Obstetric Brachial Plexus InjuryNCT04605601
The Effects of Virtual Reality Patients With Obstetric Brachial Plexus Injury
A study testing Virtual reality treatment and conventional physiotherapy in people with Obstetric Brachial Plexus Injury, run by Emine Atıcı at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Obstetric Brachial Plexus Injury
- What is being tested?
- Virtual reality treatment and conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 May 2019to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obstetric Brachial Plexus Injury
- Being tested
- Virtual reality treatment, conventional physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality treatmentOther
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.
conventional physiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Not described Receives: Other: Virtual reality treatment |
| Control Group | Other | Not described Receives: Other: conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
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).
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start24 May 2019
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Brachial Plexus InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emine Atıcı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emine Atıcı, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605601
- Sponsor's protocol ID
- 001
- Status last verified
- Feb 2021
- First submitted
- 22 Oct 2020
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Virtual Reality on Upper Extremity in Patients With Obstetric Brachial Plexus Injury
- ClinicalTrials.gov ID
- NCT04605601
- Acronym / sponsor ID
- 001
- Conditions
- Obstetric Brachial Plexus Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Emine AtıcıUniversity, hospital or other
- Study start
- 24 May 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Virtual reality treatment |
| Control Group | Other | Other: conventional physiotherapy |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality treatmentTennis, 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. | Other | Study Group |
| conventional physiotherapyAs 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. | Other | Control Group |
Primary outcome
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.
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Obstetric Brachial Plexus Injury
Recruiting
Development of Diffusion MRI and Tractography Technique for the Detection of Nerve Lesions in Brachial Plexus Injuries
Obstetric Brachial Plexus Palsy
RecruitingObservational study
Evaluation of Pain, Upper Extremity Function, and Social Appearance Anxiety in Adults With Obstetric Brachial Plexus Palsy Who Underwent Shoulder Tendon Transfer Surgery
Brachial Plexus Birth Palsy, Brachial Plexus Palsy
RecruitingObservational study
Validity and Reliability of the Turkish Version of the Impact of Brachial Plexus Injury Questionnaire (IMBPIQ)
Brachial Plexus Birth Palsy, Brachial Plexus Palsy
Recruiting
Sensory Integration Therapy in Children With Congenital Brachial Plexus Injury: Developmental Outcomes
Obstetric Brachial Plexus Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality treatment and conventional physiotherapy in people with Obstetric Brachial Plexus Injury, run by Emine Atıcı at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active Movement Scale (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.