Clinical trial NCT05077046: Efficacy of an Ergonomic Handwriting Pen - The AWP Pen Study
Official title: Efficacy of an Ergonomic Handwriting Pen - a Monocenter Randomized Controlled Counter-balanced Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Fatigue
Keywords: Office Work
Handwriting Performance
Pain
Discomfort
Lead sponsor: University of Applied Sciences for Health Professions Upper Austria
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Milwaukee
First posted: 2021-10-13
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjectively perceived muscle fatigue changes as determined with a Visual Analogue Scale (VAS)
timeFrame: 1 experimental day
measure: Subjectively perceived discomfort as determined with a Visual Analogue Scale (VAS)
timeFrame: 1 experimental day
Secondary outcomes:
measure: Muscle pain estimated as determined with a Visual Analogue Scale (VAS)
timeFrame: 1 experimental day
measure: Handwriting speed as determined with a maze task (accuracy based)
timeFrame: 1 experimental day
measure: Handwriting speed as determined with a maze task (speed and accuracy based)
timeFrame: 1 experimental day
measure: Handwriting speed as determined with a dot in cycle task
timeFrame: 1 experimental day
measure: Handwriting speed as determined with a fatigue task
timeFrame: 1 experimental day
measure: Positioning accuracy as determined with a maze task (accuracy based)
timeFrame: 1 experimental day
measure: Positioning accuracy as determined with a maze task (speed and accuracy based)
timeFrame: 1 experimental day
measure: Handwriting performance as determined with the Handwriting Assessment Battery for Adults (HAB)
timeFrame: 1 experimental day
measure: Usability as determined with a non-standardized questionaire
timeFrame: 1 experimental day
Other outcomes:
Locations:
city: Linz
country: Austria
facility: University of Applied Sciences for Health Professions Upper Austria
state: Upper Austria
Study officials:
affiliation: University of Applied Sciences for Health Professions Upper Austria
name: Bernhard Schwartz, Dr. MSc BSc
role: PRINCIPAL_INVESTIGATOR
References: