Training With Virtual Reality in Upper Arm Reaching of Children With Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: Training with Virtual Reality; Other: Conventional Training

• Registration Number: NCT04483388
• Lead Sponsor: Universidade Federal do Rio Grande do Norte

Brief Summary

The objective of this study was to evaluate the effects of training with Virtual Reality in the movement range of children with Cerebral Palsy spastic hemiparetic.The study protocol consisted of two days of training and 1 revaluation. The training A (Nintendo Wii®) and B (standard protocol) were randomized the children in AB and BA sequences, with one week interval. Immediately kinematics pre and post-training was held and after a week no significant changes were observed for the angular variables and space-time between groups. The Virtual Reality used for intervention to improve upper arm function in children with Cerebral Palsy is still a relatively new method.

Detailed Description

Introduction: The disability of upper limb function (MS) of children with Cerebral Palsy (CP) spastic hemiparetic restricts their participation in social activities. Virtual reality (VR) has shown promising results in functional recovery of this population, however, few studies have evaluated its effectiveness in the reaching of motion of these children. Objective: To assess the effects of training with VR in the movement range of children with CP spastic hemiparetic. Materials and Methods: We conducted a randomized crossover trial, where the sample consisted of 12 children diagnosed with CP hemiparetic, both genders, with a mean age of 9.63 ± 2.3 years. The sample description was performed by assessing muscle tone, range of motion, grip strength, functional performance and disability. Kinematic analysis of the upper limb was performed by Qualisys Motion Capture System®. The study protocol consisted of two days of training and 1 revaluation. The training A (Nintendo Wii®) and B (standard protocol) were randomized the children in AB and BA sequences, with one week interval. Immediately kinematics pre and post-training was held and after a week. Data were analyzed using SPSS 20.0 (Statistical Package for Social Science) assigning a 5% significance level. The kinematic variables were analyzed by two-way ANOVA for repeated measures.

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-02
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2020-07-20
• Last Update Submitted: 2020-07-20
• Study First Posted: 2020-07-23
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• A diagnosis of cerebral palsy spastic hemiparesis;
• Aged 6 to 12 years old;
• Preserved cognition to understand instructions;
• Present no significant auditory and visual deficits;
• The affected upper limb classified in levels II and III Rating System Manual (MACS, English Manual Abilities Classification System). The level II corresponds to children who are able to handle the majority of objects with low quality and / or speed of movement, while at level III are those that manipulate objects with difficulty and low speed, requiring assistance organization of activity. Spasticity ranked among the levels 0 and 3 of the Modified Scale Ashworth.It has not performed orthopedic surgeries, or have made use of botulinum toxin for less than six months, not presenting seizures, controlled medication.

Exclusion Criteria

• Presence of pain or discomfort during the course of the training;
• Refusal to follow commands and instructions and discontinuity of interventions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group AB	Conventional Training	After randomization, 6 children composed the AB sequence were initially submitted to experimental training with virtual reality and after a week, a period considered washout, the conventional training.
Group BA	Training with Virtual Reality	After randomization 6 children composed the BA sequence were initially submitted to conventional training and after a week, a period considered washout, the experimental training with virtual reality.
Group AB	Training with Virtual Reality	After randomization, 6 children composed the AB sequence were initially submitted to experimental training with virtual reality and after a week, a period considered washout, the conventional training.
Group BA	Conventional Training	After randomization 6 children composed the BA sequence were initially submitted to conventional training and after a week, a period considered washout, the experimental training with virtual reality.

Primary Outcome Measures

Name	Time	Method
Kinematic upper arm evaluation of children with cerebral palsy	4 months	We used a standardized 3D-analysis protocol to evaluate upper limb kinematic. The evaluation was divided into two stages: static collection and dynamics. In static collection, the patient was seated on a bench with feet on the floor, so that a 90 ° angle hip, knee and ankle joints. A table was positioned at a distance of 100% of the length of the affected upper arm and at the height of the xiphoid process and were used 19 mm reflective markers at the following points anatomical. In the dynamic evaluation, the participant continued to sit on the bench, with arms at the side of the torso, maintaining 90 ° elbow flexion and hand on the table was asked to touch a cube. All children started reach movement with the unaffected limb. Therefore, 15 reaches per child in each member in total and it was performed one minute intervals between attempts. The following variables: duration of movement, peak velocity and angular variation of shoulder and elbow.