Virtual Reality in Children With Cerebral Palsy

NCT ID: NCT02500433

Last Updated: 2015-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-01-31

Brief 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. 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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device: Kinect-Xbox360TM

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.

Group Type: EXPERIMENTAL

Device: Kinect-Xbox 360TM

Intervention Type: OTHER

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 therapy

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.

Group Type: OTHER

Conventional therapy

Intervention Type: OTHER

Interventions

Device: Kinect-Xbox 360TM

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.

Intervention Type: OTHER

Conventional therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: lead

Responsible Party

Laura Luna

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Luna, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Rey Juna Carlos

Other Identifiers

VR CHILDREN 2015

Identifier Type: -

Identifier Source: org_study_id