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

NCT05557305 | Recruiting

• 1 other identifier: 2022/054
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Spastic; Hemiplegia, Spastic

Keywords

virtual rehabilitation; video games; motor function; spastic hemiparesis; cerebral palsy; unilateral spastic cerebral palsy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Change in the PedsQl pediatric quality of life questionnaire

  Baseline, 10 Weeks, 6 months

• Change in the digital version of the Trail Making Test (TMT-A)

  Baseline, 10 Weeks, 6 months

• Change in the digital version of the Corsi cube test.

  Baseline, 10 Weeks, 6 months

• Change in the digital version of the Perception of differences test (FACES)

  Baseline, 10 Weeks, 6 months

• Change in the Digital implementation of the Go-NoGo paradigm.

  Baseline, 10 Weeks, 6 months

Study Arms (2)

Videogame therapy

EXPERIMENTAL

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

Conventional therapy

ACTIVE COMPARATOR

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

Interventions

Videogame therapy 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.

Also known as: Virtual rehabilitation

Videogame therapy

Conventional therapy OTHER

Occupational therapy with different play materials

Also known as: Occupational therapy

Conventional therapy

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead
• National Institute of Pediatrics, Mexico: collaborator

Study Sites (1)

Instituto Nacional de Pediatría

Mexico City, Coyoacán, CDMX, 04530, Mexico

RECRUITING

Related 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, 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.

  PMID: 34987304 RESULT

Related Links

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

MeSH Terms

Conditions

Cerebral Palsy; Hemiplegia

Interventions

Telerehabilitation; Occupational Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Ana María Escalante-Gonzalbo, MCompSci

  National University of Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana María Escalante-Gonzalbo, MCompSci

CONTACT

525556225730; aescalan@ifc.unam.mx

Eduardo Espinosa-Garamendi, PhD

CONTACT

525635280056; eduardogaramendi@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Laboratory of neurorehabilitation (LANR) IFC, UNAM

Model Details: Pilot, randomized, controlled, longitudinal trial

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 28, 2022
• Study Start: December 22, 2022
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)