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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-22

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cerebral Palsy, Spastic Hemiplegia, Spastic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot, randomized, controlled, longitudinal trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Videogame therapy

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

Conventional therapy

Intervention Type OTHER

Occupational therapy with different play materials

Interventions

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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.

Intervention Type DEVICE

Conventional therapy

Occupational therapy with different play materials

Intervention Type OTHER

Other Intervention Names

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Virtual rehabilitation Occupational therapy

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No