Efficacy of an Ergonomic Handwriting Pen - a Monocenter Randomized Controlled Counter-balanced Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Subjectively perceived muscle fatigue changes as determined with a Visual Analogue Scale (VAS)
Study Overview
Brief Summary
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Participant)
Masking Description
Participants will be informed that the effect of the handwriting pen design on different physiological parameters will be investigated within the study. Although participants know that they will execute the test battery twice with two different handwriting pens, they will receive no information on which of the pens will be the intervention of interest (intervention pen). To realize an efficient masking process, control pens will be exclusively created for the study. Control pens will be made of the same material and will contain cartridge. They will only differ in design.
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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?
Secondary Outcomes
- Handwriting speed as determined with a maze task (accuracy based)(1 experimental day)
- Muscle pain estimated as determined with a Visual Analogue Scale (VAS)(1 experimental day)
- Handwriting speed as determined with a dot in cycle task(1 experimental day)
- Positioning accuracy as determined with a maze task (accuracy based)(1 experimental day)
- Positioning accuracy as determined with a maze task (speed and accuracy based)(1 experimental day)
- Handwriting speed as determined with a maze task (speed and accuracy based)(1 experimental day)
- Handwriting speed as determined with a fatigue task(1 experimental day)
- Handwriting performance as determined with the Handwriting Assessment Battery for Adults (HAB)(1 experimental day)
- Usability as determined with a non-standardized questionaire(1 experimental day)