Cerebral Palsy, Spastic Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 84 |
Est. completion date | December 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility | Inclusion Criteria: - Outpatients - Both genders - Reside in Mexico City and the metropolitan area - Between 5 and 18 years old - With upper extremity hemiparesis caused by Unilateral Spastic Cerebral Palsy (USCP) on their dominant side or not - Who are at levels I-III of the Manual Ability Classification System for Children with Cerebral Palsy (MACS) - Score equal to or greater than 20 on the Fugl-Meyer upper extremity scale. Exclusion Criteria: - Patients with joint instability (shoulder, elbow, or wrist) - With severe concomitant medical problems such as congestive heart failure or seizures that prevent adequate attention to the task. - Severe aphasia - Hemineglect - Visual disturbances that are not corrected with glasses - Uncompensated hearing impairment - Inability to understand instructions (Token Test < 17) - Patients receiving concurrent therapies. |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional de Pediatría | Mexico City | Coyoacán, CDMX |
Lead Sponsor | Collaborator |
---|---|
Universidad Nacional Autonoma de Mexico | National Institute of Pediatrics, Mexico |
Mexico,
Escalante-Gonzalbo AM, Ramirez-Graullera YS, Pasantes H, Aguilar-Chale JJ, Sanchez-Castillo GI, Escutia-Macedo XA, Briseno-Soriano TM, Franco-Castro P, Estrada-Rosales AL, Vazquez-Abundes SE, Andrade-Morales D, Hernandez-Franco J, Palafox L. Safety, Feasi — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, 10 Weeks, 6 months | |
Primary | 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. | Baseline, 10 Weeks, 6 months | |
Secondary | 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. | Baseline, 10 Weeks, 6 months | |
Secondary | 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. | Baseline, 10 Weeks, 6 months | |
Secondary | Change in the digital version of the Corsi cube test. | Changes in working memory measured by the Corsi Cubes test. | Baseline, 10 Weeks, 6 months | |
Secondary | Change in the digital version of the Perception of differences test (FACES) | Changes in visual perception, using the perception of differences test | Baseline, 10 Weeks, 6 months | |
Secondary | 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 | Baseline, 10 Weeks, 6 months |
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