Recruiting

3D Printing

Sponsor:

Moai Technologies LLC

Code:

NCT03625973

Conditions

Dementia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

3D-RT

RT-Verbal

Study Details

Brief summary:

In 2013 an estimated 5 million people age 65 and older had Alzheimer's disease. Longer life spans and aging baby boomers will cause this number to grow rapidly. More than 50% of residents in assisted living and nursing homes have some form of dementia or cognitive impairment and the number is increasing every day.

As a form of person-centered, non-pharmacological dementia care, Reminiscence Therapy (RT) holds considerable promise. Improvements in mood, quality of life, social interaction, cognition, memory and a reduction in caregiver stress have been noted. This project will develop an operational model for identifying and producing 3D personal objects using 3D printing technology, and deploying them for use in RT. The research also will evaluate the effectiveness of using 3D-printed objects in RT compared to other types of memory stimuli. This novel approach to the "personalization" of reminiscence therapy will result in better social and mental health outcomes for individuals with dementia.

Conditions

Dementia

Study ID

NCT03625973

Start date

Nov 30, 2021

Status verified date

Apr, 2022

Completion date

Nov 30, 2022

Anticipated

Primary completion date

Nov 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. English speaking
2. Physician diagnosis of early-stage Alzheimer's disease or mild cognitive impairment
3. Score of 10 or above on the brief St. Louis University Mental Status examination (SLUMS).

Exclusion Criteria:

-

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 16 Weeks of 3D-RT

Participants will receive 16 weeks of Reminiscence Therapy using 3D printed objects as stimuli.

experimental: 8 Weeks of 3D-RT

Participants will receive 8weeks of Reminiscence Therapy using 3D printed objects as stimuli and 8 weeks of RT using verbal stimuli.

active comparator: 16 Weeks of RT using Verbal Stimuli

Participants will receive 16 weeks of RT using verbal stimuli to reminiscence.

Interventions

3D-RT

Objects printed using 3D printing media will be used as stimuli in Reminiscence Therapy

RT-Verbal

Verbal cues will be used as stimuli in Reminiscence Therapy

Primary outcome measure

  • Change in Cognitive stimulation/reminiscence [ Time Frame: Will be administered at Week 0 (prior to first therapy session) to establish a baseline. Measures at Week 8 (midpoint of therapy sessions), and Week 16 (following last therapy session) will determine change from the baseline. ]

Central Contacts and Locations

Central contacts

Thomas Havey, MBA, JD

763 515 5333moaitechnologies@gmail.com

Olu Olofinboba, MS

9529944935olu@ieee.org

Locations

Saint Louis University

Recruiting

Saint Louis, Missouri, United States, 63103-1021

University of Texas Arlington

Recruiting

Arlington, Texas, United States, 76019

More Information

Sponsor

Moai Technologies LLC

Last update posted

Apr 25, 2022

Last verified

Apr, 2022

Keywords

  • Dementia
  • Memory, Episodic
  • Printing, Three-Dimensional

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Moai Technologies LLC on 2022-04-25.