Work-Related ConditionNCT04213352
A Comparison of Two Different Wrist Immobilization Methods
A study testing Wrist Splint and Rigid Taping in people with Work-Related Condition, run by Trakya University.
Trial summary
The aim of this study is to examine the effect of the splint and rigid taping on the muscle activation of the upper trapezius muscle during computer typing tasks in office workers. The study will be conducted on 10 healthy office workers. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Work-Related Condition
- What is being tested?
- Wrist Splint and Rigid Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2020to 15 Feb 2020
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being an office worker between 20-35 years of age
- Using a computer for at least 4 hours a day
- Working full time for at least 1 year without any upper extremity pathology
Who cannot join
- Having a body mass index of 30 kg / m2 or more on the day of evaluation
- Using muscle relaxants 72 hours before the evaluation
- Exercising within the last 48 hours
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Muscle Activation Of The Upper Trapezius During Computer Typing Task: A Comparison of Two Different Wrist Immobilization Methods
The aim of this study is to examine the effect of the splint and rigid taping on the muscle activation of the upper trapezius muscle during computer typing tasks in office workers.
The study will be conducted on 10 healthy office workers. The study subjects will be asked to type on a computer for 5 minutes (1) without splint or taping, (2) with a splint and (3) with rigid taping which limits the wrist flexion at the dominant side. The upper trapezius muscle activation will be recorded by surface EMG during the task. The mean values will be normalized according to Maximum Voluntary Isometric Contraction (MVIC) and %MVIC values.
- Conditions
- Work-Related Condition
- Being tested
- Wrist Splint, Rigid Taping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist SplintOther
Neutral position and volar supported wrist orthosis which limits the flexion and deviation while allowing pronation, supination, and extension of the wrist.
Rigid TapingOther
Rigid taping in the neutral position will be performed to allow pronation, supination, and extension of the wrist while limiting the flexion and deviation.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The subjects will be asked to type on a computer for 5 minutes without splint or taping. The upper trapezius muscle activation will be recorded by surface EMG during the task. The mean values will be normalized according to Maximum Voluntary Isometric Contraction (MVIC) and %MVIC values. |
| Splint Group | Experimental | The subjects will be asked to type on a computer for 5 minutes with a splint. The upper trapezius muscle activation will be recorded by surface EMG during the task. The mean values will be normalized according to Maximum Voluntary Isometric Contraction (MVIC) and %MVIC values. Receives: Other: Wrist Splint |
| Rigid Taping Group | Experimental | The subjects will be asked to type on a computer for 5 minutes with rigid taping which limits the wrist flexion at the dominant side. The upper trapezius muscle activation will be recorded by surface EMG during the task. The mean values will be normalized according to Maximum Voluntary Isometric Contraction (MVIC) and %MVIC values. Receives: Other: Rigid Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Muscle Activation for Control Group
Surface Electromyography (sEMG) device will be used for measurement of muscle activation. The electrodes going to be placed according to the SENIAM criteria(1). First, the MVIC will be performed by each individual in the manual muscle testing position. 6 seconds MVIC will be measured with 3 repetitions and a 3-minute rest period going to be given. The highest value of the three measurements will be recorded as MVIC. The computer task consists of typing 300-word text for 5 minutes. Individuals will be instructed about the typing task and to be seated comfortably and as close to screen as possible. The 5-minute typing task will be performed without orthosis or taping. The upper trapezius muscle activation will be recorded with the sEMG. The number of words participants wrote will be noted. To prevent muscle fatigue, a resting period of 5 minutes will be given. The mean values (mV) during the writing task with sEMG will be normalized according to MVIC and %MVIC values will be determined.
