Mobile Phone UseNCT04647799
Effect of Use Smartphone in Forward Head Position and Neutral Position on Upper Limbs Nerves
An observational study of Mobile Phone Use, run by MTI University at 1 site in Egypt.
Trial summary
To compare between two different positions (forward head position and neutral position) when using mobile phone by hand using nerve conduction velocity and F-wave of upper limb nerves ( ulnar, median and radial) in 4 different times. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mobile Phone Use
- What is being tested?
- smartphone
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2020to 10 Mar 2021
- Phase
- Observational
- 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: normal subjects
Who may be able to join
- Their ages range from 14-18 years.
- Not rolled on any regular athletic activity
Who cannot join
- Individual with neck pain
- Congenital deformity for upper limb
- Peripheral neuropathy due to diabetes mellitus type I
- Rheumatoid arthritis
- History of surgical intervention at nerves of the upper extremity
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Pysical Therapy, 6 Oct University
Cairo
About this study
Official title: Electrophysiological Studies Of Induced Forward Head Position And Hand Use Of Mobile Phone
To compare between two different positions (forward head position and neutral position) when using mobile phone by hand using nerve conduction velocity and F-wave of upper limb nerves ( ulnar, median and radial) in 4 different times.
Read the detailed description
PURPOSE:
- To compare between forward head position and hand use of mobile phone on conduction velocity of upper limb nerves
- To investigate the F responses of upper limbs nerves.
- To investigate the compound muscle action potential (CMAP) amplitudes of median nerves
BACKGROUND:
Forward head position may affect the cervical nerve root so it can also affect nerve conduction velocity due to continues stretch on nerves, also the over use of smart phone by hand may be affected the hand nerves, so this study determine which one of them has more influence than the other.
If the forward head position has the worst effect on the upper limb nerves investigators must avoid the incorrect position of the head to avoid stretch and compression of the nerves.
HYPOTHESES:
There are no statistical difference between forward head position and hand use of mobile phone on conduction velocity of the nerves of upper limb.
SUBJECTS:
Normal one hundred fifty non-athketic adolescents of both genders will participate in this study. Their age ranges from 14-18 years.
METHODS FOR ASSESSMENT
- Electromyography (EMG) will be used to measure nerve conduction velocity, F-wave, motor action potential
- Soft collar will used to fixed the craniovertebral angle during used mobile phone Universal goniometer
- Goniometer pro iPhone application
- Conditions
- Mobile Phone Use
- Being tested
- smartphone
- Medical subject headings
- Cell Phone Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smartphoneDevice
Also called mobile phone
Samsung A 71
| Study group | Role | What they receive |
|---|---|---|
| forward head position | nerve conduction velocity and f-wave applied to median , ulnar and radial nerve before and after 10,20 and 30 minutes in forward head position while Children will sit on chair with their feet on the ground without any tension, the upper limbs are rested in a table then, the angle between the line passing horizontally from the spinous process of C7 and the line passing between the tragus and spinous process of C7 will be measured by goniometer and goniometer pro application to evaluate the craniovertebral angle recording, we will fix the craniovertebral angle between 40.7° and 43.2°(severe FHP ) Receives: Device: smartphone | |
| neutral position | nerve conduction velocity and f-wave applied to median , ulnar and radial nerve before and after 10,20 and 30 minutes while Children will sit on chair with their feet on the ground with head in anatomical position, the upper are rested in a table and used both hand on touch screen of mobile phone Receives: Device: smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
motor and sensory nerve conduction velocity and f-wave in neutral position
motor and sensory nerve conduction velocity and f-wave will measured to nerves of upper extremities ( median, ulnar and radial nerves) in neutral position by using electrodiagnosis when using mobile phone
Measured: 1 day
Secondary outcomes (1)
motor and sensory nerve conduction velocity and f-wave measured in forward head position during use mobile phone
motor and sensory nerve conduction velocity and f-wave will measured to nerves of upper extremities ( median, ulnar and radial nerves) in forward head position by using electrodiagnosis when using mobile phone
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start10 Feb 2020
- Primary completion10 Feb 2021 (estimated)
- Study completion10 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobile Phone UseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Samy Ibrahim, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647799
- Sponsor's protocol ID
- 012/002542
- Status last verified
- Nov 2020
- First submitted
- 14 Sep 2020
- Last updated
- 1 Dec 2020
- Results posted
- 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 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Studies Of Induced Forward Head Position And Hand Use Of Mobile Phone
- ClinicalTrials.gov ID
- NCT04647799
- Acronym / sponsor ID
- 012/002542
- Conditions
- Mobile Phone Use
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 10 Feb 2021 (estimated)
- Study completion
- 10 Mar 2021 (estimated)
- First posted
- 1 Dec 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.
