Cerebral Palsy Clinical Trial
Official title:
Use of a Low Cost Videogame Console in Children With Cerebral Palsy in a School Environment
Verified date | July 2015 |
Source | Universidad Rey Juan Carlos |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Comité Ético de Investigación Clínica |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 30 |
Est. completion date | January 2015 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years to 11 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Universidad Rey Juan Carlos |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 60 minutes | Yes |
Primary | 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. | 15 minutes | Yes |
Primary | 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. | 5 minutes | Yes |
Primary | 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. | 45 minutes | Yes |
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