An interventional study of Videogame therapy and Conventional therapy in Cerebral Palsy, Spastic and Hemiplegia, Spastic, sponsored by Universidad Nacional Autonoma de Mexico. Recruiting at 1 site in Mexico. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by Universidad Nacional Autonoma de Mexico · Not applicable, Interventional, and Treatment
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.
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.
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's planned enrollment of 84 is above the median of 36 across 525 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Universidad Nacional Autonoma de Mexico is the lead sponsor of 28 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
The participants of the experimental group will only undergo video game therapy and will be called twice a week to perform supervised video game rehabilitation therapy, for a period of 45-50 minutes per session, for 10 weeks
Device: Videogame therapy
The participants in the control group will undergo the conventional therapy prescribed by their treating physician, at the INP they are prescribed occupational therapy, which is usually focused on game activities with balls, dice, cubes, tying ropes, etc., twice a week for 10 weeks.
Other: Conventional 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.
Also known as: Virtual rehabilitation
Occupational therapy with different play materials
Also known as: Occupational therapy
Change in the Fugl-Meyer Assesment for upper extremity (FMUE)
Level of motor deficit, evaluated using the Fugl-Meyer Assessment scale for the upper limb (0-66), with 66 meaning no defficit.
Time frame: Baseline, 10 Weeks, 6 months
Change in the Quality of Upper Extremity Skills Test (QUEST)
Upper limb motor skill level, obtained through the Quality of Upper Extremity Skills Test (less than 0 to 100), with 100 being the best quality of movement.
Time frame: Baseline, 10 Weeks, 6 months
Change in the PedsQl pediatric quality of life questionnaire
Level of independence in performing activities of daily living (ADLs), assessed using the PedsQl pediatric quality of life questionnaire (0-132) with 0 as the highest score.
Time frame: Baseline, 10 Weeks, 6 months
Change in the digital version of the Trail Making Test (TMT-A)
Changes in cognitive function in terms of speed of executive functions and attention, measured by a digitized version of the Trail Making Test A.
Time frame: Baseline, 10 Weeks, 6 months
Change in the digital version of the Corsi cube test.
Changes in working memory measured by the Corsi Cubes test.
Time frame: Baseline, 10 Weeks, 6 months
Change in the digital version of the Perception of differences test (FACES)
Changes in visual perception, using the perception of differences test
Time frame: Baseline, 10 Weeks, 6 months
Change in the Digital implementation of the Go-NoGo paradigm.
Changes in inhibition and flexibility functions, measured using a digital implementation of the Go-NoGo paradigm
Time frame: Baseline, 10 Weeks, 6 months
Plan to share: No
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Universidad Nacional Autonoma de Mexico