To compare between two different positions (forward head position and neutral position) when using mobile phone by hand using nerve conduction velocity and F-wave of upper limb nerves ( ulnar, median and radial) in 4 different times.
Detailed description
PURPOSE:
- To compare between forward head position and hand use of mobile phone on conduction velocity of upper limb nerves
- To investigate the F responses of upper limbs nerves.
- To investigate the compound muscle action potential (CMAP) amplitudes of median nerves
BACKGROUND:
Forward head position may affect the cervical nerve root so it can also affect nerve conduction velocity due to continues stretch on nerves, also the over use of smart phone by hand may be affected the hand nerves, so this study determine which one of them has more influence than the other.
If the forward head position has the worst effect on the upper limb nerves investigators must avoid the incorrect position of the head to avoid stretch and compression of the nerves.
HYPOTHESES:
There are no statistical difference between forward head position and hand use of mobile phone on conduction velocity of the nerves of upper limb.
SUBJECTS:
Normal one hundred fifty non-athketic adolescents of both genders will participate in this study. Their age ranges from 14-18 years.
METHODS FOR ASSESSMENT
- Electromyography (EMG) will be used to measure nerve conduction velocity, F-wave, motor action potential
- Soft collar will used to fixed the craniovertebral angle during used mobile phone Universal goniometer
- Goniometer pro iPhone application
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| forward head position | – | Device: smartphonenerve conduction velocity and f-wave applied to median , ulnar and radial nerve before and after 10,20 and 30 minutes in forward head position while Children will sit on chair with their feet on the ground without any tension, the upper limbs are rested in a table then, the angle between the line passing horizontally from the spinous process of C7 and the line passing between the tragus and spinous process of C7 will be measured by goniometer and goniometer pro application to evaluate the craniovertebral angle recording, we will fix the craniovertebral angle between 40.7° and 43.2°(severe FHP ) |
| neutral position | – | Device: smartphonenerve conduction velocity and f-wave applied to median , ulnar and radial nerve before and after 10,20 and 30 minutes while Children will sit on chair with their feet on the ground with head in anatomical position, the upper are rested in a table and used both hand on touch screen of mobile phone |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- normal subjects
Key inclusion criteria (2 listed)
- Their ages range from 14-18 years.
- Not rolled on any regular athletic activity
Key exclusion criteria (5 listed)
- Individual with neck pain
- Congenital deformity for upper limb
- Peripheral neuropathy due to diabetes mellitus type I
- Rheumatoid arthritis
- History of surgical intervention at nerves of the upper extremity
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 |
|---|---|---|
| smartphoneAlso: mobile phoneSamsung A 71 | Device | forward head position, neutral position |
Primary outcome
motor and sensory nerve conduction velocity and f-wave in neutral position
Time frame: 1 day
motor and sensory nerve conduction velocity and f-wave will measured to nerves of upper extremities ( median, ulnar and radial nerves) in neutral position by using electrodiagnosis when using mobile phone
1 secondary outcome
motor and sensory nerve conduction velocity and f-wave measured in forward head position during use mobile phone
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mobile Phone Use, run by MTI University at 1 site in Egypt.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Dec 2020. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karim s ibrahim, MSc (01124252525 ext. Egypt, karim.samy.Ebrahim@pt.mti.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
motor and sensory nerve conduction velocity and f-wave in neutral position (time frame: 1 day). 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 1 Dec 2020.