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

Sponsor

Taipei Medical University Shuang Ho Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05589324

Collaborator

(none)

Enrollment

Location

3.9

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nerve Injury	Behavioral: 3D-printed writing aids task

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
3D-printed writing aids group Thirty subjects were recruited from outpatient rehabilitation of neurologically injured patients with limited hand function. Their basic information was recorded, including basic abilities 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.	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.

Arm

Intervention/Treatment

3D-printed writing aids group

Thirty subjects were recruited from outpatient rehabilitation of neurologically injured patients with limited hand function. Their basic information was recorded, including basic abilities 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.

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.

Outcome Measures

Primary Outcome Measures

Writing task [From date of writing task until 4 situations complete, assessed up to 1 session. Each session lasting 60 minutes within one day.]
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).

Secondary Outcome Measures

Assistive device satisfaction scale [From date of writing task until 4 situations complete, assessed up to 1 session. Each session lasting 60 minutes within one day.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Medical University Shuang Ho Hospital	New Taipei City		Taiwan

Sponsors and Collaborators

Taipei Medical University Shuang Ho Hospital

Investigators

Principal Investigator: Hsinchieh Lee, Master, Taipei Medical University Shuang Ho Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Hsinchieh Lee, Principal Investigator, Taipei Medical University Shuang Ho Hospital

ClinicalTrials.gov Identifier:

NCT05589324

Other Study ID Numbers:

TMU-JIRB N202206087

First Posted:

Oct 21, 2022

Last Update Posted:

Oct 21, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Wounds and Injuries

Study Results

No Results Posted as of Oct 21, 2022