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

May 6, 2024 updated by: Ana María Escalante Gonzalbo, Universidad Nacional Autonoma de Mexico

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ana María Escalante-Gonzalbo, MCompSci
  • Phone Number: 525556225730
  • Email: aescalan@ifc.unam.mx

Study Contact Backup

Study Locations

  • Mexico
    • Coyoacán, CDMX
      • Mexico City, Coyoacán, CDMX, Mexico, 04530
        • Recruiting
        • Instituto Nacional de Pediatría
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Videogame therapy
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
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 Names:
  • Virtual rehabilitation
Active Comparator: Conventional 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
Occupational therapy with different play materials
Other Names:
  • Occupational therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Fugl-Meyer Assesment for upper extremity (FMUE)
Time Frame: Baseline, 10 Weeks, 6 months
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
Change in the Quality of Upper Extremity Skills Test (QUEST)
Time Frame: Baseline, 10 Weeks, 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the PedsQl pediatric quality of life questionnaire
Time Frame: Baseline, 10 Weeks, 6 months
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
Change in the digital version of the Trail Making Test (TMT-A)
Time Frame: Baseline, 10 Weeks, 6 months
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
Change in the digital version of the Corsi cube test.
Time Frame: Baseline, 10 Weeks, 6 months
Changes in working memory measured by the Corsi Cubes test.
Baseline, 10 Weeks, 6 months
Change in the digital version of the Perception of differences test (FACES)
Time Frame: Baseline, 10 Weeks, 6 months
Changes in visual perception, using the perception of differences test
Baseline, 10 Weeks, 6 months
Change in the Digital implementation of the Go-NoGo paradigm.
Time Frame: Baseline, 10 Weeks, 6 months
Changes in inhibition and flexibility functions, measured using a digital implementation of the Go-NoGo paradigm
Baseline, 10 Weeks, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional Autonoma de Mexico

Collaborators

National Institute of Pediatrics, Mexico

Investigators

  • Principal Investigator: Ana María Escalante-Gonzalbo, MCompSci, National University of Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2022

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 21, 2022

First Submitted That Met QC Criteria

September 23, 2022

First Posted (Actual)

September 28, 2022

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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