INTERACT: INTERACT is an individualized, task-specific training program that includes environmental enrichment, natural and augmented realities, and active training.
Study 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
Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Kinematic assessment of manual reach — Initial assessment (two days before the intervention); final assesment (maximum five days after the intervention);retention phase assessment (two months after the end of the intervention). Data collection of reach movement will be conducted using the OpenCap software, which combines computer vision and musculoskeletal simulation to quantify human movement kinematics from videos captured using iPhones.
Disabilities of the Arm, Shoulder and Hand (DASH) — Initial assessment (two days before the intervention); final assesment (maximum five days after the intervention);retention phase assessment (two months after the end of the intervention). This questionnaire measures physical disability and symptoms in single or multiple upper limb disorders. The DASH requires that the participant answers the questions based on their perceived condition from the previous week. If the participant did not have the opportunity to perform any of the activities in the questionnaire, they are instructed to estimate which response would be the most accurate. It does not matter which hand or arm is used to perform the activity; the questions should be answered based on the ability, regardless of how the task is performed. Participants must respond by circling the answers from 1 to 5, where 1 = there was no difficulty and 5 = could not do it. The higher the score, the greater the motor inability to perform daily activities involving upper limbs.
Assessment of postural sway during the sit-to-stand movement and during functional reach in standing position — Initial assessment (two days before the intervention); final assesment (maximum five days after the intervention);retention phase assessment (two months after the end of the intervention). These analyses will be performed using the force platform. Sitting to standing analysis: the child will be positioned on a height-adjustable bench with the knees, ankles and hips at a 90º angle, the upper limbs crossed and supported on the chest and the feet on the force platform in a symmetrical manner. Functional reach: on the force platform, with the lower limbs aligned at hip width, and the child should reach as far as possible, moving the center of mass forward, without taking the feet off the platform and with the shoulders flexed at 90º.
Trial sites (1)
Facility
City
Region
Status
Federal University of São Carlos (UFSCar)
São Carlos
São Paulo
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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