Efficacy of an Ergonomic Handwriting Pen - The AWP Pen Study

NCT05077046 | Completed DMC

• 1 other identifier: AWP-Pen 001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Fatigue

Keywords

Office Work; Handwriting Performance; Pain; Discomfort

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• Muscle pain estimated as determined with a Visual Analogue Scale (VAS)

  1 experimental day

• Handwriting speed as determined with a maze task (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 dot in cycle task

  1 experimental day

• Handwriting speed as determined with a fatigue task

  1 experimental day

Study Arms (2)

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.

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.

Other: Ergonomic handwriting pen

Interventions

Ergonomic handwriting pen 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; Intervention first arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Applied Sciences for Health Professions Upper Austria: lead
• University of Wisconsin, Milwaukee: collaborator

Study Sites (1)

University of Applied Sciences for Health Professions Upper Austria

Linz, Upper Austria, 4020, Austria

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernhard Schwartz, Dr. MSc BSc

  University of Applied Sciences for Health Professions Upper Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: October 13, 2021
• Study Start: September 27, 2021
• Primary Completion: October 8, 2021
• Study Completion: October 8, 2021
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)