Intellectual Disability Clinical Trial
Official title:
The Effectiveness and Feasibility of Tablet-based Interactive Games in Elderly With Cognitive Impairment and Persons With Intellectual Disability: A Randomised Controlled Trial
Verified date | November 2023 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study has 10 research questions regarding the cognitive training program and tablet-based interactive games: Primary study questions: 1. Can the participation of 12-week cognitive training program using tablet-based interactive games maintain cognitive functioning? Secondary study questions: 2. Can the participation of 12-week cognitive training program using tablet-based interactive games improve the scores of 6 supplier-developed cognitive domains (including executive function, memory, eye-hand coordination, attention, visual-spatial ability, language)? 3. Can the participation of 12-week cognitive training program using tablet-based interactive games improve the reaction time of the participants? 4. What is the attendance rate in the cognitive training program, and for how long do the participants play the tablet-based interactive games? 5. What is the usability and acceptability of the tablet-based interactive games? Auxiliary study questions: 6. Can the participation of 12-week cognitive training program using tablet-based interactive games reduce neuropsychiatric symptoms? 7. Can the participation of 12-week cognitive training program using tablet-based interactive games improve upper-body flexibility? 8. What are the physical side effects of using digital devices in the 12-week cognitive training program? 9. What are the perceived benefits and feasibility of the cognitive training program and tablet-based interactive games? 10. Can the participation of 12-week cognitive training program using tablet-based interactive games improve activities of daily living of persons with intellectual disability?
Status | Completed |
Enrollment | 68 |
Est. completion date | November 10, 2023 |
Est. primary completion date | November 8, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: Inclusion criteria for the service users in elderly service setting: - Diagnosed with mild to moderate dementia by doctors, or scoring at least 5 and lower than the norm-derived age and education adjusted cutoff scores 7th percentile in HK-MoCA (i.e. elderly with MCI, mild dementia and moderate dementia), and - Able to understand Chinese Inclusion criteria for the service users in rehabilitation service setting: - Aged 40 or above, - Diagnosed with intellectual disability (IQ<70), and - Able to understand Chinese Inclusion criteria for the program facilitators: - Occupational therapists of the study sites (preferably), or - Social workers or nurses of the study sites Exclusion Criteria: Exclusion criteria for both types of service users: • Inability to join the intervention program due to severe mental illness, behavior problems, sight impairment, hearing impairment, or communication impairment, as determined by the program facilitator Exclusion criteria for the program facilitators: • Nil |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Haven of Hope Day Care cum Rehabilitation Centre for Elderly (Hong Kong West/ Hong Kong East) | Hong Kong | |
Hong Kong | Haven of Hope Nursing Home | Hong Kong | |
Hong Kong | Haven of Hope Rehabilitation Services for Disabled | Hong Kong | |
Hong Kong | Haven of Hope Sister Annie Skau Holistic Care Centre | Hong Kong | |
Hong Kong | Haven of Hope Woo Ping Care & Attention Home | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong | Haven of Hope Hospital, The Social Innovation and Entrepreneurship Development Fund, Hong Kong |
Hong Kong,
Chiu HFK, Zhong BL, Leung T, Li SW, Chow P, Tsoh J, Yan C, Xiang YT, Wong M. Development and validation of a new cognitive screening test: The Hong Kong Brief Cognitive Test (HKBC). Int J Geriatr Psychiatry. 2018 Jul;33(7):994-999. doi: 10.1002/gps.4883. Epub 2018 Apr 11. — View Citation
Katz-Leurer M, Fisher I, Neeb M, Schwartz I, Carmeli E. Reliability and validity of the modified functional reach test at the sub-acute stage post-stroke. Disabil Rehabil. 2009;31(3):243-8. doi: 10.1080/09638280801927830. — View Citation
Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233. — View Citation
MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available. — View Citation
Tyrer SP, Wigham A, Cicchetti D, Margallo-Lana M, Moore PB, Reid BE. Comparison of short and long versions of the Prudhoe Cognitive Function Test and the K-BIT in participants with intellectual impairment. J Autism Dev Disord. 2010 Aug;40(8):1000-5. doi: 10.1007/s10803-010-0949-3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of cognitive functioning of elderly without intellectual disability before and after using the tablet-based interactive games | Change of cognitive functioning of elderly without intellectual disability before and after using the tablet-based interactive games will be assessed by HKU research staff who is blinded to group allocation. Total nine items on Hong Kong Brief Cognitive Test (HKBC) will be completed at the baseline and the end of 12-week trial period and the minimum and maximum scores are 0 and 30 respectively. | Baseline and at the end of 12-week trial period | |
Primary | Change of cognitive functioning of person with intellectual disability before and after using the tablet-based interactive games | Change of cognitive functioning of person with intellectual disability before and after using the tablet-based interactive games will be assessed by HKU research staff who is blinded to the group allocation. Total twenty-one items on 21-item Short Form of the Prudhoe Cognitive Function Test (SF-PCFT) will be completed at the baseline and the end of 12-week trial period and the minimum and maximum scores are 0 and 30 respectively. | Baseline and at the end of 12-week trial period | |
