Nerve InjuryNCT05302141
Effects of Assistive Device on ADL Function in Patients With Nerve Injury
A study testing Wear 3D printing assistive device and Wear universal cuff device in people with Nerve Injury, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
Our study is aimed to evaluate the effect of 3D printing assistive device on hand function for patients with neural injury. 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?
- Wear 3D printing assistive device and Wear universal cuff device
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Mar 2022to 20 Sep 2022
- Phase
- Interventional
- 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
Who may be able to join
- The medical record shows the diagnosis of central or peripheral nerve injury, and the onset is more than three months
- Able to understand wearing operation instructions and have the ability to give informed consent
- Able to control shoulder lifting and bending elbows, but difficult to grasp tools
Who cannot join
- Older than 75 years old and younger than 20 years old
- Severe visual or hearing impairment
- Suffering from other neurological, cardiopulmonary, or musculoskeletal diseases that affect the subject to perform the actions required by this test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 3D Printing Assistive Device on ADL Function in Patients With Nerve Injury
Our study is aimed to evaluate the effect of 3D printing assistive device on hand function for patients with neural injury.
Read the detailed description
Background: Injury to the central or peripheral nerves can lead to limited hand function and further affect the ability of daily life. The use of assistive devices can assist functional activities and reduce the phenomenon of non-use. 3D printing technology was used to construct personalized, complicated orthosis, and one piece to reduce assembly time. But the evidence most are product development, but few of study investigate the effectiveness and it cannot be widely used for hand injuries.
Aim: To evaluate the effect of 3D printing assistive device on hand function for patients with neural injury.
Methods: Thirty neural injury patients were recruited and randomized into experimental (3D printing assistive device) or control (universal cuff) groups for 4 weeks of treatment (thirty minutes a time, twice a week). The performance was assessed by a blinded assessor included Active Range of motion (AROM), Box and block test, Grip dynamometer, upper extremity task, Disability of the arm, shoulder and hand questionnaire(DASH), General Health Questionnaire(GHQ-12) and Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST). The practice performance and adverse effect were recorded. Collected data will be analyzed with nonparametric tests by SPSS version 20.0, and alpha level was set at .05.
Keywords: Neural injury, 3D printing, assistive device, hand function.
- Conditions
- Nerve Injury
- Being tested
- Wear 3D printing assistive device, Wear universal cuff device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wear 3D printing assistive deviceBehavioural
Wear 3D printing aids and engage in functional tasks, including eating, typing, and writing.
At home: use daily, 30 minutes each time; Treatment room: 30 minutes twice a week
Wear universal cuff deviceBehavioural
Wear universal cuff aids and engage in functional tasks, including eating, typing, and writing.
At home: use daily, 30 minutes each time; Treatment room: 30 minutes twice a week
| Study group | Role | What they receive |
|---|---|---|
| 3D printing assistive device group | Experimental | experimental (3D printing assistive device) groups for 4 weeks of treatment (thirty minutes a time, twice a week). Receives: Behavioral: Wear 3D printing assistive device |
| universal cuff groups | Active comparator | control (universal cuff) groups for 4 weeks of treatment (thirty minutes a time, twice a week). Receives: Behavioral: Wear universal cuff device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active joint range of motion of shoulder and elbow
use a goniometer to measure the active joint movements of the shoulder and elbow, including shoulder flexion, abduction, external rotation , internal rotation, and elbow flexion angle.
Measured: Change from Baseline at 2 weeks and 4 weeks
Secondary outcomes (7)
Box and block test (BBT)
Assess grasping, transporting, and releasing small blocks, and count the number of blocks the individual moves 1 inch to the opposite side of the box in one minute.
Measured: Change from Baseline at 2 weeks and 4 weeks
Grip power
use the Jamar Dynamometer (Asimow Engineering Co., CA, USA) grip strength device to test, ask the individual to bend the elbow and shoulder adduct, and hold the grip strength device firmly, and measure the average 3 times in total
Measured: Change from Baseline at 2 weeks and 4 weeks
Hand function tasks
Complete the tasks of writing, spoon, and typing. The writing task is based on the writing sub-item of the Basic Literacy Test, and the individual is asked to write a short sentence, the content is 25 words, count the number of words in two minute; spoon task, ask the client to use a spoon to scoop five kidney beans into a can, and count the seconds it takes; one-minute typing test (https://typing.tw/), to see the number of words typed in one minute with the correct rate.