Measured: It will be recorded at baseline for MVIC and 1 minute after baseline while performing the 5-minute typing task on computer for %MVIC
Measurement of Muscle Activation for Splint Group
Surface Electromyography (sEMG) device will be used for measurement of muscle activation. The electrodes going to be placed according to the SENIAM criteria(1). First, the MVIC will be performed by each individual in the manual muscle testing position. 6 seconds MVIC will be measured with 3 repetitions and a 3-minute rest period going to be given. The highest value of the three measurements will be recorded as MVIC. The computer task consists of typing 300-word text for 5 minutes. Individuals will be instructed about the typing task and to be seated comfortably and as close to screen as possible. The 5-minute typing task will be performed with orthosis. The upper trapezius muscle activation will be recorded with the sEMG. The number of words participants wrote will be noted. To prevent muscle fatigue, a resting period of 5 minutes will be given. The mean values (mV) during the writing task with sEMG will be normalized according to MVIC and %MVIC values will be determined.
Measured: It will be recorded at baseline for MVIC and 1 minute after baseline while performing the 5-minute typing task on computer for %MVIC
Measurement of Muscle Activation for Rigid Taping Group
Surface Electromyography (sEMG) device will be used for measurement of muscle activation. The electrodes going to be placed according to the SENIAM criteria(1). First, the MVIC will be performed by each individual in the manual muscle testing position. 6 seconds MVIC will be measured with 3 repetitions and a 3-minute rest period going to be given. The highest value of the three measurements will be recorded as MVIC. The computer task consists of typing 300-word text for 5 minutes. Individuals will be instructed about the typing task and to be seated comfortably and as close to screen as possible. The 5-minute typing task will be performed with rigid taping. The upper trapezius muscle activation will be recorded with the sEMG. The number of words participants wrote will be noted. To prevent muscle fatigue, a resting period of 5 minutes will be given. The mean values (mV) during the writing task with sEMG will be normalized according to MVIC and %MVIC values will be determined.
Measured: It will be recorded at baseline for MVIC and 10 minutes after baseline while performing the 5-minute typing task on computer for %MVIC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start10 Jan 2020 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion15 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Work-Related ConditionStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halit SELÇUK, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213352
- Sponsor's protocol ID
- 31.10.2019/113
- Status last verified
- Dec 2019
- First submitted
- 23 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.
PubMed 11018445
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Activation Of The Upper Trapezius During Computer Typing Task: A Comparison of Two Different Wrist Immobilization Methods
- ClinicalTrials.gov ID
- NCT04213352
- Acronym / sponsor ID
- 31.10.2019/113
- Conditions
- Work-Related Condition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 10 Jan 2020 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 15 Feb 2020 (estimated)
- First posted
- 30 Dec 2019 (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.
The aim of this study is to examine the effect of the splint and rigid taping on the muscle activation of the upper trapezius muscle during computer typing tasks in office workers.
The study will be conducted on 10 healthy office workers. The study subjects will be asked to type on a computer for 5 minutes (1) without splint or taping, (2) with a splint and (3) with rigid taping which limits the wrist flexion at the dominant side. The upper trapezius muscle activation will be recorded by surface EMG during the task. The mean values will be normalized according to Maximum Voluntary Isometric Contraction (MVIC) and %MVIC values.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The subjects will be asked to type on a computer for 5 minutes without splint or taping. The upper trapezius muscle activation will be recorded by surface EMG during the task. The mean values will be normalized according to Maximum Voluntary Isometric Contraction (MVIC) and %MVIC values. |
| Splint Group | Experimental | Other: Wrist SplintThe subjects will be asked to type on a computer for 5 minutes with a splint. The upper trapezius muscle activation will be recorded by surface EMG during the task. The mean values will be normalized according to Maximum Voluntary Isometric Contraction (MVIC) and %MVIC values. |
| Rigid Taping Group | Experimental | Other: Rigid TapingThe subjects will be asked to type on a computer for 5 minutes with rigid taping which limits the wrist flexion at the dominant side. The upper trapezius muscle activation will be recorded by surface EMG during the task. The mean values will be normalized according to Maximum Voluntary Isometric Contraction (MVIC) and %MVIC values. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being an office worker between 20-35 years of age
