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

NCT ID: NCT04483388

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-10-31

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group AB

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 Type: OTHER

Training with Virtual Reality

Intervention Type: OTHER

Computed virtual reality therapy was performed using the Nintendo Wii® console equipment. This system allows interaction with the player by means of a movement detection system and the representation of his avatar graphical representation of a user in virtual reality. It has a remote control with a wireless system, responsible for capturing the speed, direction , acceleration and deceleration of movement. The movements performed by the player are captured and reproduced on a screen via an infrared light sensor, positioned above the TV. The feedback given by the TV provides the movement itself observing opportunity in real time, generating positive reinforcement and facilitating training and improved task. The software used in this study was the Nintendo Wii Sports.

Conventional Training

Intervention Type: OTHER

It was done five types of exercises following to the protocol:

Exercise 1 (shoulder abduction); Exercise 2 (external rotation of the shoulder); Exercise 3 (elbow extension); Exercise 4 (weight transfer in upper limbs: a sitting position); Exercise 5 (function: task-oriented training).

Group BA

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 Type: OTHER

Training with Virtual Reality

Intervention Type: OTHER

Computed virtual reality therapy was performed using the Nintendo Wii® console equipment. This system allows interaction with the player by means of a movement detection system and the representation of his avatar graphical representation of a user in virtual reality. It has a remote control with a wireless system, responsible for capturing the speed, direction , acceleration and deceleration of movement. The movements performed by the player are captured and reproduced on a screen via an infrared light sensor, positioned above the TV. The feedback given by the TV provides the movement itself observing opportunity in real time, generating positive reinforcement and facilitating training and improved task. The software used in this study was the Nintendo Wii Sports.

Conventional Training

Intervention Type: OTHER

It was done five types of exercises following to the protocol:

Exercise 1 (shoulder abduction); Exercise 2 (external rotation of the shoulder); Exercise 3 (elbow extension); Exercise 4 (weight transfer in upper limbs: a sitting position); Exercise 5 (function: task-oriented training).

Interventions

Training with Virtual Reality

Computed virtual reality therapy was performed using the Nintendo Wii® console equipment. This system allows interaction with the player by means of a movement detection system and the representation of his avatar graphical representation of a user in virtual reality. It has a remote control with a wireless system, responsible for capturing the speed, direction , acceleration and deceleration of movement. The movements performed by the player are captured and reproduced on a screen via an infrared light sensor, positioned above the TV. The feedback given by the TV provides the movement itself observing opportunity in real time, generating positive reinforcement and facilitating training and improved task. The software used in this study was the Nintendo Wii Sports.

Intervention Type: OTHER

Conventional Training

It was done five types of exercises following to the protocol:

Exercise 1 (shoulder abduction); Exercise 2 (external rotation of the shoulder); Exercise 3 (elbow extension); Exercise 4 (weight transfer in upper limbs: a sitting position); Exercise 5 (function: task-oriented training).

Intervention Type: OTHER

Other Intervention Names

Training A; Training B

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role: lead

Responsible Party

Natália Feitoza do Nascimento

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Raquel Lindquist, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio Grande do Norte

References

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Other Identifiers

12649913.0.0000.5537

Identifier Type: -

Identifier Source: org_study_id