Muscle FatigueNCT05077046
Efficacy of an Ergonomic Handwriting Pen - The AWP Pen Study
A study testing Ergonomic handwriting pen in people with Muscle Fatigue, run by University of Applied Sciences for Health Professions Upper Austria at 1 site in Austria.
Trial summary
This clinical investigation is a monocenter, prospective, randomized, controlled, counter-balanced, two-arm study investigating the effect of a novel ergonomic handwriting pen. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Fatigue
- What is being tested?
- Ergonomic handwriting pen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteAustria
- Study dates
- 27 Sep 2021to 8 Oct 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent
- People aged between 18 and 50 years
- People free of acute or chronical diseases limiting their handwriting capabilities (e.g. Parkinson, hand/arm amputee)
- Education level: at least high school diploma
- People using a handwriting pen > once per week
- Sufficient German language skills (min. B2 level - Questionnaire language)
Who cannot join
- People with mental disorders limiting their writing performance
- People with chronical fatigue syndrome
- People incapable of concentrating on tasks for more than 30 minutes
- Non-corrected visual disturbances
Trial locations and contacts
1 site in 1 country.
Austria1 site
University of Applied Sciences for Health Professions Upper Austria
Linz, Upper Austria, 4020
About this study
Official title: Efficacy of an Ergonomic Handwriting Pen - a Monocenter Randomized Controlled Counter-balanced Trial
This clinical investigation is a monocenter, prospective, randomized, controlled, counter-balanced, two-arm study investigating the effect of a novel ergonomic handwriting pen.
Read the detailed description
Background:
Extended and prolonged handwriting activities can be exhausting for the writer and can lead to muscle cramps, irritations in the hand and lower arm as well as high pressures in the fingers and pain. As muscle pain in the upper extremities can affect hand writing quality, and as it is well known that high tendon activities and tissue pressures can lead to health issues, there is a need for ergonomic handwriting materials, especially for people with prolonged and extended handwriting activities (e.g. students).
Despite the high number of ergonomic handwriting pens on the market, clinical or scientific investigations for such pens are very rare. Indeed only a few studies on such pens are available, and there is little knowledge on how ergonomics can impact physiological and performance parameters. As high forces and pressures in the hand region over a long period of time can lead to health issues, a pen design targeting the reduction of grip forces and pressures was developed.
To investigate if this pen design can affect handwriting performance, perceived fatigue, pen and discomfort, the AWP pen study was developed. To follow international recommendations and to reduce potential bias as well as interpersonal variation, this study was designed as randomized controlled counter-balanced trial. The insights of this study can further help to develop novel handwriting tools and to support people with handwriting disabilities (e.g. stroke patients).
Methods:
The study consists of one assessment day / visit only. During this visit and after proving the study eligibility (inclusion / exclusion criteria), half of the study participants will randomly be allocated to one of two study groups. Depending on the group allocation participants will either execute the first assessment trial with an ergonomic (= intervention) or common (= control) handwriting pen. The randomization will be realized with opaque envelopes created by an external and independent person.
Overall participants will execute the identical assessment trial / test battery with the control and the intervention pen. Each assessment trial consists of writing speed and accuracy tasks, followed by the "Handwriting Assessment Battery for Adults" (HAB) and a fatigue task. These assessments are followed by Visual Analogue Scales and a questionnaire.
Due to the counter-balanced design and the fatigue tasks, the break between both assessment trials will take at least 20 minutes to ensure similar baseline conditions for both pens. The influence of incomplete fatigue recovery as well as practice effects will be reduced by the counter-balanced design.
The overall duration of study participation ranges between 2.5 and 4 hours.
- Conditions
- Muscle Fatigue
- Being tested
- Ergonomic handwriting pen
- Keywords
- Office Work, Handwriting Performance, Pain, Discomfort
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergonomic handwriting penOther
An ergonomic handwriting pen called AWP-pen designed to reduce perceived muscle fatigue, finger tip pressure and discomfort during handwriting activities.
