Lateralization of the Brain HemispheresNCT06497179
Effect of Handedness on Electromyographic Activity of Hand Muscles and Nerve Conduction Velocity During Use Mobil Phone in School Age Children
An observational study of Lateralization of the Brain Hemispheres, run by MTI University at 1 site in Egypt.
Trial summary
Asymmetries in both physiology and anatomy at different levels of the central nervous system, which controls the upper extremities, are well-established. These asymmetries, related to handedness, are evident in the motor cortex and corticospinal tract. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateralization of the Brain Hemispheres
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2024to 10 Sep 2024
- 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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Seventy adolescents (35 left-handed, 35 right-handed) aged 12 to 14 years, with normal BMI (16.5-24 kg/m²) and no regular athletic activity, participated. Participants shared the same socioeconomic level and used the same smartphone model (6.7-inch touchscreen).
Who may be able to join
- normal BMI (16.5-24 kg/m²)
- no regular athletic activity, participated.
- Participants shared the same socioeconomic level
- used the same smartphone model (6.7-inch touchscreen)
Who cannot join
- peripheral nerve injury
- upper extremity movement limitations
- history of upper extremity fractures or deformities,
- neurological disorders such as peripheral neuropathy due to type I diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Handedness on Electromyographic Activity of Hand Muscles and Nerve Conduction Velocity During Mobile Phone Use in School-age Children
Asymmetries in both physiology and anatomy at different levels of the central nervous system, which controls the upper extremities, are well-established. These asymmetries, related to handedness, are evident in the motor cortex and corticospinal tract. Moreover, variances have been identified in peripheral nervous pathways, including elevated sensory detection thresholds and increased conduction velocities in the motor nerve of the dominant arm.
Apart from disparities in the nervous system, differences also arise in the muscles. Prolonged preferential utilization of muscles on the dominant side of the body may lead to alterations in muscle fiber composition, characterized by a higher predominance of slow-twitch type I fibers.
Read more
Modern technology plays a key role in daily human life. This involves keeping pace with rapid changes in the field of communication technology. In this context, smartphones have become an essential part of life, not only in matters related to communication, but also as essential social accessories. As a result of this social involvement in communication technology, young children have become avid smartphones users. Holding a phone in hand needs support from fingers, flexion of hand and wrist, so holding the phone in same position for long periods can cause huge amount of stress on the structures present in the hand. This stress can cause injuries and damages in longer periods.
To address this objective, we will examine muscle synergies on the dominant sides in right-handed and left-handed participants while performing upper limb motor tasks. To accomplish this, we will conduct the following: Comparative analysis of motor and sensory nerve conduction velocities (radial, median, and ulnar) in right-handed and left-handed individuals during smartphone use. Comparison of hand muscle activation between right-handed and left-handed individuals during smartphone use.
Read the detailed description
Handedness is a well-recognized behavioral phenomenon characterized by a preference for using one hand over the other. This study investigates the impact of handedness on electromyographic (EMG) activity of hand muscles and nerve conduction velocity during smartphone use.
This interventional parallel study included 70 participants (35 left-handed, 35 right-handed) aged 12 - 14 years inclusion criteria: normal BMI (16.5-24 kg/m²) no regular athletic activity, Participants shared the same socioeconomic level used the same smartphone model (6.7-inch touchscreen).
Exclusion criteria included:
peripheral nerve injury upper extremity movement limitations history of upper extremity fractures or deformities, neurological disorders such as peripheral neuropathy due to type I diabetes mellitus.
EMG activity and nerve conduction velocities (radial, median, and ulnar nerves) will be measured before and during smartphone use. Muscle activation will be assessed for the abductor pollicis longus (APL), extensor carpi radialis (ECR), flexor carpi ulnaris (FCU), and first dorsal interosseous muscles. Statistical analysis will be conducted to identify significant differences between left-handed and right-handed participants.
- Conditions
- Lateralization of the Brain Hemispheres
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve Conduction Velocity
Nerves Assessed: Ulnar, median, and radial Phases: Phase 1: Pre-test without smartphone use. Phase 2: After 10 minutes of smartphone use. Consistency: Testing and laboratory environments will be kept constant. The same physiotherapist and neurophysiologist administered all tests. Measurements will be taken while participants used their dominant hand to operate the smartphone.
Measured: one day
maximum voluntary isometric contraction (MVIC)
Muscle Activation Assessment for Flexor carpi ulnaris (FCU), extensor carpi radialis (ECR), abductor pollicis longus (APL), and first dorsal interosseous muscle. Positioning: Participants will sit on a chair with feet on the ground. Coupling gel will be applied to electrodes, straps will be used to prevent movement and wires will be kept loose. EMG machine functionality will be checked prior to use. MVIC measures and evaluates muscle strength and normalizes EMG data. Procedure: Explained to parents beforehand, with measurements will take on the same day. Peak force and target muscle force will be analyzed for MVIC. Data Analysis: Average Rectified EMG (ARV) will be used to measure muscle activity, as it is less variable compared to peak EMG variables. Changes in EMG signal indicating muscle fatigue included increased mean absolute value, amplitude, duration of muscle action potential, and a shift to lower frequencies.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start10 Jul 2024
- Primary completion30 Aug 2024
- Study completion10 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateralization of the Brain HemispheresStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Nabil Hussein Mohamed, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497179
- Sponsor's protocol ID
- REC/211/MTI.PT/2406251
- Status last verified
- Sep 2024
- First submitted
- 4 Jul 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Handedness on Electromyographic Activity of Hand Muscles and Nerve Conduction Velocity During Mobile Phone Use in School-age Children
- ClinicalTrials.gov ID
- NCT06497179
- Acronym / sponsor ID
- REC/211/MTI.PT/2406251
- Conditions
- Lateralization of the Brain Hemispheres
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 10 Sep 2024 (estimated)
- First posted
- 11 Jul 2024 (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.