Measured: Change from Baseline at 2 weeks and 4 weeks
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
The first and second subscales are used. To evaluate the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale., which are converted into 100 points. The higher the score, the higher the severity.
Measured: Change from Baseline at 4 weeks
General Health Questionnaire (GHQ-12)
Self-rating scale used to measure mental health status. Respondents rated the frequency of occurrence of each item in the past month on a scale of 0 (not at all) to 3 (often). The total score can be up to 36 points, and a score of 15 or more can be defined as mental distress. The higher the score, the more serious the distress.
Measured: Change from Baseline at 4 weeks
Daily wearing activity record sheet
To record the daily wearing and practice time, the number of side effects, such as soreness, pain, injury, etc.
Measured: Every training session during 8 sessions, total sessions continued to 4 weeks
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
The questionnaire is a subjective self-administered scale for the use of assistive devices, with a 5-point scale (strongly agree to strongly disagree), including beauty, complexity, weight , resistance, comfort, easy to wear, etc.
Measured: The end of the study at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start21 Mar 2022
- Primary completion20 Sep 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sponsor GmbH
- Responsible party
- Sponsor
- Investigators
- Hsinchieh Lee, master, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302141
- Sponsor's protocol ID
- N202201010
- Status last verified
- Feb 2022
- First submitted
- 20 Mar 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
Amaral DS, Duarte ALBP, Barros SS, Cavalcanti SV, Ranzolin A, Leite VMM, Dantas AT, Oliveira ASCRC, Santos PS, Silva JCA, Marques CDL. Assistive devices: an effective strategy in non-pharmacological treatment for hand osteoarthritis-randomized clinical trial. Rheumatol Int. 2018 Mar;38(3):343-351. doi: 10.1007/s00296-017-3892-1. Epub 2017 Nov 28.
PubMed 29185087Armour 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 27594781Basteris A, Nijenhuis SM, Stienen AH, Buurke JH, Prange GB, Amirabdollahian F. Training modalities in robot-mediated upper limb rehabilitation in stroke: a framework for classification based on a systematic review. J Neuroeng Rehabil. 2014 Jul 10;11:111. doi: 10.1186/1743-0003-11-111.
PubMed 25012864Bethoux 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 26522902Cazon, A., Aizpurua, J., Paterson, A., Bibb, R., Campbell, R. I. J. V., & Prototyping, P. (2014). Customised design and manufacture of protective face masks combining a practitioner-friendly modelling approach and low-cost devices for digitising and additive manufacturing: This paper analyses the viability of replacing conventional practice with AM method to make customized protective face masks. 9(4), 251-261.
Chae DS, Kim DH, Kang KY, Kim DY, Park SW, Park SJ, Kim JH. The functional effect of 3D-printing individualized orthosis for patients with peripheral nerve injuries: Three case reports. Medicine (Baltimore). 2020 Apr;99(16):e19791. doi: 10.1097/MD.0000000000019791.
PubMed 32311991Chen HM, Chen CC, Hsueh IP, Huang SL, Hsieh CL. Test-retest reproducibility and smallest real difference of 5 hand function tests in patients with stroke. Neurorehabil Neural Repair. 2009 Jun;23(5):435-40. doi: 10.1177/1545968308331146. Epub 2009 Mar 4.
PubMed 19261767Sanchez-Lopez Mdel P, Dresch V. The 12-Item General Health Questionnaire (GHQ-12): reliability, external validity and factor structure in the Spanish population. Psicothema. 2008 Nov;20(4):839-43.
PubMed 18940092Diment LE, Thompson MS, Bergmann JH. Three-dimensional printed upper-limb prostheses lack randomised controlled trials: A systematic review. Prosthet Orthot Int. 2018 Feb;42(1):7-13. doi: 10.1177/0309364617704803. Epub 2017 Jun 24.