| Study group | Role | What they receive |
|---|---|---|
| Intervention first arm | Experimental | Due to the counter-balanced design of this study all participants will experience both an interventional and a control period. Within the "intervention first arm" participants will be asked to execute the assessment trial / test battery with the intervention pen first. After a wash-out period, the participants will execute the same assessment trial / test battery with the control pen. Receives: Other: Ergonomic handwriting pen |
| Control first arm | Experimental | Due to the counter-balanced design of this study all participants will experience both an interventional and a control period. Within the "control first arm" participants will be asked to execute the assessment trial / test battery with the control pen first. After a wash-out period, the participants will execute the same assessment trial / test battery with the intervention pen. Receives: Other: Ergonomic handwriting pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjectively perceived muscle fatigue changes as determined with a Visual Analogue Scale (VAS)
Subjects will rate their subjectively perceived muscle fatigue prior and after the test battery by means of a Visual Analogue Scale (VAS). The VAS used for this study ranges from 0 (none) to 100 (strongly pronounced) points.
Question:
How would you describe your current muscle fatigue in your writing hand?
Measured: 1 experimental day
Subjectively perceived discomfort as determined with a Visual Analogue Scale (VAS)
Subjects will rate their subjectively perceived discomfort in the writing hand prior and after the test battery by means of a Visual Analogue Scale (VAS). The VAS used for this study ranges from 0 (none) to 100 (strongly pronounced) points.
Question:
How would you describe your current discomfort in the writing hand?
Measured: 1 experimental day
Secondary outcomes (9)
Muscle pain estimated as determined with a Visual Analogue Scale (VAS)
Subjects will rate their subjectively perceived discomfort in the writing hand prior and after the test battery by means of a Visual Analogue Scale (VAS). The VAS used for this study ranges from 0 (none) to 100 (strongly pronounced) points.
Question:
How would you rate the current pain in the writing hand?
Measured: 1 experimental day
Handwriting speed as determined with a maze task (accuracy based)
Within this assessments, participants are asked to follow a predefined maze task. Overall, the same maze is used twice in different sizes to realize a progressive difficulty. In addition, as muscle fatigue can affect handling accuracy, the most difficult / accuracy maze task is to be put first in the study procedure.
The test instruction is:
"Cross the maze as accurately as possible without any time pressure".
In addition to a detailed test instruction, two practice mazes have to be executed by the test subjects and supervised by a study member.
The handling speed (time required to pass the whole maze) as well as the number of errors (lines outside the walls) will be recorded and analyzed by a study member.
Measured: 1 experimental day
Handwriting speed as determined with a maze task (speed and accuracy based)
Within this assessments, participants are asked to follow a predefined maze task. Overall, the same maze is used three times in different sizes to realize a progressive difficulty. In addition, as muscle fatigue can affect handling accuracy, the most difficult / accuracy maze task is to be put first in the study procedure.
The test instruction is:
"Cross the maze as soon as possible, but do not touch the walls";
In addition to a detailed test instruction, two practice mazes have to be executed by the test subjects and supervised by a study member.
The handling speed (time required to pass the whole maze) as well as the number of errors (lines outside the walls) will be recorded and analyzed by a study member.
Measured: 1 experimental day
Handwriting speed as determined with a dot in cycle task
One working speed test - named dot in cycle task - is part of the study procedure. Within this test, participants are asked to draw as many dots in a cluster of cycles as possible. This test has already been used for research, and it is characterized by a very easy design.
The test instructions for this test are:
"Fill in as many dots in the middle of the cycles as possible. Work as fast and accurate as possible. Work from the left to right, beginning in the upper left corner."
Similar to the maze tasks, the dot in cycle task consist of a detailed test instruction, the test itself as well as two practice tasks. The execution of these practice tasks must be supervised by a study member to:
- ensure that the test subject fully understood the tasks,
- get the possibility to clarify some uncertainties when the test tasks exhibit some uncertainties,
- reduce practice effects that will occur on the regular task.
Measured: 1 experimental day
Handwriting speed as determined with a fatigue task
The fatigue task is a simple writing task implemented to induce muscle fatigue. Within this task the test subject is asked to copy a predefined text passage by using the corresponding study pen. As noticeable fatigue occurs only after a certain writing time and intensity, this copying process will last for 15 minutes. In addition, the test subjects are asked to copy as many words as possible within this time frame.
Measured: 1 experimental day
Positioning accuracy as determined with a maze task (accuracy based)
Within this assessments, participants are asked to follow a predefined maze task. Overall, the same maze is used twice in different sizes to realize a progressive difficulty. In addition, as muscle fatigue can affect handling accuracy, the most difficult / accuracy maze task is to be put first in the study procedure.
