Effect of Task-Specific Training in Augmented Reality Context (INTERACT Protocol) on Upper Limb Function and Activities in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Children with Cerebral Palsy (CP), a condition that affects movement and coordination, face difficulties in daily activities such as dressing, reaching for objects in high places, and getting up from seats. These challenges can negatively impact the quality of life for these children. Therefore, it is essential to seek effective treatments that help improve these skills. The use of technology in treatments, especially with games that utilize augmented reality (AR), has proven to be a good strategy. This technique aids motor learning, improving the skills that children struggle with while also increasing motivation, allowing them to engage in activities they enjoy. However, the application of AR in children with CP is still limited. In this context, it is crucial to provide appropriate treatments for these children, harnessing the benefits of AR technology. This study aims to investigate the effects of a protocol called INTERACT protocol, which consists of training activities that interest children, such as reaching for objects and getting up from a bench. These activities are linked to AR games and will be conducted with accessible equipment for children with CP, aiming to improve their quality of life. The children selected for the research will be divided into two groups: the experimental group (INTERACT) and the control group. This division will be done by random draw. The children in the control group will continue receiving the physiotherapy they are already undergoing for the same duration as the children in the INTERACT group. All children will participate in the treatment for 4 weeks, three times a week, with sessions lasting 1 hour and 20 minutes each. Our hypothesis is that the children participating in the INTERACT protocol will show improvements in activities involving reaching for objects and in the transition from sitting to standing.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: t
View:

• In the experimental and control groups, children who have been medically diagnosed with cerebral palsy, either unilateral or bilateral, with spasticity classification, will be included.

• Participants must be classified at GMFCS levels I and II, meaning they are capable of walking independently.

• The MACS (Manual Ability Classification System) should be between levels I (manipulates objects easily), II (manipulates most objects with reduced quality and speed), and III (manipulates objects with difficulty).

• The modified Ashworth score should be between 0 and 2.

• Ability to understand verbal commands and good comprehension of the proposed games.

Locations
Other Locations
Brazil
Federal University of São Carlos (UFSCar)
RECRUITING
São Carlos
Contact Information
Primary
Luana Gonçalves
luanapo@estudante.ufscar.br
(35) 98401-9229
Backup
Nelci Adriana Rocha
acicuto@ufscar.br
(16) 99449-4884
Time Frame
Start Date: 2024-05-21
Estimated Completion Date: 2026-11
Participants
Target number of participants: 34
Treatments
Experimental: Group INTERACT
The INTERACT group will participate in an intervention with augmented reality games. During the games, participants will perform hand and arm movements, as well as activities such as sitting and standing up from a chair or climbing and descending steps. The augmented reality software to be used, BRAINN\_XR, includes games such as puzzles and ping pong. The intervention will be conducted by physiotherapists trained in the use of the software. The sessions will take place three times a week, lasting 1 hour and 20 minutes, over a total period of 4 weeks.
No_intervention: Control group
Related Therapeutic Areas
Sponsors
Leads: Universidade Federal de Sao Carlos

This content was sourced from clinicaltrials.gov