Autonomic heart modulation in children and adolescents with Cerebral Palsy during task using virtual Technology

Not Applicable

• Conditions: children; adolescents; Cerebral Palsy; C10.228.140.140.254; M01.060.406; M01.060.057

• Registration Number: RBR-92r54q
• Lead Sponsor: niversidade Federal de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-25
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Children and adolescents of both groups should be aged from 5 to 21 years old, also they must have a clear understand of the proposed activities. Statement of informed consent will be signed by a legal guardian. All participants from the experimental group (GCP) should have diagnosis of cerebral palsy. Additionally, they should be classified at levels I, II, or III of the Manual Ability Classification System (MACS). To standardizes the sample according to ICF, participants with CP should present musculoskeletal functions in the mobility of several joints of the upper limbs with mild and moderate deficiencies (b7101.1 and b7101.2), trunk muscle tonus with mild deficiency (b7355.1) and mild or moderate upper limb tonus (b7358.1 and b7358.2). Regarding to learning, application of knowledge, accomplishment of tasks and communication all individuals will have light deficits in concentration and attention (d160.11), in performing a simple task (d2100.11) and in receiving oral messages (d310.11). These domains were chosen because they are the most important to enable the execution of the proposed task of touching the computer key at the exact moment or enabling to move towards the virtual environment.

Exclusion Criteria

Children that have undergone surgical procedures or has taken neurolytic block 12 months prior to the training sessions will be not included in the present research. Children with Gross Motor Function Classification System (GMFCS) level V (most severe CP) or who have severe visual or hearing impairments, or photosensitive epilepsy will be excluded. Furthermore, children with other pathologies and secondary disabilities will also be excluded, such as orthopedic deformity with indication for surgery, Epilepsy, Metal implant in the skull or use of hearing aids. ?

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected Outcomes 1: Children and adolescents with Cerebral Palsy (CP) have presented lower heart rate variability (HRV) compared to control group, with tendency to increase the HRV during the practice of Virtual Reality (VR) tasks assessed by heart rate variability indices. Furthermore, children and adolescents with CP that have shown more impaired functionality and participation have shown also greater impairment in the HRV indexes.<br>

Secondary Outcome Measures

Name	Time	Method
Expected Outcomes 2: Interactive devices more abstract (without physical touch - more virtual) allowed better performance on task when compared to more concrete devices (with physical touch) in the CP group. Additionally, the performance of children and adolescents with CP during virtual tasks were lower compared to children with typical development. Regarding to the the functional profile and participation of children and adolescents with CP, these people have lower participation and engagement in activities compared to their peers.<br>