Secondary | The scores of 6 supplier-developed cognitive domains | The scores of 6 supplier-developed cognitive domains (including executive function, memory, eye-hand coordination, attention, visual-spatial ability, language) in the tablet-based interactive games will be calculated by the game system throughout the program and provided by the supplier. | From the start to the end of 12-week trial period | |
Secondary | Change of reaction time before and after using the tablet-based interactive games | Change of reaction time before and after using the tablet-based interactive games will be assessed by HKU research staff who is blinded to the group allocation. Human Benchmark: Reaction time (https://humanbenchmark.com/tests/reactiontime) will be used to assess at the baseline and the end of 12-week trial period. In each assessment, the participants will undergo the test for four trials. The average reaction time in terms of mini-seconds of the trials will be recorded. | Baseline and at the end of 12-week trial period | |
Secondary | Attendance rate in the cognitive training program (including facilitated and non-facilitated sessions) | Attendance rate in cognitive training program (including facilitated and non-facilitated sessions) will be recorded by the game system and provided by the supplier. | From the start to the end of 12-week trial period | |
Secondary | Time spent on playing tablet-based interactive games | Time (in terms of minutes and seconds) spent on playing tablet-based interactive games will be recorded by the game system and provided by the supplier. | From the start to the end of 12-week trial period | |
Secondary | The usability and acceptability of the tablet-based interactive games | Participants and program facilitators or the next of kin of participants will complete thirteen items indicating the usability and acceptability of the tablet-based interactive games on a 5-point Likert scale (i.e. 1 indicating strongly disagree and 5 indicating strongly agree). The minimum and maximum values of the scale are 13 and 65 respectively, with higher score indicating higher usability and acceptability of games. | At the end of the 12-week cognitive training program | |
Secondary | Change of neuropsychiatric symptoms before and after using the tablet-based interactive games | Change of neuropsychiatric symptoms of using the tablet-based interactive games for 12 weeks will be measured by Neuropsychiatric Inventory Questionnaire (NPI-Q). Program facilitators will complete twelve items. The range of the severity scale is 12 to 36, with higher score indicating more severe neuropsychiatric symptoms. The range of the caregiver distress scale is 0 to 60, with higher score indicating higher caregiver distress. | Baseline and at the end of 12-week trial period | |
Secondary | Change of upper-body flexibility before and after using the tablet-based interactive games | Change of upper-body flexibility before and after using the tablet-based interactive games will be assessed by HKU research staff who is blinded to the group allocation. The assessments of upper-body flexibility measured by Functional Reach Test. The distance in unit of centimeter of arm reach will be recorded. | Baseline and at the end of 12-week trial period | |
Secondary | Change of physical side effects before and after using digital device | Change of physical side effects of using digital device for 12 weeks will be measured by four items on 1. sleepless/restless sleep patterns, 2. red eyes/eye irritation/ dryness eyes, 3. shoulder or neck pain/sore muscle, and 4. retinal disease/eye pain, with 0 indicating no symptom and 2 indicating always having symptom. The minimum and maximum values of the scale are 0 and 8 respectively, with higher score indicating more physical side effects of using digital devices. | Baseline and at the end of 12-week trial period | |
Secondary | Qualitative measures: The perceived benefits and feasibility of the cognitive training program and tablet-based interactive games of participants | A total of 2-3 participants who can communicate from each test site will be invited to participate in the qualitative interview. The contents include:
What do you think about the tablet-based interactive games? What do you think about the cognitive training program? Do you want to continue to play the tablet-based interactive games in the future? Do you want to join if service unit arranges similar cognitive training program? |
At the end of 12-week trial period | |
Secondary | Qualitative measures: The perceived benefits and feasibility of the cognitive training program and tablet-based interactive games of program facilitators | All program facilitators will be invited to participate in the qualitative interview. The contents include:
What do you think about the local elements of cognitive game? Were the participants willing to play the cognitive games? Was there any improvement on cognitive functioning after the intervention program? Is it safe to play game? Is it easy to play game? Was there any abnormal situation during the trial period? Was the problem solved? Do you think the cognitive game can help on the cognitive training? What was the reaction of participants? What were your concern before playing games? Did the cognitive game fulfill your expectation? On the whole, are you satisfied with the games? To what extent, do you want the service users to continue to play the games? Do you think the time and number of scheduled training sessions was opportune? Would you recommend the games to others? |
At the end of 12-week trial period | |
Secondary | Change of the activities in daily living of person with intellectual disability before and after using the tablet-based interactive games | Change of the activities in daily living of all participants in rehabilitation setting will be assessed by program facilitators of the study sites. Total ten items on the Barthel Index will be completed at the baseline and the end of 12-week trial period. The minimum and maximum scores are 0 and 100 respectively, with lower score indicating higher level of dependence. | Baseline and at the end of 12-week trial period |
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