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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05557305
• Other study ID #: 2022/054
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2022
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Universidad Nacional Autonoma de Mexico
• Contact: Ana María Escalante-Gonzalbo, MCompSci
• Phone: 525556225730
• Email: aescalan[@]ifc.unam.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Hemiplegia
• Hemiplegia, Spastic
• Muscle Spasticity
• Paralysis

Intervention

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

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Pediatría	Mexico City	Coyoacán, CDMX

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Nacional Autonoma de Mexico	National Institute of Pediatrics, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

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

Outcome

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

External Links

•   Web Page of the Research and Development Laboratory of Interactive Applications for Neuro-Rehabilitation (LANR) of the UNAM