NCT05519891

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

August 31, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

August 26, 2022

Last Update Submit

January 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)

    3-4 weeks

Interventions

A 3D printed adaptation for a mobile device.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Individuals with severe cognitive impairment (BIMS score of 7 or less)
  • Individuals who were unwilling to use a 3D printed device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moravian University

Bethlehem, Pennsylvania, 18018, United States

Location

Related Publications (3)

  • 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.

    PMID: 20442253BACKGROUND
  • 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.

    PMID: 19016941BACKGROUND
  • Law, M., Baptiste, S., Carswell, A., McColl, M. A., Polatajko, H., & Pollock, N. (2014). Canadian Occupational Performance Measure (5th ed.). Ottawa: CAOT Publications.

    BACKGROUND

Study Officials

  • Sara Benham, OTD

    Moravian University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2022

First Posted

August 29, 2022

Study Start

August 31, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

January 17, 2023

Record last verified: 2023-01

Locations