bilaterally in case of clinical relevance. The total score of the TCMS ranges from 0 to 58, with a higher score indicating a better performance.
Pediatric Balance Scale (PBS)
The PBS is a modification of the Berg Balance Scale, developed as a measure for children. It measures balance functions for school-aged children and provides clinicians with a standardized format for measuring performance of functional balance tasks ranging from timed sitting balance to standing on one leg. There is a total of 14 items, each item is scored utilizing the 0 to 4 scale. The child's performance should be scored based upon the lowest criteria, which describes the child's best performance. If on the first trail a child receives the maximal socre of 4, additional trails need not to be administered.
Gross Motor Function Measure-88 (GMFM)
The GMFM is a standardized observation measure to evaluate gross motor function changes in children with CP. It is divided into five difference dimensions, ranging from lying and rolling to jumping and running. There is a total of 88 items, each item is scored using a 4-point Likert scale. Values of 0 to 3 are assigned to the four categories: 0= does not initiate, 1=initiates, 2=partially completes and 3=completes. Each of the dimensions of the GMFM has a different number of items. Each dimension contributes equally to the total score, therefore a percent score can be calculated for each dimension. A total score is obtained by calculating the mean of five dimension scores.

Full Information

First Posted
January 10, 2018
Last Updated
August 7, 2019
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Vrije Universiteit Brussel, Fondation Motrice
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1. Study Identification

Unique Protocol Identification Number
NCT03403010
Brief Title
Rehabilitation Specific Gaming in CP
Official Title
A Randomized Cross-over Design Evaluating the Effects of Using a Rehabilitation-specific Gaming Software Platform for the Achievement of Individual Physiotherapy Goals of Children With Severe Spastic Cerebral Palsy.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 5, 2016 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Vrije Universiteit Brussel, Fondation Motrice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this project is to evaluate the effectiveness of using rehabilitation-specific gaming in physical therapy of children with cerebral palsy. 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.
Detailed Description
Forty children are recruited via the Cerebral Palsy Reference Centre (University Hospital Leuven, Pellenberg). Children are recruited when they have been diagnosed with bilateral spastic CP, Gross Motor Function Classification (GMFCS) level III-IV, aged between 6 and 15y and standardly receive physiotherapy at an intensity of minimally 2 times per week, 45 minutes per session. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control period
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention period
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Wash-out period
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Rehabilitation-specific gaming platform
Intervention Description
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.
Primary Outcome Measure Information:
Title
Goal Attainment Scale (GAS)
Description
Evaluates the achievement of the individual goals per child and allows comparison of a heterogeneous group of children. GAS is essentially conducted on a 5-point measure, with the degree of attainment captured for each goal area. If the patient achieves the expected level, this is scored at 0. If they achieve a better than expected outcome this is scored at: +1 (Somewhat better), +2 (much better). If they achieve a worse than expected outcome this is scored at: -1 (Somewhat worse) or -2 (much worse). Goals may be weighted to take account of the relative importance of the goal to the individual, and/or the anticipated difficulty of achieving it. Overall Goal Attainment Scores are then calculated by applying a formula. The composite GAS (the sum of the attainment levels x the relative weights for each goal) is transformed into a standardised measure or T score with a mean of 50 and standard deviation of 10.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Trunk Control Measurement Scale (TCMS)
Description
The static subsection of the TCMS evaluates static trunk control during movements of upper and lower limbs. The dynamic section the TCMS evaluates the ability to perform active trunk movements in different planes within and beyond the base of support. The total scale contains 15 items, with the subscale consisting of 5, 7 and 3 items, respectively. All items are scored on a two-, three- or four-point ordinal scale and administered bilaterally in case of clinical relevance. The total score of the TCMS ranges from 0 to 58, with a higher score indicating a better performance.
Time Frame
3 months
Title
Pediatric Balance Scale (PBS)
Description
The PBS is a modification of the Berg Balance Scale, developed as a measure for children. It measures balance functions for school-aged children and provides clinicians with a standardized format for measuring performance of functional balance tasks ranging from timed sitting balance to standing on one leg. There is a total of 14 items, each item is scored utilizing the 0 to 4 scale. The child's performance should be scored based upon the lowest criteria, which describes the child's best performance. If on the first trail a child receives the maximal socre of 4, additional trails need not to be administered.
Time Frame
3 months
Title
Gross Motor Function Measure-88 (GMFM)
Description
The GMFM is a standardized observation measure to evaluate gross motor function changes in children with CP. It is divided into five difference dimensions, ranging from lying and rolling to jumping and running. There is a total of 88 items, each item is scored using a 4-point Likert scale. Values of 0 to 3 are assigned to the four categories: 0= does not initiate, 1=initiates, 2=partially completes and 3=completes. Each of the dimensions of the GMFM has a different number of items. Each dimension contributes equally to the total score, therefore a percent score can be calculated for each dimension. A total score is obtained by calculating the mean of five dimension scores.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Bilateral Spastic CP 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: received multilevel surgery in the previous year IQ <70 visual acuity <3/10
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Rehabilitation Specific Gaming in CP

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