3D Printed Assistive Devices for Individuals With Physical Disabilities

Disability Physical Clinical Trial

Official title:

Satisfaction of 3D Printed Assistive Devices for Individuals With Physical Disabilities Living in a Long-Term Care Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05519891
• Other study ID #: MoravianU: 22-0028
• Status: Completed
• Start date: August 31, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Moravian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Being over the age of 18

2. Self-identified accessibility needs of the mobile device to address secondary to a physical accessibility limitation(s)

3. Accessibility requests of a device that has not already been addressed by 3D printing

4. 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:

1. Individuals with severe cognitive impairment (BIMS score of 7 or less)

2. Individuals who were unwilling to use a 3D printed device

Related Conditions & MeSH terms

• Disability Physical

Intervention

Other:
• Custom 3D printed device
A 3D printed adaptation for a mobile device.

Locations

Country	Name	City	State
United States	Moravian University	Bethlehem	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Moravian University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Law, M., Baptiste, S., Carswell, A., McColl, M. A., Polatajko, H., & Pollock, N. (2014). Canadian Occupational Performance Measure (5th ed.). Ottawa: CAOT 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3-4 weeks
Secondary	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.	3-4 weeks