Asymmetries in both physiology and anatomy at different levels of the central nervous system, which controls the upper extremities, are well-established. These asymmetries, related to handedness, are evident in the motor cortex and corticospinal tract. Moreover, variances have been identified in peripheral nervous pathways, including elevated sensory detection thresholds and increased conduction velocities in the motor nerve of the dominant arm.
Apart from disparities in the nervous system, differences also arise in the muscles. Prolonged preferential utilization of muscles on the dominant side of the body may lead to alterations in muscle fiber composition, characterized by a higher predominance of slow-twitch type I fibers.
Modern technology plays a key role in daily human life. This involves keeping pace with rapid changes in the field of communication technology. In this context, smartphones have become an essential part of life, not only in matters related to communication, but also as essential social accessories. As a result of this social involvement in communication technology, young children have become avid smartphones users. Holding a phone in hand needs support from fingers, flexion of hand and wrist, so holding the phone in same position for long periods can cause huge amount of stress on the structures present in the hand. This stress can cause injuries and damages in longer periods.
To address this objective, we will examine muscle synergies on the dominant sides in right-handed and left-handed participants while performing upper limb motor tasks. To accomplish this, we will conduct the following: Comparative analysis of motor and sensory nerve conduction velocities (radial, median, and ulnar) in right-handed and left-handed individuals during smartphone use. Comparison of hand muscle activation between right-handed and left-handed individuals during smartphone use.
Detailed description
Handedness is a well-recognized behavioral phenomenon characterized by a preference for using one hand over the other. This study investigates the impact of handedness on electromyographic (EMG) activity of hand muscles and nerve conduction velocity during smartphone use.
This interventional parallel study included 70 participants (35 left-handed, 35 right-handed) aged 12 - 14 years inclusion criteria: normal BMI (16.5-24 kg/m²) no regular athletic activity, Participants shared the same socioeconomic level used the same smartphone model (6.7-inch touchscreen).
Exclusion criteria included:
peripheral nerve injury upper extremity movement limitations history of upper extremity fractures or deformities, neurological disorders such as peripheral neuropathy due to type I diabetes mellitus.
EMG activity and nerve conduction velocities (radial, median, and ulnar nerves) will be measured before and during smartphone use. Muscle activation will be assessed for the abductor pollicis longus (APL), extensor carpi radialis (ECR), flexor carpi ulnaris (FCU), and first dorsal interosseous muscles. Statistical analysis will be conducted to identify significant differences between left-handed and right-handed participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Seventy adolescents (35 left-handed, 35 right-handed) aged 12 to 14 years, with normal BMI (16.5-24 kg/m²) and no regular athletic activity, participated. Participants shared the same socioeconomic level and used the same smartphone model (6.7-inch touchscreen).
Key inclusion criteria (4 listed)
- normal BMI (16.5-24 kg/m²)
- no regular athletic activity, participated.
- Participants shared the same socioeconomic level
- used the same smartphone model (6.7-inch touchscreen)
Key exclusion criteria (4 listed)
- peripheral nerve injury
- upper extremity movement limitations
- history of upper extremity fractures or deformities,
- neurological disorders such as peripheral neuropathy due to type I diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nerve Conduction Velocity
Time frame: one day
Nerves Assessed: Ulnar, median, and radial Phases: Phase 1: Pre-test without smartphone use. Phase 2: After 10 minutes of smartphone use. Consistency: Testing and laboratory environments will be kept constant. The same physiotherapist and neurophysiologist administered all tests. Measurements will be taken while participants used their dominant hand to operate the smartphone.
maximum voluntary isometric contraction (MVIC)
Time frame: one day
Muscle Activation Assessment for Flexor carpi ulnaris (FCU), extensor carpi radialis (ECR), abductor pollicis longus (APL), and first dorsal interosseous muscle. Positioning: Participants will sit on a chair with feet on the ground. Coupling gel will be applied to electrodes, straps will be used to prevent movement and wires will be kept loose. EMG machine functionality will be checked prior to use. MVIC measures and evaluates muscle strength and normalizes EMG data. Procedure: Explained to parents beforehand, with measurements will take on the same day. Peak force and target muscle force will be analyzed for MVIC. Data Analysis: Average Rectified EMG (ARV) will be used to measure muscle activity, as it is less variable compared to peak EMG variables. Changes in EMG signal indicating muscle fatigue included increased mean absolute value, amplitude, duration of muscle action potential, and a shift to lower frequencies.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
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?
An observational study of Lateralization of the Brain Hemispheres, 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 4 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: status not confirmed, as of the sponsor's last update on 4 Sep 2024. 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?
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?
Nerve Conduction Velocity (time frame: one day). The study lists 2 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 4 Sep 2024.