Efficacy of an Ergonomic Handwriting Pen - The AWP Pen Study

NCT ID: NCT05077046

Last Updated: 2021-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-27
• Study Completion Date: 2021-10-08

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.

Conditions

Muscle Fatigue

Keywords

Office Work; Handwriting Performance; Pain; Discomfort

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention first arm

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.

Group Type: EXPERIMENTAL

Ergonomic handwriting pen

Intervention Type: OTHER

An ergonomic handwriting pen called AWP-pen designed to reduce perceived muscle fatigue, finger tip pressure and discomfort during handwriting activities.

Control first arm

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.

Group Type: EXPERIMENTAL

Ergonomic handwriting pen

Intervention Type: OTHER

An ergonomic handwriting pen called AWP-pen designed to reduce perceived muscle fatigue, finger tip pressure and discomfort during handwriting activities.

Interventions

Ergonomic handwriting pen

An ergonomic handwriting pen called AWP-pen designed to reduce perceived muscle fatigue, finger tip pressure and discomfort during handwriting activities.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Milwaukee

OTHER

Sponsor Role: collaborator

University of Applied Sciences for Health Professions Upper Austria

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernhard Schwartz, Dr. MSc BSc

Role: PRINCIPAL_INVESTIGATOR

University of Applied Sciences for Health Professions Upper Austria

Locations

University of Applied Sciences for Health Professions Upper Austria

Linz, Upper Austria, Austria

Countries

Austria

Other Identifiers

AWP-Pen 001

Identifier Type: -

Identifier Source: org_study_id