Muscle Fatigue Clinical Trial
Official title:
Efficacy of an Ergonomic Handwriting Pen - a Monocenter Randomized Controlled Counter-balanced Trial
Verified date | November 2021 |
Source | University of Applied Sciences for Health Professions Upper Austria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical investigation is a monocenter, prospective, randomized, controlled, counter-balanced, two-arm study investigating the effect of a novel ergonomic handwriting pen.
Status | Completed |
Enrollment | 17 |
Est. completion date | October 8, 2021 |
Est. primary completion date | October 8, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Austria | University of Applied Sciences for Health Professions Upper Austria | Linz | Upper Austria |
Lead Sponsor | Collaborator |
---|---|
University of Applied Sciences for Health Professions Upper Austria | University of Wisconsin, Milwaukee |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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? |
1 experimental day | |
Primary | 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? |
1 experimental day | |
Secondary | 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? |
1 experimental day | |
Secondary | 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. |
1 experimental day | |
Secondary | 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. |
1 experimental day | |
Secondary | 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. |
1 experimental day | |
Secondary | 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. | 1 experimental day | |
Secondary | 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. |
1 experimental day | |
Secondary | 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. |
1 experimental day | |
Secondary | 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. |
1 experimental day | |
Secondary | 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. | 1 experimental day |
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