The test instruction is:
"Cross the maze as accurately as possible without any time pressure".
In addition to a detailed test instruction, two practice mazes have to be executed by the test subjects and supervised by a study member.
The handling speed (time required to pass the whole maze) as well as the number of errors (lines outside the walls) will be recorded and analyzed by a study member.
Measured: 1 experimental day
Positioning accuracy as determined with a maze task (speed and accuracy based)
Within this assessments, participants are asked to follow a predefined maze task. Overall, the same maze is used three times in different sizes to realize a progressive difficulty. In addition, as muscle fatigue can affect handling accuracy, the most difficult / accuracy maze task is to be put first in the study procedure.
The test instruction is:
"Cross the maze as soon as possible, but do not touch the walls";
In addition to a detailed test instruction, two practice mazes have to be executed by the test subjects and supervised by a study member.
The handling speed (time required to pass the whole maze) as well as the number of errors (lines outside the walls) will be recorded and analyzed by a study member.
Measured: 1 experimental day
Handwriting performance as determined with the Handwriting Assessment Battery for Adults (HAB)
The "Handwriting Assessment Battery for Adults" is a standardized handwriting assessment exhibiting high intraclass correlations and standardized values for different cohorts. It consists of three main sections containing several items estimating:
- Pen Control \& Manipulation
- Writing Speed
- Writing Legibility
For the Handwriting Assessment Battery predefined guidelines for data analysis exist.
Measured: 1 experimental day
Usability as determined with a non-standardized questionaire
The questionnaires used in this study are non-standardized questionnaires consisting of questions with nominal (e.g. yes/no), ordinal (e.g. significantly worse, worse, identical, better, significantly better) or open answers (e.g. "Please state the pros of the product you used in this study"). They were developed to estimate the user experience and satisfaction with the product under investigation as well as its usability. Apart from the regular questions, the questionnaires include a short introduction as well as brief instructions on how to complete them.
Measured: 1 experimental day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start27 Sep 2021
- Primary completion8 Oct 2021
- Study completion8 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle FatigueStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences for Health Professions Upper Austria
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Milwaukee
- Responsible party
- Sponsor
- Investigators
- Bernhard Schwartz, Dr. MSc BSc, Principal investigator, University of Applied Sciences for Health Professions Upper Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077046
- Sponsor's protocol ID
- AWP-Pen 001
- Status last verified
- Nov 2021
- First submitted
- 19 Sep 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Ergonomic Handwriting Pen - a Monocenter Randomized Controlled Counter-balanced Trial
- ClinicalTrials.gov ID
- NCT05077046
- Acronym / sponsor ID
- AWP-Pen 001
- Conditions
- Muscle Fatigue
- Keywords
- Office Work, Handwriting Performance, Pain, Discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Applied Sciences for Health Professions Upper AustriaUniversity, hospital or other
- Collaborators
- University of Wisconsin, Milwaukee
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 13 Oct 2021 (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.
This clinical investigation is a monocenter, prospective, randomized, controlled, counter-balanced, two-arm study investigating the effect of a novel ergonomic handwriting pen.
Detailed description
Background:
Extended and prolonged handwriting activities can be exhausting for the writer and can lead to muscle cramps, irritations in the hand and lower arm as well as high pressures in the fingers and pain. As muscle pain in the upper extremities can affect hand writing quality, and as it is well known that high tendon activities and tissue pressures can lead to health issues, there is a need for ergonomic handwriting materials, especially for people with prolonged and extended handwriting activities (e.g. students).
Despite the high number of ergonomic handwriting pens on the market, clinical or scientific investigations for such pens are very rare. Indeed only a few studies on such pens are available, and there is little knowledge on how ergonomics can impact physiological and performance parameters. As high forces and pressures in the hand region over a long period of time can lead to health issues, a pen design targeting the reduction of grip forces and pressures was developed.
To investigate if this pen design can affect handwriting performance, perceived fatigue, pen and discomfort, the AWP pen study was developed. To follow international recommendations and to reduce potential bias as well as interpersonal variation, this study was designed as randomized controlled counter-balanced trial. The insights of this study can further help to develop novel handwriting tools and to support people with handwriting disabilities (e.g. stroke patients).
