Improving upper limb function in children with spastic cerebral palsy using augmented reality training

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

This study is testing whether using fun augmented reality games can help improve movement and daily activities for children with spastic cerebral palsy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 6 Years to 12 Years
• Sex: All
• Sponsor: Universidade Federal de Sao Carlos (other)
• Locations: 1 site (São Carlos, São Paulo)
• Trial ID: NCT06571929 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of the INTERACT protocol, which employs augmented reality (AR) games to enhance upper limb function and daily activities in children diagnosed with spastic cerebral palsy. The intervention focuses on task-specific training to improve motor skills and increase motivation through engaging activities. Children participating in the study will be assessed for their ability to perform tasks before and after the intervention to determine the effectiveness of AR in rehabilitation. The study aims to provide a novel approach to physiotherapy for children with CP, addressing their unique challenges in motor function.

Who should consider this trial

Good fit: Ideal candidates for this study are children with spastic cerebral palsy classified at GMFCS levels I and II, who can walk independently and have some ability to manipulate objects.

Not a fit: Children with dystonic tone classification, those at GMFCS levels III, IV, and V, or those with severe motor impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the daily functioning and quality of life for children with spastic cerebral palsy.

How similar studies have performed: While the application of augmented reality in rehabilitation is still emerging, existing literature suggests promising outcomes in improving motor function in similar populations.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Children with dystonic tone classification (identified by the Hypertonia Assessment Tool (HAT)), athetoid, or ataxic.
* GMFCS levels III, IV, and V.
* MACS levels IV and V.
* Modified Ashworth score of 3 to 4.
* Undergoing orthopedic surgical procedures within the past year.
* Receiving chemical blocks within the last 6 months.
* Deformities (muscle shortening and/or loss of joint mobility in the upper limbs) that prevent or compromise the ability to reach the midline.
* Presence of visual and/or auditory sensory deficits not corrected with devices.
* Use of medications that may alter muscle strength or tone.
* Cardiovascular limitations of any intensity, such as excessive fatigue, low exercise tolerance.
* Children who have undergone other intensive therapies within the past 6 months.
* Children with cognitive impairment indicated by caregivers or perceived by researchers due to difficulties in understanding verbal commands and virtual reality games.
* Children who do not accept playing augmented reality games.

Where this trial is running

São Carlos, São Paulo

• Federal University of São Carlos (UFSCar) — São Carlos, São Paulo, Brazil (RECRUITING)

Study contacts

• Study coordinator: Luana Gonçalves

Conditions: Cerebral Palsy, Spastic, Cerebral Palsy, Children, Games, Augmented reality