Effects of 3D Printing Writing Assisitive Device on Feasibility in Patients With Nerve Injury

Nerve Injury Clinical Trial

Official title:

The Effectiveness of Different Angle of 3D Printing Writing Assisitive Device on Feasibility in Patients With Nerve Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05589324
• Other study ID #: TMU-JIRB N202206087
• Status: Completed
• Start date: November 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Injury to the central or peripheral nerves can lead to limited hand function and further affect the ability of writing. The use of assistive devices can assist writing performance. However, the habit of holding the pen and the ability of the individual case will affect the selection of aids and the efficiency of writing. The 3D printing aids can be individually designed and adjusted to different angles and types. There is no criterion for 3D printing aids decision, often using a case-by-case trial subjective way to confirm, matching takes more time. Aim: To compare the applicability and efficiency of different types of 3D-printed writing aids in nerve injury cases, and to explore which factors affect the choice of aids.

Description:

Background: Injury to the central or peripheral nerves can lead to limited hand function and further affect the ability of writing. The use of assistive devices can assist writing performance. However, the habit of holding the pen and the ability of the individual case will affect the selection of aids and the efficiency of writing. The 3D printing aids can be individually designed and adjusted to different angles and types. There is no criterion for 3D printing aids decision, often using a case-by-case trial subjective way to confirm, matching takes more time. Aim: To compare the applicability and efficiency of different types of 3D-printed writing aids in nerve injury cases, and to explore which factors affect the choice of aids.

Methods: Thirty subjects were recruited from outpatient rehabilitation of neurologically injured patients with limited hand function. Their basic information was recorded, including basic abilities, palm and finger size, and pen-holding posture, etc. Using three different angles of 3D printing writing aids, the writing efficiency and the satisfaction of the aids are evaluated by the writing task and the Satisfaction with Assistive Technology. Collected data were analyzed by SPSS (Version 20.0). The significance level of the statistical value is set at 0.05. The basic data and evaluation items of the subjects are observed by descriptive statistical analysis. All the analyzed values will be presented in the form of mean ± standard deviation. The Wilcoxon test is used to compare before and after the use of assistive devices. Data between different aids were analyzed by one-way analysis of variance (ANOVA) with Bonferroni adjustment; basic data and aids choice were analyzed by Pearson's Chi-Square correlation analysis; liner regression was used, and Backward regression was used to confirm whether the variable was removed (p>0.1), and univariate analyses in a general linear manner were used to analyze whether the independent variables of the basic data affected the choice of assistive devices.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• The medical record shows that the diagnosis is central or peripheral nerve injury, and the onset is more than three months

• The trunk is well controlled and can sit stable on the chair

• The affected hand can control the lifting of the shoulder and the bending of the elbow, and the forearm can be controlled.

• The affected hand is the dominant hand and has difficulty writing

Exclusion Criteria:

• Aged over 75 and under 20

• Cognition or visual perception impairment that affects their ability to copy

• Patients suffer from other diseases of the nervous, cardiopulmonary, and musculoskeletal systems that affect the subject's performance of the movements required by this test.

Related Conditions & MeSH terms

• Nerve Injury
• Wounds and Injuries

Intervention

Behavioral:
• 3D-printed writing aids task
Briefly explain how to wear assistive devices, confirm that the case understands how to operate, and conduct a writing task test. Situation includes no wearable assistive device,three pen placement designs with different angles (5 degrees, 20 degrees, and 30 degrees). Record the writing speed, legibility, posture, and satisfaction of the assistive device after each writing task, etc.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Shuang Ho Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (20)

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Writing task	The individual is asked to copy short sentences in four situations including no wearing aids, writing aids with three angles (5 degrees, 20 degrees, 30 degrees). Calculate the time and quality it takes to complete 10 words. To record its speed, quality (the legibility of the correct number of words, the size of the writing, the number of times it exceeds the line, whether the strength is sufficient and consistent).	From date of writing task until 4 situations complete, assessed up to 1 session. Each session lasting 60 minutes within one day.
Secondary	Assistive device satisfaction scale	The questionnaire is a subjective self-filling scale for the use of assistive devices, and the visual analog scale 0-10 scale is used. The items include the writing speed, ease of use, comfort, effectiveness, etc.	From date of writing task until 4 situations complete, assessed up to 1 session. Each session lasting 60 minutes within one day.