Cerebral PalsyNCT02500433
Virtual Reality in Children With Cerebral Palsy
A study testing Device: Kinect-Xbox 360TM and Conventional therapy in people with Cerebral Palsy, run by Universidad Rey Juan Carlos.
Trial summary
OBJECTIVE: To investigate whether VR videogames plus conventional therapy improves motor control compared with conventional therapy in children with cerebral palsy (CP). METHODS: Thirty participants with CP were included. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Device: Kinect-Xbox 360TM and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnostic of mild-moderate hemiplegic.
- Diplegic cerebral palsy.
- Age between four to eleven years.
- Receive physiotherapy treatment in the public.
- School related with this project
Who cannot join
- Not Have Visual Impairments.
- Severe Cognitive Disability.
- Surgical Intervention In The Year Before Study Onset.
- Botulinum Injections In The Six Months Before Study Onset.
- Non-Controlled Epilepsy.
About this study
Official title: Use of a Low Cost Videogame Console in Children With Cerebral Palsy in a School Environment
OBJECTIVE: To investigate whether VR videogames plus conventional therapy improves motor control compared with conventional therapy in children with cerebral palsy (CP).
METHODS: Thirty participants with CP were included. A baseline (A0), a post-conventional intervention (A1), a post-experimental treatment (A2) and a two-month follow-up (A3) assessment were performed. Experimental intervention was based on videogames treatment (Kinect-Kbox360TM) added to their conventional physiotherapy. Motor and the process skills were evaluated by the Assessment of Motor and Process Skills (AMPS); balance by the Pediatric Reach test (PRT); gait speed by the 10-meters walk test (10MW); and running and jumping capacity by the Gross Motor Function Measure (GMFM).
Read the detailed description
Thirty participants were recruited, seventeen were boys and thirteen were girls, with a mean age of 8.41 years (SD 2.55).
The inclusion and exclusion criteria Children were recruited from Public Schools of Madrid (Spain) and they were classified according to their Gross Motor Function Classification System (GMFCS) level.
The inclusion criteria were a diagnostic of mild-moderate hemiplegic and diplegic CP, age between four to eleven years and receive physiotherapy treatment in the public school related with this project. The exclusion criteria were not have visual impairments, severe cognitive disability, surgical intervention in the year before study onset, botulinum injections in the six months before study onset and non-controlled epilepsy. Six participants were classified as GMFCS level I and twenty-four was level II, all with spastic involvement.
All were receiving physiotherapy at the time of enrollment by the same therapist. All children were enrolled in age-appropriate classes in regular public schools; 100% did receive some extra help for mild learning issues.
Statistical Analyses:
We used a repeated measures analysis of variance (ANOVA) to assess differences among the four assessments in each of the variables, using paired t-test with Bonferroni correction when a significant effect was detected. We performed all the analysis by The Statistical Package for Social Sciences (SPSS 19.0 Version).The statistical analysis was conducted at a 95% confidence level. A p value <0.05 was considered statistically significant.
- Conditions
- Cerebral Palsy
- Being tested
- Device: Kinect-Xbox 360TM, Conventional therapy
- Keywords
- Cerebral palsy, child, rehabilitation, video games, virtual reality.
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Kinect-Xbox 360TMOther
Based around a webcam-style add-on peripheral for the Xbox 360 console, it enables users to control and interact with the Xbox 360 without the need to touch a game controller, through a natural user interface using gestures and spoken commands. Participants were asked to practice 30 minutes per day, 2 days per week for 2 months, added to their conventional treatment. The games used were Kinect Sports ITM, Kinect Joy RideTM and Kinect Disneyland AdventuresTM and involved balance and trunk movements, general and visual-manual coordination and limb tasks. Each subject followed instructions on the screen with the help of his physiotherapist, with points awarded based on degree and speed of movement and level of difficulty.
Conventional therapyOther
| Study group | Role | What they receive |
|---|---|---|
| Device: Kinect-Xbox360TM | Experimental | Based around a webcam-style add-on peripheral for the Xbox 360 console, it enables users to control and interact with the Xbox 360 without the need to touch a game controller, through a natural user interface using gestures and spoken commands. Participants were asked to practice 30 minutes per day, 2 days per week for 2 months, added to their conventional treatment. The games used were Kinect Sports ITM, Kinect Joy RideTM and Kinect Disneyland AdventuresTM and involved balance and trunk movements, general and visual-manual coordination and limb tasks. Each subject followed instructions on the screen with the help of his physiotherapist, with points awarded based on degree and speed of movement and level of difficulty.