- Using a computer for at least 4 hours a day
- Working full time for at least 1 year without any upper extremity pathology
Key exclusion criteria (3 listed)
- Having a body mass index of 30 kg / m2 or more on the day of evaluation
- Using muscle relaxants 72 hours before the evaluation
- Exercising within the last 48 hours
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 |
|---|---|---|
| Wrist SplintNeutral position and volar supported wrist orthosis which limits the flexion and deviation while allowing pronation, supination, and extension of the wrist. | Other | Splint Group |
| Rigid TapingRigid taping in the neutral position will be performed to allow pronation, supination, and extension of the wrist while limiting the flexion and deviation. | Other | Rigid Taping Group |
Primary outcome
Measurement of Muscle Activation for Control Group
Time frame: It will be recorded at baseline for MVIC and 1 minute after baseline while performing the 5-minute typing task on computer for %MVIC
Surface Electromyography (sEMG) device will be used for measurement of muscle activation. The electrodes going to be placed according to the SENIAM criteria(1). First, the MVIC will be performed by each individual in the manual muscle testing position. 6 seconds MVIC will be measured with 3 repetitions and a 3-minute rest period going to be given. The highest value of the three measurements will be recorded as MVIC. The computer task consists of typing 300-word text for 5 minutes. Individuals will be instructed about the typing task and to be seated comfortably and as close to screen as possible. The 5-minute typing task will be performed without orthosis or taping. The upper trapezius muscle activation will be recorded with the sEMG. The number of words participants wrote will be noted. To prevent muscle fatigue, a resting period of 5 minutes will be given. The mean values (mV) during the writing task with sEMG will be normalized according to MVIC and %MVIC values will be determined.
Measurement of Muscle Activation for Splint Group
Time frame: It will be recorded at baseline for MVIC and 1 minute after baseline while performing the 5-minute typing task on computer for %MVIC
Surface Electromyography (sEMG) device will be used for measurement of muscle activation. The electrodes going to be placed according to the SENIAM criteria(1). First, the MVIC will be performed by each individual in the manual muscle testing position. 6 seconds MVIC will be measured with 3 repetitions and a 3-minute rest period going to be given. The highest value of the three measurements will be recorded as MVIC. The computer task consists of typing 300-word text for 5 minutes. Individuals will be instructed about the typing task and to be seated comfortably and as close to screen as possible. The 5-minute typing task will be performed with orthosis. The upper trapezius muscle activation will be recorded with the sEMG. The number of words participants wrote will be noted. To prevent muscle fatigue, a resting period of 5 minutes will be given. The mean values (mV) during the writing task with sEMG will be normalized according to MVIC and %MVIC values will be determined.
Measurement of Muscle Activation for Rigid Taping Group
Time frame: It will be recorded at baseline for MVIC and 10 minutes after baseline while performing the 5-minute typing task on computer for %MVIC
Surface Electromyography (sEMG) device will be used for measurement of muscle activation. The electrodes going to be placed according to the SENIAM criteria(1). First, the MVIC will be performed by each individual in the manual muscle testing position. 6 seconds MVIC will be measured with 3 repetitions and a 3-minute rest period going to be given. The highest value of the three measurements will be recorded as MVIC. The computer task consists of typing 300-word text for 5 minutes. Individuals will be instructed about the typing task and to be seated comfortably and as close to screen as possible. The 5-minute typing task will be performed with rigid taping. The upper trapezius muscle activation will be recorded with the sEMG. The number of words participants wrote will be noted. To prevent muscle fatigue, a resting period of 5 minutes will be given. The mean values (mV) during the writing task with sEMG will be normalized according to MVIC and %MVIC values will be determined.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Results publication: PubMed 11018445Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Wrist Splint and Rigid Taping in people with Work-Related Condition, run by Trakya University.
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 3 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 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Halit SELÇUK, M.Sc., Ph.D. (c) (+905384855543, selcukhalit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Muscle Activation for Control Group (time frame: It will be recorded at baseline for MVIC and 1 minute after baseline while performing the 5-minute typing task on computer for %MVIC). 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?
On the ClinicalTrials.gov record for NCT04213352, which also lists 1 linked publication.
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 30 Dec 2019.