The Effects of Virtual Reality Patients With Obstetric Brachial Plexus Injury

February 22, 2021 updated by: Emine Atıcı

The Effects of Virtual Reality on Upper Extremity in Patients With Obstetric Brachial Plexus Injury

Obstetric brachial plexus injury is the flask paralysis of the arm, which emerges from a difficult birth. This results from the damage to the nerves from the C5 cervical root to T1. Following brachial plexus injury, movement impairment, a decrease in the joint range of motion, muscle contractures, motor disorders related to muscle weakness, and the loss of functional movements are commonly observed. Many rehabilitation programs for the upper extremity aim at developing functional improvement in addition to increasing the active range of motion of the related limb in children with Obstetric brachial plexus injury. Obstetric brachial plexus injury treatment includes both conservative and surgical interventions. The first intervention in all the Obstetric brachial plexus injury cases is conservative. In recent years, supporting the treatment with virtual reality exercises in addition to the conventional brachial plexus rehabilitation is a method being tested. The use of virtual reality treatment in physiotherapy and rehabilitation has substantially increased within the last 6-7 years. Virtual reality is a method that enables working with task-based techniques by creating stimulating and entertaining environments and especially using children's interest and motivation. Nintendo Wii, which is used in the virtual reality treatment, is a device that can be controlled wirelessly, consists of a system console, remote control for activity control, and a sensor perceiving the change in movements, and a display screen, and gives the opportunity to work with the person individually. The aim of this study is to investigate the effects of the conventional physiotherapy approach and virtual reality applications with Nintendo Wii, applied additionally in this study, on upper extremity functions in children with obstetric brachial plexus injury. They can directly be mentioned as the effects on muscle strength, normal joint range of motion, and functionality.

Study Overview

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • İstanbul
      • Tuzla, İstanbul, Turkey
        • Emine Atıcı

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • undergone primary or -if available- secondary surgery at least 6 months before
  • Being between the ages of 5-13
  • be affected by the C5-C6 (upper truncus)

Exclusion Criteria:

  • Patients with severe cognitive functional disorder
  • Patients with cognitive functions inadequate for communication
  • Patients with any neurological problems
  • Patients who have a contracture preventing the upper extremity joints from performing activities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Group
As the conventional physiotherapy, neuromuscular electrical stimulation and strengthening exercises for the deltoid, infraspinatus, triceps, biceps, supinator, and wrist extensor muscles, and passive, active, active assistive joint Rage of Motion, and stretching exercises for the shoulder, elbow and wrist joints are applied to the patients in the standardized program for the upper extremity in 10 repetitions.
Experimental: Study Group
Tennis, boxing, and baseball games of the Wii Sports package sre used for activating the upper extremity functions of the patients. In the tennis game, patients represent people holding rackets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active Movement Scale
Time Frame: 4 weeks
The Active Movement Scale, developed by Clarke and Curtis, was specifically developed for children with neonatal (between the ages of 0-1) obstetric brachial plexus palsy, and it was developed as a scoring system that consists of eight sequential steps and can numerically measure the upper extremity strength. It allows for scoring against gravity and in positions with the elimination of gravity in the score interval of "0-7" for 15 joint movements in the upper extremity. While scoring the joint movement in the position with the elimination of gravity in the score interval of "0-4", the same movement is repeated in children who can receive "4" against gravity, and the score interval of "5-7" is evaluated. The advantage of the Active Movement Scale is its frequent use in this field and its applicability until adolescence.
4 weeks
Mallet Scoring System
Time Frame: 4 weeks
Another way of evaluating children with Obstetric Brachial Plexus Injury is the Mallet Scoring System. The Mallet Scoring System is often used for evaluating the shoulder function. Since the child needs to perform the desired movements actively, it is more appropriate to use this scale in children older than 3-4 years of age. The patient is expected to actively perform 5 different shoulder movements such as shoulder abduction, moving the hand towards the head, back, and mouth. Each movement is assessed between 1 and 5 (1st degree: Total paralysis, 5th degree: normal joint shoulder movement).
4 weeks
Normal Joint Range of Motion
Time Frame: 4 weeks
In our study, the active and passive shoulder flexion, abduction and internal-external rotation, elbow flexion, forearm supination-pronation, and wrist flexion-extension of all the patients on the affected side are evaluated in the supine position before and after the treatment. The limited movements of the upper extremity were measured using a digital goniometer.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2019

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 28, 2020

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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