PubMed 28649911Fitzpatrick, A. P., Mohanned, M. I., Collins, P. K., & Gibson, I. (2017). Design of a patient specific, 3D printed arm cast. KnE Engineering, 135-142.
Funch A, Kruse NB, la Cour K, Peoples H, Waehrens EE, Brandt A. The association between having assistive devices and activities of daily living ability and health-related quality of life: An exploratory cross-sectional study among people with advanced cancer. Eur J Cancer Care (Engl). 2019 May;28(3):e13002. doi: 10.1111/ecc.13002. Epub 2019 Feb 10.
PubMed 30740805Gerhardt JJ, Rondinelli RD. Goniometric techniques for range-of-motion assessment. Phys Med Rehabil Clin N Am. 2001 Aug;12(3):507-27.
PubMed 11478185Hamilton GF, McDonald C, Chenier TC. Measurement of grip strength: validity and reliability of the sphygmomanometer and jamar grip dynamometer. J Orthop Sports Phys Ther. 1992;16(5):215-9. doi: 10.2519/jospt.1992.16.5.215.
PubMed 18796752Harman, D., & Craigie, S. J. E. G. M. (2011). Gerotechnology series: Toileting aids. 2(5), 314-318.
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
- Effects of 3D Printing Assistive Device on ADL Function in Patients With Nerve Injury
- ClinicalTrials.gov ID
- NCT05302141
- Acronym / sponsor ID
- N202201010
- Conditions
- Nerve Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Collaborators
- Sponsor GmbH
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 31 Mar 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.
Our study is aimed to evaluate the effect of 3D printing assistive device on hand function for patients with neural injury.
Detailed description
Background: Injury to the central or peripheral nerves can lead to limited hand function and further affect the ability of daily life. The use of assistive devices can assist functional activities and reduce the phenomenon of non-use. 3D printing technology was used to construct personalized, complicated orthosis, and one piece to reduce assembly time. But the evidence most are product development, but few of study investigate the effectiveness and it cannot be widely used for hand injuries.
Aim: To evaluate the effect of 3D printing assistive device on hand function for patients with neural injury.
Methods: Thirty neural injury patients were recruited and randomized into experimental (3D printing assistive device) or control (universal cuff) groups for 4 weeks of treatment (thirty minutes a time, twice a week). The performance was assessed by a blinded assessor included Active Range of motion (AROM), Box and block test, Grip dynamometer, upper extremity task, Disability of the arm, shoulder and hand questionnaire(DASH), General Health Questionnaire(GHQ-12) and Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST). The practice performance and adverse effect were recorded. Collected data will be analyzed with nonparametric tests by SPSS version 20.0, and alpha level was set at .05.
Keywords: Neural injury, 3D printing, assistive device, hand function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D printing assistive device group | Experimental | Behavioral: Wear 3D printing assistive deviceexperimental (3D printing assistive device) groups for 4 weeks of treatment (thirty minutes a time, twice a week). |
| universal cuff groups | Active comparator | Behavioral: Wear universal cuff devicecontrol (universal cuff) groups for 4 weeks of treatment (thirty minutes a time, twice a week). |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The medical record shows the diagnosis of central or peripheral nerve injury, and the onset is more than three months
- Able to understand wearing operation instructions and have the ability to give informed consent
- Able to control shoulder lifting and bending elbows, but difficult to grasp tools
Key exclusion criteria (3 listed)
- Older than 75 years old and younger than 20 years old
- Severe visual or hearing impairment
- Suffering from other neurological, cardiopulmonary, or musculoskeletal diseases that affect the subject to perform the actions 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 |
|---|---|---|
| Wear 3D printing assistive deviceWear 3D printing aids and engage in functional tasks, including eating, typing, and writing. At home: use daily, 30 minutes each time; Treatment room: 30 minutes twice a week | Behavioural | 3D printing assistive device group |
| Wear universal cuff deviceWear universal cuff aids and engage in functional tasks, including eating, typing, and writing. At home: use daily, 30 minutes each time; Treatment room: 30 minutes twice a week | Behavioural | universal cuff groups |
Primary outcome
Active joint range of motion of shoulder and elbow
Time frame: Change from Baseline at 2 weeks and 4 weeks
use a goniometer to measure the active joint movements of the shoulder and elbow, including shoulder flexion, abduction, external rotation , internal rotation, and elbow flexion angle.
