- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05519891
3D Printed Assistive Devices for Individuals With Physical Disabilities
January 13, 2023 updated by: Moravian University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sara Benham, OTD
- Phone Number: 610-625-7207
- Email: benhams@moravian.edu
Study Contact Backup
- Name: Jeffrey Bush
- Email: Bushj@moravian.edu
Study Locations
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, United States, 18018
- Moravian University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Individuals with severe cognitive impairment (BIMS score of 7 or less)
- Individuals who were unwilling to use a 3D printed device
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3-4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
Time Frame: 3-4 weeks
|
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.
|
3-4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sara Benham, OTD, Moravian University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Chodosh 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.
- Law, M., Baptiste, S., Carswell, A., McColl, M. A., Polatajko, H., & Pollock, N. (2014). Canadian Occupational Performance Measure (5th ed.). Ottawa: CAOT Publications.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 31, 2022
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
August 26, 2022
First Submitted That Met QC Criteria
August 26, 2022
First Posted (Actual)
August 29, 2022
Study Record Updates
Last Update Posted (Estimate)
January 16, 2023
Last Update Submitted That Met QC Criteria
January 13, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- MoravianU: 22-0028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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