- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04605601
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
Status
Completed
Conditions
Intervention / Treatment
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
-
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İstanbul
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Tuzla, İstanbul, Turkey
- Emine Atıcı
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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.
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Experimental: Study Group
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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.
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4 weeks
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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).
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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.
Clinical Trials on Obstetric Brachial Plexus Injury
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All India Institute of Medical Sciences, New DelhiCompletedBrachial Plexus InjuryIndia
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Istanbul University - Cerrahpasa (IUC)CompletedBrachial Plexus Palsy | Obstetric; InjuryTurkey
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University of British ColumbiaChildren's & Women's Health Centre of British ColumbiaWithdrawnBirth Related Brachial Plexus Injury | Obstetrical Brachial Plexus Palsy
-
Centre Hospitalier Universitaire VaudoisWithdrawnBrachial Plexus InjurySwitzerland
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Atatürk UniversityNot yet recruitingBrachial Plexus Injury | Elasticity Imaging Techniques
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Assiut UniversityNot yet recruiting
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Siriraj HospitalLerdsin General HospitalCompleted
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University of AlbertaRoyal Alexandra Hospital; Glenrose FoundationNot yet recruiting
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Carilion ClinicEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingBrachial Plexus InjuryUnited States
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University of British ColumbiaChildren's & Women's Health Centre of British ColumbiaTerminated
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Taipei Medical University Shuang Ho HospitalCompleted
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Taipei Medical University Shuang Ho HospitalCompleted
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Abant Izzet Baysal UniversityRecruitingStroke | Upper Extremity Paralysis | Upper Extremity ParesisTurkey