Participants were initially exposed to the games in an hour introductory session, 2 weeks before the study began. All the sessions were supervised by physiotherapist. Receives: Other: Device: Kinect-Xbox 360TM |
| Conventional therapy | Other | Conventional therapy was based on neurodevelopment treatment, psychomotor activities and kinesiotherapy during one month, twice per week, with 30 minutes per session.
The treatment includes: active and passive kinesitherapy, muscle and tendons stretching, training of gait and deambulation, such as coordination and handling. Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Motor and Process Skills (AMPS)
Observational assessment used to measure the quality of a person's activities of daily living (ADL). The person performs each prioritized and self-chosen ADL task in a familiar environment and the way he or she usually does it. After completion of each AMPS task observation, the occupational therapist scores the person's quality of performance on each of 16 ADL motor and 20 ADL process items according to the standardized criteria in the AMPS manual. Each task performance observed is scored separately and each ADL skill is rated using a 4-point ordinal scale. Once the evaluation is complete, the therapist enters the raw scores for each ADL task observed into the AMPS software. The AMPS software is then used to perform many-facet Rasch analyses of the person's ordinal raw items scores and generate linear quality of ADL task performance measures.
Measured: 60 minutes
10-meters walk test (10MW)
participants positioned their toes behind the start line and were instructed to walk at their comfortable speed and continue down the corridor until told to stop. Timing began the moment the participant initiated a step and ended when the leading foot crossed the finish line.
Measured: 15 minutes
Pediatric Reach test (PRT)
is a valid and reliable measure with potential for use with children. Children were instructed to lean forward with their arms, moving at their ankles only, as far as possible without lifting their heels off the ground, and to maintain that position for three seconds. The average in centimeters of the three arms reach trials was used.
Measured: 5 minutes
Gross Motor Function Measure (GMFM).
The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with CP, is the standard outcome assessment tool for functional intervention in CP. For this paper, standing and gait, running and jumping scales were used.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Luna, Universidad Rey Juan Carlos
- Investigators
- Laura Luna, PhD, Principal investigator, Universidad Rey Juna Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500433
- Sponsor's protocol ID
- VR CHILDREN 2015
- Status last verified
- Jul 2015
- First submitted
- 9 Jun 2015
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Low Cost Videogame Console in Children With Cerebral Palsy in a School Environment
- ClinicalTrials.gov ID
- NCT02500433
- Acronym / sponsor ID
- VR CHILDREN 2015
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, child, rehabilitation, video games, virtual reality.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVE: To investigate whether VR videogames plus conventional therapy improves motor control compared with conventional therapy in children with cerebral palsy (CP).
METHODS: Thirty participants with CP were included. A baseline (A0), a post-conventional intervention (A1), a post-experimental treatment (A2) and a two-month follow-up (A3) assessment were performed. Experimental intervention was based on videogames treatment (Kinect-Kbox360TM) added to their conventional physiotherapy. Motor and the process skills were evaluated by the Assessment of Motor and Process Skills (AMPS); balance by the Pediatric Reach test (PRT); gait speed by the 10-meters walk test (10MW); and running and jumping capacity by the Gross Motor Function Measure (GMFM).
Detailed description
Thirty participants were recruited, seventeen were boys and thirteen were girls, with a mean age of 8.41 years (SD 2.55).
The inclusion and exclusion criteria Children were recruited from Public Schools of Madrid (Spain) and they were classified according to their Gross Motor Function Classification System (GMFCS) level.
The inclusion criteria were a diagnostic of mild-moderate hemiplegic and diplegic CP, age between four to eleven years and receive physiotherapy treatment in the public school related with this project. The exclusion criteria were not have visual impairments, severe cognitive disability, surgical intervention in the year before study onset, botulinum injections in the six months before study onset and non-controlled epilepsy. Six participants were classified as GMFCS level I and twenty-four was level II, all with spastic involvement.
All were receiving physiotherapy at the time of enrollment by the same therapist. All children were enrolled in age-appropriate classes in regular public schools; 100% did receive some extra help for mild learning issues.
