Clinical Trials Logo

Clinical Trial Summary

This clinical investigation is a monocenter, prospective, randomized, controlled, counter-balanced, two-arm study investigating the effect of a novel ergonomic handwriting pen.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05077046
Study type Interventional
Source University of Applied Sciences for Health Professions Upper Austria
Contact
Status Completed
Phase N/A
Start date September 27, 2021
Completion date October 8, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05073224 - Muscle Function After Childbirth N/A
Completed NCT03576391 - The Influence of Fatigue on Trunk Motor Control and Brain Activity N/A
Recruiting NCT05528250 - The Effect of Quadriceps Muscle Fatigue on Balance
Completed NCT02923102 - Effects of Recoverben® on Recovery After Exhaustive Exercise N/A
Completed NCT01962298 - Recovery of Diaphragmatic Function After Neuromuscular Blockade and Sugammadex Phase 3
Recruiting NCT03460639 - Administration of Low-level Laser on Muscles of Mastication Following the Induction of Initial Fatigue N/A
Enrolling by invitation NCT04367727 - Effect of Light Emitting Diode Therapy on Muscle Fatigue N/A
Completed NCT05862987 - The Effect of Hydrogen Rich Water Intake on Acute Body Response and Following Recovery After 5 km Run in Untrained Men N/A
Completed NCT01932281 - SierraSil Joint Formula 14 as an Ergogenic Aid to Performance in Athletes N/A
Recruiting NCT01764620 - Effects of Muscle Fatigue and a Taping Technique on Shoulder Motion of Athletes N/A
Recruiting NCT06406764 - Effects of a Plyometric Training Program on Youths With Different Biological Maturity in Sport N/A
Completed NCT03186573 - Effect of Grape Juice Consumption on the Parameters of Oxidative Stress and Muscle Fatigue in Judo Athletes N/A
Recruiting NCT03998280 - The Effect Of Cervical Muscle Fatigue in Neck Proprioception and Postural Stability
Not yet recruiting NCT02691806 - New Indices for Prediction of Human Fatigue During Training Based on Non-invasive Methods N/A
Completed NCT03863340 - Short Interventions to Prevent Trapezius Muscle Fatigue in Computer Work N/A
Completed NCT02014233 - Short Term Omega-3 Supplementation on Performance N/A
Not yet recruiting NCT06436781 - Effect of Maolactin™ FMR on Exercise Recovery, Inflammation, and Muscle Comfort in an Otherwise Healthy Population Phase 3
Completed NCT03712592 - Physiological Constraints Associated With Trail Running N/A
Recruiting NCT04082156 - The Effect of Transcutaneous Electrical Nerve Stimulation on People With Muscle Fatigue Due to Training, Sports N/A
Completed NCT04415099 - Tibialis Posterior Fatigue and Plantar Pressure N/A