Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-09 @ 3:43 PM
Study NCT ID:
NCT02500433
Status:
COMPLETED
Last Update Posted:
2015-07-16
First Post:
2015-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality in Children With Cerebral Palsy
Sponsor:
Universidad Rey Juan Carlos
Organization:
Study Overview
Official Title:
Use of a Low Cost Videogame Console in Children With Cerebral Palsy in a School Environment
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: