NCT05557305

Changes in Motor and Cognitive Function on Unilateral Spastic Cerebral Palsy, Associated With Videogame Therapy

Evaluation of the Usability, Safety, and Possible Beneficial Effects on Motor and Cognitive Functions Associated With Using a Neuro-rehabilitation Platform With Video Games in Pediatric Patients With Unilateral Spastic Cerebral Palsy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Universidad Nacional Autonoma de Mexico · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The use of interactive applications associated with position and movement sensors has begun to spread as an option for the reinforcement of physical rehabilitation therapies in patients with congenital or acquired motor disorders as a result of some neurological damage, due to its portability and the relative autonomy granted to the patient. However, the results of its effectiveness and impact continue to be scarce compared to the traditional therapy used for rehabilitation. The aim of this study is to explore possible benefits associated with occupational therapy with video games in patients with unilateral spastic cerebral palsy, comparing them with conventional therapy. A randomized pilot study will be carried out, with a control group. The intervention will consist of the application of a virtual rehabilitation program for the experimental group while the control group will receive only conventional therapy. Before and after the said intervention, standardized tests will be applied to evaluate both motor function and the cognitive performance of the participants.

Detailed description

This intervention protocol aims to validate five interactive applications for neurorehabilitation, as an effective therapeutic complement for the rehabilitation of children with unilateral cerebral palsy, compared to conventional rehabilitation. The intervention contemplates first a phase of application of standardized tests in the Cognitive enablement lab of the National Institute of pediatrics (INP) in Mexico City, to determine, among other things, if the patient meets the established inclusion criteria. Patients who meet these criteria will be randomly assigned to the control or experimental group. In the same INP, standardized tests will be applied to record their motor and cognitive capacity at the beginning of the protocol. Patients in the experimental group will receive two 50-minute video game rehabilitation sessions per week, for 10 weeks, under the supervision of trained personnel from the Laboratory of Applications for Neurorehabilitation (LANR). Control group patients will receive 10 weeks of occupational therapy, as prescribed by their treating physician. All standardized tests will be applied again to the participants of both groups after the 10 weeks of intervention, and again six months later, to measure the persistence of the changes. In the case of the experimental group, five interactive applications will be tested, each with a different sensor and virtual environment, as well as its own therapeutic objective, these applications are part of the National Autonomous University of Mexico (UNAM) virtual rehabilitation platform.

Conditions

• Cerebral Palsy, Spastic
• Hemiplegia, Spastic

Interventions

Type	Name	Description
DEVICE	Videogame therapy	There will be 5 video game-type applications for virtual therapy, each with a specific therapeutic objective, which will be administered by trained personnel, depending on the characteristics of each patient.
OTHER	Conventional therapy	Occupational therapy with different play materials

Timeline

• Start date: 2022-12-22
• Primary completion: 2025-05-01
• Completion: 2025-12-01
• First posted: 2022-09-28
• Last updated: 2024-05-07

Locations

1 site across 1 country: Mexico