Effect of Task-Specific Training in an Augmented Reality Context on Upper Limb Function and Activities in Children With Spastic Cerebral Palsy
NCT Number: NCT06571929
Acronym: INTERACT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy, Spastic
Interventions: OTHER: INTERACT
Sponsor: Universidade Federal de Sao Carlos
Sex: ALL
Age: CHILD
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-21
Completion Date: 2026-11
Locations: Federal University of São Carlos (UFSCar), São Carlos, São Paulo, 13565-905, Brazil

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.

Primary Outcome Measures: Kinematic assessment of manual reach, 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., 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).|Disabilities of the Arm, Shoulder and Hand (DASH), 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., 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).|Assessment of postural sway during the sit-to-stand movement and during functional reach in standing position, 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., 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).
Secondary Outcome Measures: The Canadian Occupational Performance Measure (COPM), Identify individual goals, satisfaction and performance for the execution of the experimental treatment. Participants should rate satisfaction and performance on a scale from 0 to 10 in relation to the activities chosen by the child, with 0 = low satisfaction and low performance and 10 = very good performance and high satisfaction., Initial assessment (two days before the intervention); final assessment (maximum five days after the intervention)|Goal Attainment Scaling (GAS), It is described as a measure of individualized change, defining a set of unique goals for each person. The scoring scale reflects specific goals at five levels of achievement, ranging from -2 to +2, with -2 being much less than the expected outcome and +2 being much greater than the expected outcome., Initial assessment (two days before the intervention); intermediate assessment (after two weeks of training);final assessment (maximum five days after the intervention).|Pediatric Evaluation of Disability Inventory (PEDI - CAT), This instrument assesses functional abilities in four domains: (1) Activities of Daily Living; (2) Mobility; (3) Social/Cognitive; and (4) Responsibility. In this study, the Mobility domain will be used, which relates to the individual's performance in moving through various environments. After its application, the continuous score of the mobility domain will be used, which represents the child's current position along the function continuum and is not related to age., 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).|Challenge Test, The Challenge Test contains 25 items that assess gross motor function, related to speed, balance, and coordination.The total score is 112 points and can be defined as follows: scores from 0 to 2 refer to the ability to perform the task, while scores from 3 to 5 refer to the speed of the item, with a score of 4 being given when the individual performs the task in the best possible way., 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).|Dimensions of Mastery Questionnaire (DMQ), This questionnaire contains six subscales: 1) object-oriented persistence; 2) gross motor persistence; 3) social persistence with adults and peers; 4) negative reactions to failure; 5) pleasure in mastery and general competence; 6) instrumental and expressive mastery motivation.There are 45 items scored on a 5-point scale ranging from 1 = not at all like this child to 5 = exactly like this child. The total motivation score will be considered before and after 4 weeks of treatment. The higher the scores, the greater the motivation., 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).