Disability PhysicalNCT05519891
3D Printed Assistive Devices for Individuals With Physical Disabilities
An observational study of Disability Physical, run by Moravian University at 1 site in United States.
Trial summary
Our research aims to examine 3D printed device satisfaction when using mobile devices for individuals with physical disabilities in long-term care facilities, and the impact of the 3D printed device integration on overall occupational performance and satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disability Physical
- What is being tested?
- Custom 3D printed device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals who are long-term residents of a Good Shepherd residential home, which provides 24 hour services for individuals with life-long physical disabilities, such as Cerebral Palsy, Muscular Dystrophy, Multiple Sclerosis, etc.
Who may be able to join
- Being over the age of 18
- Self-identified accessibility needs of the mobile device to address secondary to a physical accessibility limitation(s)
- Accessibility requests of a device that has not already been addressed by 3D printing
- Ownership or borrowing of a mobile device for personal use Operational definition of mobile devices: Mobile devices are a maximum length and width of 9.4" by 6.8" and must weigh less than 1.03 lb (e.g. dimensions of a standard iPad mini) and should be a one-handed use device with touch-screen capabilities
Who cannot join
- Individuals with severe cognitive impairment (BIMS score of 7 or less)
- Individuals who were unwilling to use a 3D printed device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Satisfaction of 3D Printed Assistive Devices for Individuals With Physical Disabilities Living in a Long-Term Care Setting
Our research aims to examine 3D printed device satisfaction when using mobile devices for individuals with physical disabilities in long-term care facilities, and the impact of the 3D printed device integration on overall occupational performance and satisfaction.
Read the detailed description
This feasibility study will be conducted at Good Shepherd Rehabilitation Network (GSRN) in the collection of data examining 3D printing outcomes. The 3D printed devices are within the current normal and customary care of GSRN services, with the focus on the created 3D printed adaptations for mobile device usage (i.e. smartphone adaptations). The feasibility data will assist in understanding the satisfaction and performance of 3D printed devices for persons with a physical disability.
- Conditions
- Disability Physical
- Being tested
- Custom 3D printed device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom 3D printed deviceOther
A 3D printed adaptation for a mobile device.
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure (COPM)
As a self-reported measure of occupational performance and occupational satisfaction, the scale ranges from 1-10, with 10 indicating a more favorable outcome in self-rated occupational performance and satisfaction.
Measured: 3-4 weeks
Secondary outcomes (1)
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
Participants will self-report satisfaction with the created and printed device and service on a Likert scale from 1-5, with 5 indicating maximum satisfaction.
Measured: 3-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start31 Aug 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 (3)Papers the sponsor has linked to this study.
- Other trials for Disability PhysicalStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moravian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Benham, OTD, Principal investigator, Moravian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519891
- Sponsor's protocol ID
- MoravianU: 22-0028
- Status last verified
- Jan 2023
- First submitted
- 26 Aug 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mao HF, Chen WY, Yao G, Huang SL, Lin CC, Huang WN. Cross-cultural adaptation and validation of the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0): the development of the Taiwanese version. Clin Rehabil. 2010 May;24(5):412-21. doi: 10.1177/0269215509347438.
PubMed 20442253Chodosh J, Edelen MO, Buchanan JL, Yosef JA, Ouslander JG, Berlowitz DR, Streim JE, Saliba D. Nursing home assessment of cognitive impairment: development and testing of a brief instrument of mental status. J Am Geriatr Soc. 2008 Nov;56(11):2069-75. doi: 10.1111/j.1532-5415.2008.01944.x.
PubMed 19016941Law, M., Baptiste, S., Carswell, A., McColl, M. A., Polatajko, H., & Pollock, N. (2014). Canadian Occupational Performance Measure (5th ed.). Ottawa: CAOT Publications.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction of 3D Printed Assistive Devices for Individuals With Physical Disabilities Living in a Long-Term Care Setting
- ClinicalTrials.gov ID
- NCT05519891
- Acronym / sponsor ID
- MoravianU: 22-0028
- Conditions
- Disability Physical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Moravian UniversityUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 29 Aug 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 research aims to examine 3D printed device satisfaction when using mobile devices for individuals with physical disabilities in long-term care facilities, and the impact of the 3D printed device integration on overall occupational performance and satisfaction.
Detailed description
This feasibility study will be conducted at Good Shepherd Rehabilitation Network (GSRN) in the collection of data examining 3D printing outcomes. The 3D printed devices are within the current normal and customary care of GSRN services, with the focus on the created 3D printed adaptations for mobile device usage (i.e. smartphone adaptations). The feasibility data will assist in understanding the satisfaction and performance of 3D printed devices for persons with a physical disability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who are long-term residents of a Good Shepherd residential home, which provides 24 hour services for individuals with life-long physical disabilities, such as Cerebral Palsy, Muscular Dystrophy, Multiple Sclerosis, etc.
Key inclusion criteria (4 listed)
- Being over the age of 18
- Self-identified accessibility needs of the mobile device to address secondary to a physical accessibility limitation(s)
- Accessibility requests of a device that has not already been addressed by 3D printing
- Ownership or borrowing of a mobile device for personal use Operational definition of mobile devices: Mobile devices are a maximum length and width of 9.4" by 6.8" and must weigh less than 1.03 lb (e.g. dimensions of a standard iPad mini) and should be a one-handed use device with touch-screen capabilities
Key exclusion criteria (2 listed)
- Individuals with severe cognitive impairment (BIMS score of 7 or less)
- Individuals who were unwilling to use a 3D printed device
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 |
|---|---|---|
| Custom 3D printed deviceA 3D printed adaptation for a mobile device. | Other | – |
Primary outcome
Canadian Occupational Performance Measure (COPM)
Time frame: 3-4 weeks
As a self-reported measure of occupational performance and occupational satisfaction, the scale ranges from 1-10, with 10 indicating a more favorable outcome in self-rated occupational performance and satisfaction.
1 secondary outcome
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
Time frame: 3-4 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 17 Jan 2023.
- Background: PubMed 20442253Mao HF, Chen WY, Yao G, Huang SL, Lin CC, Huang WN. Cross-cultural adaptation and validation of the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0): the development of the Taiwanese version. Clin Rehabil. 2010 May;24(5):412-21. doi: 10.1177/0269215509347438.
- Background: PubMed 19016941Chodosh J, Edelen MO, Buchanan JL, Yosef JA, Ouslander JG, Berlowitz DR, Streim JE, Saliba D. Nursing home assessment of cognitive impairment: development and testing of a brief instrument of mental status. J Am Geriatr Soc. 2008 Nov;56(11):2069-75. doi: 10.1111/j.1532-5415.2008.01944.x.
- BackgroundLaw, M., Baptiste, S., Carswell, A., McColl, M. A., Polatajko, H., & Pollock, N. (2014). Canadian Occupational Performance Measure (5th ed.). Ottawa: CAOT Publications.
- Individual participant dataSharing planned: Undecided
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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.
Sara Benham, OTD principal investigator
Moravian University
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 Disability Physical, run by Moravian University at 1 site in United States.
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 2 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 17 Jan 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 United States. 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?
Canadian Occupational Performance Measure (COPM) (time frame: 3-4 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 NCT05519891, which also lists 3 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 17 Jan 2023.