Rehabilitation Specific Gaming in CP

August 7, 2019 updated by: Universitaire Ziekenhuizen KU Leuven

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 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.
Active Comparator: 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.
Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Goal Attainment Scale (GAS)
Time Frame: 3 months
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.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trunk Control Measurement Scale (TCMS)
Time Frame: 3 months
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.
3 months
Pediatric Balance Scale (PBS)
Time Frame: 3 months
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.
3 months
Gross Motor Function Measure-88 (GMFM)
Time Frame: 3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vrije Universiteit Brussel
Fondation Motrice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • s59104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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