Nerve InjuryNCT05589324
Effects of 3D Printing Writing Assisitive Device on Feasibility in Patients With Nerve Injury
An observational study of Nerve Injury, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Nerve Injury
- What is being tested?
- 3D-printed writing aids task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Different Angle of 3D Printing Writing Assisitive Device on Feasibility in Patients With Nerve Injury
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.
Read the 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.
- Conditions
- Nerve Injury
- Being tested
- 3D-printed writing aids task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printed writing aids taskBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: 3D-printed writing aids task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: From date of writing task until 4 situations complete, assessed up to 1 session. Each session lasting 60 minutes within one day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Nov 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Nerve InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsinchieh Lee, Taipei Medical University Shuang Ho Hospital
- Investigators
- Hsinchieh Lee, Master, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589324
- Sponsor's protocol ID
- TMU-JIRB N202206087
- Status last verified
- Apr 2023
- First submitted
- 27 Jul 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27552260Baronio 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.
PubMed 27594781Bethoux 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.
PubMed 26522902Chang 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.
PubMed 26141665De 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.
PubMed 32423845Jumani, 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.
PubMed 23934582Kushki 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.
PubMed 21315553Lee 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.
PubMed 30318956Long 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.
PubMed 17569392Lubbes, 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.
PubMed 19906764Marque 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.
PubMed 25282582
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Different Angle of 3D Printing Writing Assisitive Device on Feasibility in Patients With Nerve Injury
- ClinicalTrials.gov ID
- NCT05589324
- Acronym / sponsor ID
- TMU-JIRB N202206087
- Conditions
- Nerve Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D-printed writing aids group | – | Behavioral: 3D-printed writing aids taskThirty 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-printed writing aids taskBriefly 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. | Behavioural | 3D-printed writing aids group |
Primary outcome
Writing task
Time frame: 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).
1 secondary outcome
Assistive device satisfaction scale
Time frame: From date of writing task until 4 situations complete, assessed up to 1 session. Each session lasting 60 minutes within one day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Background: PubMed 27552260Armour 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.
- Background: PubMed 27594781Baronio 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.
- Background: PubMed 26522902Bethoux 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.
- Background: PubMed 26141665Chang 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.
- BackgroundDe 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.
- BackgroundHunzeker, 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.
- Background: PubMed 32423845Janson 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.
- BackgroundJumani, M., Shaikh, S., & Shah, S. A. J. S. I. (2014). RAPID MANUFACTURING TECHNIQUE FOR FABRICATION OF CUSTOM-MADE FOOT ORTHOSES. 26(1).
- Background: PubMed 23934582Kuo 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.
- Background: PubMed 21315553Kushki 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.
- Background: PubMed 30318956Lee 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.
- Background: PubMed 17569392Long 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsinchieh Lee, Master principal investigator
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nerve Injury, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Writing task (time frame: From date of writing task until 4 situations complete, assessed up to 1 session. Each session lasting 60 minutes within one day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05589324, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.