Statistical Analyses:
We used a repeated measures analysis of variance (ANOVA) to assess differences among the four assessments in each of the variables, using paired t-test with Bonferroni correction when a significant effect was detected. We performed all the analysis by The Statistical Package for Social Sciences (SPSS 19.0 Version).The statistical analysis was conducted at a 95% confidence level. A p value <0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device: Kinect-Xbox360TM | Experimental | Other: Device: Kinect-Xbox 360TMBased around a webcam-style add-on peripheral for the Xbox 360 console, it enables users to control and interact with the Xbox 360 without the need to touch a game controller, through a natural user interface using gestures and spoken commands. Participants were asked to practice 30 minutes per day, 2 days per week for 2 months, added to their conventional treatment. The games used were Kinect Sports ITM, Kinect Joy RideTM and Kinect Disneyland AdventuresTM and involved balance and trunk movements, general and visual-manual coordination and limb tasks. Each subject followed instructions on the screen with the help of his physiotherapist, with points awarded based on degree and speed of movement and level of difficulty. Participants were initially exposed to the games in an hour introductory session, 2 weeks before the study began. All the sessions were supervised by physiotherapist. |
| Conventional therapy | Other | Other: Conventional therapyConventional therapy was based on neurodevelopment treatment, psychomotor activities and kinesiotherapy during one month, twice per week, with 30 minutes per session. The treatment includes: active and passive kinesitherapy, muscle and tendons stretching, training of gait and deambulation, such as coordination and handling. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnostic of mild-moderate hemiplegic.
- Diplegic cerebral palsy.
- Age between four to eleven years.
- Receive physiotherapy treatment in the public.
- School related with this project
Key exclusion criteria (5 listed)
- Not Have Visual Impairments.
- Severe Cognitive Disability.
- Surgical Intervention In The Year Before Study Onset.
- Botulinum Injections In The Six Months Before Study Onset.
- Non-Controlled Epilepsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Kinect-Xbox 360TMBased around a webcam-style add-on peripheral for the Xbox 360 console, it enables users to control and interact with the Xbox 360 without the need to touch a game controller, through a natural user interface using gestures and spoken commands. Participants were asked to practice 30 minutes per day, 2 days per week for 2 months, added to their conventional treatment. The games used were Kinect Sports ITM, Kinect Joy RideTM and Kinect Disneyland AdventuresTM and involved balance and trunk movements, general and visual-manual coordination and limb tasks. Each subject followed instructions on the screen with the help of his physiotherapist, with points awarded based on degree and speed of movement and level of difficulty. | Other | Device: Kinect-Xbox360TM |
| Conventional therapy | Other | Conventional therapy |
Primary outcome
Assessment of Motor and Process Skills (AMPS)
Time frame: 60 minutes
Observational assessment used to measure the quality of a person's activities of daily living (ADL). The person performs each prioritized and self-chosen ADL task in a familiar environment and the way he or she usually does it. After completion of each AMPS task observation, the occupational therapist scores the person's quality of performance on each of 16 ADL motor and 20 ADL process items according to the standardized criteria in the AMPS manual. Each task performance observed is scored separately and each ADL skill is rated using a 4-point ordinal scale. Once the evaluation is complete, the therapist enters the raw scores for each ADL task observed into the AMPS software. The AMPS software is then used to perform many-facet Rasch analyses of the person's ordinal raw items scores and generate linear quality of ADL task performance measures.
10-meters walk test (10MW)
Time frame: 15 minutes
participants positioned their toes behind the start line and were instructed to walk at their comfortable speed and continue down the corridor until told to stop. Timing began the moment the participant initiated a step and ended when the leading foot crossed the finish line.
Pediatric Reach test (PRT)
Time frame: 5 minutes
is a valid and reliable measure with potential for use with children. Children were instructed to lean forward with their arms, moving at their ankles only, as far as possible without lifting their heels off the ground, and to maintain that position for three seconds. The average in centimeters of the three arms reach trials was used.
Gross Motor Function Measure (GMFM).
Time frame: 45 minutes
The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with CP, is the standard outcome assessment tool for functional intervention in CP. For this paper, standing and gait, running and jumping scales were used.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Luna, PhD principal investigator
Universidad Rey Juna Carlos
Questions about this trial
What is this clinical trial studying?
A study testing Device: Kinect-Xbox 360TM and Conventional therapy in people with Cerebral Palsy, run by Universidad Rey Juan Carlos.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Motor and Process Skills (AMPS) (time frame: 60 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2015.