search
Back to results

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

Primary Purpose

Cerebral Palsy, Spastic, Hemiplegia, Spastic

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Videogame therapy
Conventional therapy
Sponsored by
Universidad Nacional Autonoma de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic focused on measuring virtual rehabilitation, video games, motor function, spastic hemiparesis, cerebral palsy, unilateral spastic cerebral palsy

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto Nacional de PediatríaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Videogame therapy

Conventional therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Change in the digital version of the Corsi cube test.
Changes in working memory measured by the Corsi Cubes test.
Change in the digital version of the Perception of differences test (FACES)
Changes in visual perception, using the perception of differences test
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

Full Information

First Posted
September 21, 2022
Last Updated
January 3, 2023
Sponsor
Universidad Nacional Autonoma de Mexico
Collaborators
National Institute of Pediatrics, Mexico
search

1. Study Identification

Unique Protocol Identification Number
NCT05557305
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Nacional Autonoma de Mexico
Collaborators
National Institute of Pediatrics, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic, Hemiplegia, Spastic
Keywords
virtual rehabilitation, video games, motor function, spastic hemiparesis, cerebral palsy, unilateral spastic cerebral palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot, randomized, controlled, longitudinal trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Videogame therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Videogame therapy
Other Intervention Name(s)
Virtual rehabilitation
Intervention Description
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
Other
Intervention Name(s)
Conventional therapy
Other Intervention Name(s)
Occupational therapy
Intervention Description
Occupational therapy with different play materials
Primary Outcome Measure Information:
Title
Change in the Fugl-Meyer Assesment for upper extremity (FMUE)
Description
Level of motor deficit, evaluated using the Fugl-Meyer Assessment scale for the upper limb (0-66), with 66 meaning no defficit.
Time Frame
Baseline, 10 Weeks, 6 months
Title
Change in the Quality of Upper Extremity Skills Test (QUEST)
Description
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.
Time Frame
Baseline, 10 Weeks, 6 months
Secondary Outcome Measure Information:
Title
Change in the PedsQl pediatric quality of life questionnaire
Description
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.
Time Frame
Baseline, 10 Weeks, 6 months
Title
Change in the digital version of the Trail Making Test (TMT-A)
Description
Changes in cognitive function in terms of speed of executive functions and attention, measured by a digitized version of the Trail Making Test A.
Time Frame
Baseline, 10 Weeks, 6 months
Title
Change in the digital version of the Corsi cube test.
Description
Changes in working memory measured by the Corsi Cubes test.
Time Frame
Baseline, 10 Weeks, 6 months
Title
Change in the digital version of the Perception of differences test (FACES)
Description
Changes in visual perception, using the perception of differences test
Time Frame
Baseline, 10 Weeks, 6 months
Title
Change in the Digital implementation of the Go-NoGo paradigm.
Description
Changes in inhibition and flexibility functions, measured using a digital implementation of the Go-NoGo paradigm
Time Frame
Baseline, 10 Weeks, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana María Escalante-Gonzalbo, MCompSci
Phone
525556225730
Email
aescalan@ifc.unam.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Espinosa-Garamendi, PhD
Phone
525635280056
Email
eduardogaramendi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana María Escalante-Gonzalbo, MCompSci
Organizational Affiliation
National University of Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Pediatría
City
Mexico City
State/Province
Coyoacán, CDMX
ZIP/Postal Code
04530
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Maria Escalante-Gonzalbo, MCSc
Phone
5556225730
Email
aescalan@ifc.unam.mx

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34987304
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.
Results Reference
result
Links:
URL
http://lanr.ifc.unam.mx
Description
Web Page of the Research and Development Laboratory of Interactive Applications for Neuro-Rehabilitation (LANR) of the UNAM

Learn more about this trial

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

We'll reach out to this number within 24 hrs