Efficacy of an Ergonomic Handwriting Pen - The AWP Pen Study
Condition: Muscle Fatigue
MeSH terms: Fatigue
Study type: Interventional

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.
    

Intervention name(s): Ergonomic handwriting pen
Intervention type(s): Other
Intervention description(s): An ergonomic handwriting pen called AWP-pen designed to reduce perceived muscle fatigue, finger tip pressure and discomfort during handwriting activities.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Office Work; Handwriting Performance; Pain; Discomfort