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

NCT05589324 | Completed

• 1 other identifier: TMU-JIRB N202206087
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Nerve Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

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

Interventions

3D-printed writing aids task BEHAVIORAL

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.

3D-printed writing aids group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In cases of central or peripheral nerve injury, symptoms such as sensory paralysis, limited joint mobility, insufficient muscle strength, abnormal tension, unsmooth movements, and lack of segmental movement control may result, affecting the voluntary control of muscles, and showing weak and inaccurate movements. , slowing down, affecting their hand performance, which in turn affects writing tasks

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

Location

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  BACKGROUND

Study Officials

• Hsinchieh Lee, Master

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: October 21, 2022
• Study Start: November 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)