Effect of Task-Specific Training in an Augmented Reality Context on Upper Limb Function and Activities in Children With Spastic Cerebral Palsy

Recruiting now · Not applicable

Conditions studied: Cerebral Palsy, Spastic

In brief

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.

Key facts

Study ID

NCT06571929

Run by

Universidade Federal de Sao Carlos

People needed

34

Starts

2024-05-21

Expected to finish

2026-11-01

Last updated by the study team

2024-08-26

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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