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The Effects of Virtual Reality Patients With Obstetric Brachial Plexus Injury

Primary Purpose

Obstetric Brachial Plexus Injury

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual reality treatment
conventional physiotherapy
Sponsored by
Emine Atıcı
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstetric Brachial Plexus Injury

Eligibility Criteria

4 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emine Atıcı

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Study Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Active Movement Scale
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.
Mallet Scoring System
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).
Normal Joint Range of Motion
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.

Secondary Outcome Measures

Full Information

First Posted
October 22, 2020
Last Updated
February 22, 2021
Sponsor
Emine Atıcı
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1. Study Identification

Unique Protocol Identification Number
NCT04605601
Brief Title
The Effects of Virtual Reality Patients With Obstetric Brachial Plexus Injury
Official Title
The Effects of Virtual Reality on Upper Extremity in Patients With Obstetric Brachial Plexus Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 24, 2019 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emine Atıcı

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Brachial Plexus Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Virtual reality treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Active Movement Scale
Description
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.
Time Frame
4 weeks
Title
Mallet Scoring System
Description
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).
Time Frame
4 weeks
Title
Normal Joint Range of Motion
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Emine Atıcı
City
Tuzla
State/Province
İstanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Virtual Reality Patients With Obstetric Brachial Plexus Injury

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