Clinical trial NCT05557305: Changes in Motor and Cognitive Function on Unilateral Spastic Cerebral Palsy, Associated With Videogame Therapy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy, Spastic
Hemiplegia, Spastic
Keywords: virtual rehabilitation
video games
motor function
spastic hemiparesis
cerebral palsy
unilateral spastic cerebral palsy
Lead sponsor: Universidad Nacional Autonoma de Mexico
Sponsor class: OTHER
Collaborators: name: National Institute of Pediatrics, Mexico
First posted: 2022-09-28
Enrollment: 84
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot, randomized, controlled, longitudinal trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Fugl-Meyer Assesment for upper extremity (FMUE)
timeFrame: Baseline, 10 Weeks, 6 months
measure: Change in the Quality of Upper Extremity Skills Test (QUEST)
timeFrame: Baseline, 10 Weeks, 6 months
Secondary outcomes:
measure: Change in the PedsQl pediatric quality of life questionnaire
timeFrame: Baseline, 10 Weeks, 6 months
measure: Change in the digital version of the Trail Making Test (TMT-A)
timeFrame: Baseline, 10 Weeks, 6 months
measure: Change in the digital version of the Corsi cube test.
timeFrame: Baseline, 10 Weeks, 6 months
measure: Change in the digital version of the Perception of differences test (FACES)
timeFrame: Baseline, 10 Weeks, 6 months
measure: Change in the Digital implementation of the Go-NoGo paradigm.
timeFrame: Baseline, 10 Weeks, 6 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Pediatría
state: Coyoacán, CDMX
Study officials:
affiliation: National University of Mexico
name: Ana María Escalante-Gonzalbo, MCompSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, Feasibility, and Acceptability of a New Virtual Rehabilitation Platform: A Supervised Pilot Study. Rehabil Process Outcome. 2021 Aug 7;10:11795727211033279. doi: 10.1177/11795727211033279. eCollection 2021.