Methods:
The study consists of one assessment day / visit only. During this visit and after proving the study eligibility (inclusion / exclusion criteria), half of the study participants will randomly be allocated to one of two study groups. Depending on the group allocation participants will either execute the first assessment trial with an ergonomic (= intervention) or common (= control) handwriting pen. The randomization will be realized with opaque envelopes created by an external and independent person.
Overall participants will execute the identical assessment trial / test battery with the control and the intervention pen. Each assessment trial consists of writing speed and accuracy tasks, followed by the "Handwriting Assessment Battery for Adults" (HAB) and a fatigue task. These assessments are followed by Visual Analogue Scales and a questionnaire.
Due to the counter-balanced design and the fatigue tasks, the break between both assessment trials will take at least 20 minutes to ensure similar baseline conditions for both pens. The influence of incomplete fatigue recovery as well as practice effects will be reduced by the counter-balanced design.
The overall duration of study participation ranges between 2.5 and 4 hours.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention first arm | Experimental | Other: Ergonomic handwriting penDue to the counter-balanced design of this study all participants will experience both an interventional and a control period. Within the "intervention first arm" participants will be asked to execute the assessment trial / test battery with the intervention pen first. After a wash-out period, the participants will execute the same assessment trial / test battery with the control pen. |
| Control first arm | Experimental | Other: Ergonomic handwriting penDue to the counter-balanced design of this study all participants will experience both an interventional and a control period. Within the "control first arm" participants will be asked to execute the assessment trial / test battery with the control pen first. After a wash-out period, the participants will execute the same assessment trial / test battery with the intervention pen. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Informed consent
- People aged between 18 and 50 years
- People free of acute or chronical diseases limiting their handwriting capabilities (e.g. Parkinson, hand/arm amputee)
- Education level: at least high school diploma
- People using a handwriting pen > once per week
Key exclusion criteria (4 listed)
- People with mental disorders limiting their writing performance
- People with chronical fatigue syndrome
- People incapable of concentrating on tasks for more than 30 minutes
- Non-corrected visual disturbances
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 |
|---|---|---|
| Ergonomic handwriting penAn ergonomic handwriting pen called AWP-pen designed to reduce perceived muscle fatigue, finger tip pressure and discomfort during handwriting activities. | Other | Control first arm, Intervention first arm |
Primary outcome
Subjectively perceived muscle fatigue changes as determined with a Visual Analogue Scale (VAS)
Time frame: 1 experimental day
Subjects will rate their subjectively perceived muscle fatigue prior and after the test battery by means of a Visual Analogue Scale (VAS). The VAS used for this study ranges from 0 (none) to 100 (strongly pronounced) points. Question: How would you describe your current muscle fatigue in your writing hand?
Subjectively perceived discomfort as determined with a Visual Analogue Scale (VAS)
Time frame: 1 experimental day
Subjects will rate their subjectively perceived discomfort in the writing hand prior and after the test battery by means of a Visual Analogue Scale (VAS). The VAS used for this study ranges from 0 (none) to 100 (strongly pronounced) points. Question: How would you describe your current discomfort in the writing hand?
9 secondary outcomes
Muscle pain estimated as determined with a Visual Analogue Scale (VAS)
Time frame: 1 experimental day
Handwriting speed as determined with a maze task (accuracy based)
Time frame: 1 experimental day
Handwriting speed as determined with a maze task (speed and accuracy based)
Time frame: 1 experimental day
Handwriting speed as determined with a dot in cycle task
Time frame: 1 experimental day
Handwriting speed as determined with a fatigue task
Time frame: 1 experimental day
Positioning accuracy as determined with a maze task (accuracy based)
Time frame: 1 experimental day
Positioning accuracy as determined with a maze task (speed and accuracy based)
Time frame: 1 experimental day
Handwriting performance as determined with the Handwriting Assessment Battery for Adults (HAB)
Time frame: 1 experimental day
Usability as determined with a non-standardized questionaire
Time frame: 1 experimental day
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 23 Nov 2021.
- 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.
Bernhard Schwartz, Dr. MSc BSc principal investigator
University of Applied Sciences for Health Professions Upper Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergonomic handwriting pen in people with Muscle Fatigue, run by University of Applied Sciences for Health Professions Upper Austria at 1 site in Austria.
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 6 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 23 Nov 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 Austria. 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?
Subjectively perceived muscle fatigue changes as determined with a Visual Analogue Scale (VAS) (time frame: 1 experimental 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 23 Nov 2021.