7 secondary outcomes
Box and block test (BBT)
Time frame: Change from Baseline at 2 weeks and 4 weeks
Grip power
Time frame: Change from Baseline at 2 weeks and 4 weeks
Hand function tasks
Time frame: Change from Baseline at 2 weeks and 4 weeks
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Time frame: Change from Baseline at 4 weeks
General Health Questionnaire (GHQ-12)
Time frame: Change from Baseline at 4 weeks
Daily wearing activity record sheet
Time frame: Every training session during 8 sessions, total sessions continued to 4 weeks
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
Time frame: The end of the study at 4 weeks
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 29185087Amaral DS, Duarte ALBP, Barros SS, Cavalcanti SV, Ranzolin A, Leite VMM, Dantas AT, Oliveira ASCRC, Santos PS, Silva JCA, Marques CDL. Assistive devices: an effective strategy in non-pharmacological treatment for hand osteoarthritis-randomized clinical trial. Rheumatol Int. 2018 Mar;38(3):343-351. doi: 10.1007/s00296-017-3892-1. Epub 2017 Nov 28.
- 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 25012864Basteris A, Nijenhuis SM, Stienen AH, Buurke JH, Prange GB, Amirabdollahian F. Training modalities in robot-mediated upper limb rehabilitation in stroke: a framework for classification based on a systematic review. J Neuroeng Rehabil. 2014 Jul 10;11:111. doi: 10.1186/1743-0003-11-111.
- 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.
- BackgroundCazon, A., Aizpurua, J., Paterson, A., Bibb, R., Campbell, R. I. J. V., & Prototyping, P. (2014). Customised design and manufacture of protective face masks combining a practitioner-friendly modelling approach and low-cost devices for digitising and additive manufacturing: This paper analyses the viability of replacing conventional practice with AM method to make customized protective face masks. 9(4), 251-261.
- Background: PubMed 32311991Chae DS, Kim DH, Kang KY, Kim DY, Park SW, Park SJ, Kim JH. The functional effect of 3D-printing individualized orthosis for patients with peripheral nerve injuries: Three case reports. Medicine (Baltimore). 2020 Apr;99(16):e19791. doi: 10.1097/MD.0000000000019791.
- Background: PubMed 19261767Chen HM, Chen CC, Hsueh IP, Huang SL, Hsieh CL. Test-retest reproducibility and smallest real difference of 5 hand function tests in patients with stroke. Neurorehabil Neural Repair. 2009 Jun;23(5):435-40. doi: 10.1177/1545968308331146. Epub 2009 Mar 4.
- Background: PubMed 18940092Sanchez-Lopez Mdel P, Dresch V. The 12-Item General Health Questionnaire (GHQ-12): reliability, external validity and factor structure in the Spanish population. Psicothema. 2008 Nov;20(4):839-43.
- Background: PubMed 28649911Diment LE, Thompson MS, Bergmann JH. Three-dimensional printed upper-limb prostheses lack randomised controlled trials: A systematic review. Prosthet Orthot Int. 2018 Feb;42(1):7-13. doi: 10.1177/0309364617704803. Epub 2017 Jun 24.
- BackgroundFitzpatrick, A. P., Mohanned, M. I., Collins, P. K., & Gibson, I. (2017). Design of a patient specific, 3D printed arm cast. KnE Engineering, 135-142.
- Background: PubMed 30740805Funch A, Kruse NB, la Cour K, Peoples H, Waehrens EE, Brandt A. The association between having assistive devices and activities of daily living ability and health-related quality of life: An exploratory cross-sectional study among people with advanced cancer. Eur J Cancer Care (Engl). 2019 May;28(3):e13002. doi: 10.1111/ecc.13002. Epub 2019 Feb 10.
- 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?
A study testing Wear 3D printing assistive device and Wear universal cuff device in people with 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 3 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?
Active joint range of motion of shoulder and elbow (time frame: Change from Baseline at 2 weeks and 4 weeks). 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 NCT05302141, which also lists 43 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.