Dementia Alzheimers Clinical Trial
Official title:
Developing an Immersive Gamification Technology System (ImGTS) for the Management of Patients With Behavioral and Psychological Symptoms of Dementia (Phase 1 Trial)
NCT number | NCT05265182 |
Other study ID # | AXEL0001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 28, 2022 |
Est. completion date | July 26, 2022 |
Verified date | July 2022 |
Source | Augmented eXperience E-health Laboratory |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The proposed research project aims to answer the question "Are immersive technology systems effective in the management and treatment of patients with BPSD?". This project is composed of three phases and the current study is the first phase. The phase 1 trial aims to create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its acceptability, usability, and safety in the healthy adult population.
Status | Completed |
Enrollment | 30 |
Est. completion date | July 26, 2022 |
Est. primary completion date | July 26, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 59 Years |
Eligibility | Inclusion Criteria: - Aged 40 to 59 years old - Montreal Cognitive Assessment-Philippine Version (MoCA-P) score > 20 - Neuropsychiatric Inventory (NPI) score of 0 - Able to understand Filipino and English Exclusion Criteria: - Previously diagnosed with dementia - Receptive aphasia - Previously diagnosed with a psychiatric disorder - Previously diagnosed with seizures or epilepsy - Significant visual and hearing impairment - Has a history of motion sickness - Quadriplegia or paralysis of dominant hand - Life expectancy of less than a year |
Country | Name | City | State |
---|---|---|---|
Philippines | College of Allied Medical Professions Clinic for Therapy Services | City Of Manila | National Capital Region |
Lead Sponsor | Collaborator |
---|---|
Augmented eXperience E-health Laboratory |
Philippines,
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Clay F, Howett D, FitzGerald J, Fletcher P, Chan D, Price A. Use of Immersive Virtual Reality in the Assessment and Treatment of Alzheimer's Disease: A Systematic Review. J Alzheimers Dis. 2020;75(1):23-43. doi: 10.3233/JAD-191218. — View Citation
Coelho T, Marques C, Moreira D, Soares M, Portugal P, Marques A, Ferreira AR, Martins S, Fernandes L. Promoting Reminiscences with Virtual Reality Headsets: A Pilot Study with People with Dementia. Int J Environ Res Public Health. 2020 Dec 12;17(24):9301. doi: 10.3390/ijerph17249301. — View Citation
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Dominguez J, Fe de Guzman M, Reandelar M, Thi Phung TK. Prevalence of Dementia and Associated Risk Factors: A Population-Based Study in the Philippines. J Alzheimers Dis. 2018;63(3):1065-1073. doi: 10.3233/JAD-180095. — View Citation
Dominguez JC, Orquiza MG, Soriano JR, Magpantay CD, Esteban RC, Corrales ML, Ampil ER. Adaptation of the Montreal Cognitive Assessment for elderly Filipino patients. East Asian Arch Psychiatry. 2013 Sep;23(3):80-5. — View Citation
Kales HC, Gitlin LN, Lyketsos CG. Assessment and management of behavioral and psychological symptoms of dementia. BMJ. 2015 Mar 2;350:h369. doi: 10.1136/bmj.h369. — View Citation
Kim O, Pang Y, Kim JH. The effectiveness of virtual reality for people with mild cognitive impairment or dementia: a meta-analysis. BMC Psychiatry. 2019 Jul 12;19(1):219. doi: 10.1186/s12888-019-2180-x. — View Citation
Manera V, Chapoulie E, Bourgeois J, Guerchouche R, David R, Ondrej J, Drettakis G, Robert P. A Feasibility Study with Image-Based Rendered Virtual Reality in Patients with Mild Cognitive Impairment and Dementia. PLoS One. 2016 Mar 18;11(3):e0151487. doi: 10.1371/journal.pone.0151487. eCollection 2016. — View Citation
Mendez MF, Joshi A, Jimenez E. Virtual reality for the assessment of frontotemporal dementia, a feasibility study. Disabil Rehabil Assist Technol. 2015 Mar;10(2):160-4. doi: 10.3109/17483107.2014.889230. Epub 2014 Feb 14. — View Citation
Moyle W, Jones C, Dwan T, Petrovich T. Effectiveness of a Virtual Reality Forest on People With Dementia: A Mixed Methods Pilot Study. Gerontologist. 2018 May 8;58(3):478-487. doi: 10.1093/geront/gnw270. — View Citation
Optale G, Urgesi C, Busato V, Marin S, Piron L, Priftis K, Gamberini L, Capodieci S, Bordin A. Controlling memory impairment in elderly adults using virtual reality memory training: a randomized controlled pilot study. Neurorehabil Neural Repair. 2010 May;24(4):348-57. doi: 10.1177/1545968309353328. Epub 2009 Nov 24. — View Citation
Strong J. Immersive Virtual Reality and Persons with Dementia: A Literature Review. J Gerontol Soc Work. 2020 Apr;63(3):209-226. doi: 10.1080/01634372.2020.1733726. Epub 2020 Feb 24. — View Citation
Thapa N, Park HJ, Yang JG, Son H, Jang M, Lee J, Kang SW, Park KW, Park H. The Effect of a Virtual Reality-Based Intervention Program on Cognition in Older Adults with Mild Cognitive Impairment: A Randomized Control Trial. J Clin Med. 2020 Apr 29;9(5):1283. doi: 10.3390/jcm9051283. — View Citation
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of cybersickness will be assessed using the Virtual Reality Sickness Questionnaire. | A 9-item Virtual Reality Sickness Questionnaire to assess cybersickness. | Immediately after each intervention, within an hour of completion of the virtual reality game. | |
Primary | The acceptability of the design will be measured using the Place Probe. | The Place Probe is a sense of place questionnaire. | Immediately after each intervention, within an hour of completion of the virtual reality game. | |
Primary | The rate of usability will be performed according to the Philippine National Standards ISO/IEC Metrics. | The goal is to provide continuous improvement in the design and user experience to maximize the three components of usability: effectiveness, efficiency, and satisfaction. | Within an hour of the end of the study. |
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