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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05589324
Other study ID # TMU-JIRB N202206087
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)

Armour BS, Courtney-Long EA, Fox MH, Fredine H, Cahill A. Prevalence and Causes of Paralysis-United States, 2013. Am J Public Health. 2016 Oct;106(10):1855-7. doi: 10.2105/AJPH.2016.303270. Epub 2016 Aug 23. — View Citation

Baronio G, Harran S, Signoroni A. A Critical Analysis of a Hand Orthosis Reverse Engineering and 3D Printing Process. Appl Bionics Biomech. 2016;2016:8347478. doi: 10.1155/2016/8347478. Epub 2016 Aug 9. — View Citation

Bethoux F. Spasticity Management After Stroke. Phys Med Rehabil Clin N Am. 2015 Nov;26(4):625-39. doi: 10.1016/j.pmr.2015.07.003. Epub 2015 Sep 26. — View Citation

Chang SH, Chen CL, Yu NY. Biomechanical analyses of prolonged handwriting in subjects with and without perceived discomfort. Hum Mov Sci. 2015 Oct;43:1-8. doi: 10.1016/j.humov.2015.06.008. Epub 2015 Jun 30. — View Citation

De Stefano, C., Fontanella, F., Impedovo, D., Pirlo, G., & di Freca, A. S. J. P. R. L. (2019). Handwriting analysis to support neurodegenerative diseases diagnosis: A review. 121, 37-45.

Hunzeker, M., & Ozelie, R. (2021). A Cost-Effective Analysis of 3D Printing Applications in Occupational Therapy Practice. The Open Journal of Occupational Therapy, 9(1), 1-12.

Janson R, Burkhart K, Firchau C, Hicks K, Pittman M, Yopps M, Hatfield S, Garabrant A. Three-dimensional printed assistive devices for addressing occupational performance issues of the hand: A case report. J Hand Ther. 2020 Apr-Jun;33(2):164-169. doi: 10.1016/j.jht.2020.03.025. Epub 2020 May 16. — View Citation

Jumani, M., Shaikh, S., & Shah, S. A. J. S. I. (2014). RAPID MANUFACTURING TECHNIQUE FOR FABRICATION OF CUSTOM-MADE FOOT ORTHOSES. 26(1).

Kuo LC, Hsu HM, Wu PT, Lin SC, Hsu HY, Jou IM. Impact of distal median neuropathy on handwriting performance for patients with carpal tunnel syndrome in office and administrative support occupations. J Occup Rehabil. 2014 Jun;24(2):332-43. doi: 10.1007/s10926-013-9471-8. — View Citation

Kushki A, Schwellnus H, Ilyas F, Chau T. Changes in kinetics and kinematics of handwriting during a prolonged writing task in children with and without dysgraphia. Res Dev Disabil. 2011 May-Jun;32(3):1058-64. doi: 10.1016/j.ridd.2011.01.026. — View Citation

Lee KH, Kim DK, Cha YH, Kwon JY, Kim DH, Kim SJ. Personalized assistive device manufactured by 3D modelling and printing techniques. Disabil Rehabil Assist Technol. 2019 Jul;14(5):526-531. doi: 10.1080/17483107.2018.1494217. Epub 2018 Oct 14. — View Citation

Long TM, Woolverton M, Perry DF, Thomas MJ. Training needs of pediatric occupational therapists in assistive technology. Am J Occup Ther. 2007 May-Jun;61(3):345-54. doi: 10.5014/ajot.61.3.345. — View Citation

Lubbes, E. (2016). Investigation and Assessment of Upper-Limb Prosthetic Care and Business Model Design for 3D-Printed Prostheses in the Netherlands.

Ma HI, Hwang WJ, Tsai PL, Hsu YW. The effect of eating utensil weight on functional arm movement in people with Parkinson's disease: a controlled clinical trial. Clin Rehabil. 2009 Dec;23(12):1086-92. doi: 10.1177/0269215509342334. — View Citation

Marque P, Gasq D, Castel-Lacanal E, De Boissezon X, Loubinoux I. Post-stroke hemiplegia rehabilitation: evolution of the concepts. Ann Phys Rehabil Med. 2014 Nov;57(8):520-529. doi: 10.1016/j.rehab.2014.08.004. Epub 2014 Aug 23. — View Citation

Martin, L. M. J. A. J. o. O. T. (1988). Clinical Mechanics of the Hand. 42(3), 199-199.

McDonald SS, Levine D, Richards J, Aguilar L. Effectiveness of adaptive silverware on range of motion of the hand. PeerJ. 2016 Feb 15;4:e1667. doi: 10.7717/peerj.1667. eCollection 2016. — View Citation

Meulenbroek, R. G., & Thomassen, A. J. J. P. R. (1992). Effects of handedness and arm position on stroke-direction preferences in drawing. 54(3), 194-201.

Skymne C, Dahlin-Ivanoff S, Claesson L, Eklund K. Getting used to assistive devices: ambivalent experiences by frail elderly persons. Scand J Occup Ther. 2012 Mar;19(2):194-203. doi: 10.3109/11038128.2011.569757. Epub 2011 May 2. — View Citation

Will, E. J. HANDWRITING, BIOMECHANICS AND SIGNIFICANCE: CONCEPTS IN HANDWRITING IDENTIFICATION.

* Note: There are 20 references in allClick 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.
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