Healthy ElderlyNCT06417034
Hand Training Device For Cognitive Care
A study testing Game Software in people with Healthy Elderly and Mild Cognitive Impairment (MCI), run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Previous studies indicated that auditory stimulation as an external cue might have positive impacts on sensorimotor synchronization. Additionally, according to previous reports apart from traditional interventions, digitized game-based device, such as FTOMBVG, are beneficial for the brain activation in elderly. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Elderly, Mild Cognitive Impairment (MCI)
- What is being tested?
- Game Software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Mar 2022to 11 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Ability to communicate in Mandarin Chinese or Taiwanese
- MCI, according to clinical neurological assessment, Montreal Cognitive Assessment (MoCA):≦25\&≧19
- Ability to perform ADL independently, no hand function disability
- Voluntarily participation and ability to sign the informed consent form
Who cannot join
- Alzheimers disease diagnosed by physicians or meeting the diagnostic criteria for dementia
- Physician's diagnosis of stroke
- Any mental illness or behavior problems and inability to cooperate with the trainer
- Visual impairment or hand diseases resulting in an inability to perform finger press
- received other cognitive or physical training in the past year
- any sight, hearing, or communication impairment
Trial locations and contacts
1 site in 1 country.
About this study
Previous studies indicated that auditory stimulation as an external cue might have positive impacts on sensorimotor synchronization. Additionally, according to previous reports apart from traditional interventions, digitized game-based device, such as FTOMBVG, are beneficial for the brain activation in elderly. Moreover, enhanced finger force control and coordination lead to better hand dexterity and is believed to eventually improve life independence in the healthy elderly and the elderly with cognitive decline. Therefore, this study aims to develop an advanced systems based on the previous one, that can provide hand function rehabilitation, cognitive training, and emotional comfort for the elderly or people suffer from cognitive deficiency. They can enhance their finger force control or visual to motor synchronization by music embedded during the gaming process.
- Conditions
- Healthy Elderly, Mild Cognitive Impairment (MCI)
- Being tested
- Game Software
- Keywords
- Functional near infrared spectroscopy, Parameters of digit force independence, Pressing Evaluation and Training System
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game SoftwareDevice
The software is interfaced with a modified version of Frets on Fire (FOF)-an open source computer game similar to Guitar Hero.
| Study group | Role | What they receive |
|---|---|---|
| Music-based game training | Experimental | Subjects will be asked to press their finger while a series of archery target continuously drop down and pass by the bottom line follow the beats of music melody on Tipr. Receives: Device: Game Software |
| Non music-based game training | Active comparator | The background music will be disabled. Subjects need to press equally amount of force in certain tolerance that been set by only the visual cue on Tipr. Receives: Device: Game Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenated hemoglobin (HbO)
The Oxygenated hemoglobin (HbO) was measured while the participants play the game under both conditions
Measured: 30 minutes
Montreal Cognitive Assessment (MoCA) test
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: Short term memory, Visuospatial abilities, Executive functions, Attention, concentration and working memory, Language, Orientation to time and place. The sensitivity of MoCA for detecting MCI is 90%.
Measured: 10 minutes
EN value
The force independence is collected from the data during force control game in each evaluation session. The parameter of force independence is an index of five digits overall enslaving presented as EN.
Measured: 5 minutes
Secondary outcomes (1)
Maximum voluntary isometric contraction (MVIC)
Maximum voluntary isometric contraction of each digit is measured for training reference.
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start27 Mar 2022
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (62)Papers the sponsor has linked to this study.
- Other trials for Healthy ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fong Chin Su, National Cheng-Kung University Hospital
- Investigators
- Fong-Chin Su, PhD, Principal investigator, Chair Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417034
- Sponsor's protocol ID
- A-ER-110-485
- Status last verified
- May 2024
- First submitted
- 12 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Organization, W.H., Global health and aging. Geneva: World Health Organization, 2011.
Olshansky SJ, Ault AB. The fourth stage of the epidemiologic transition: the age of delayed degenerative diseases. Milbank Q. 1986;64(3):355-91.
PubMed 3762504Sun Y, Lee HJ, Yang SC, Chen TF, Lin KN, Lin CC, Wang PN, Tang LY, Chiu MJ. A nationwide survey of mild cognitive impairment and dementia, including very mild dementia, in Taiwan. PLoS One. 2014 Jun 18;9(6):e100303. doi: 10.1371/journal.pone.0100303. eCollection 2014.
PubMed 24940604Wimo A, Guerchet M, Ali GC, Wu YT, Prina AM, Winblad B, Jonsson L, Liu Z, Prince M. The worldwide costs of dementia 2015 and comparisons with 2010. Alzheimers Dement. 2017 Jan;13(1):1-7. doi: 10.1016/j.jalz.2016.07.150. Epub 2016 Aug 29.
PubMed 27583652Langa KM, Levine DA. The diagnosis and management of mild cognitive impairment: a clinical review. JAMA. 2014 Dec 17;312(23):2551-61. doi: 10.1001/jama.2014.13806.
PubMed 25514304Maioli F, Coveri M, Pagni P, Chiandetti C, Marchetti C, Ciarrocchi R, Ruggero C, Nativio V, Onesti A, D'Anastasio C, Pedone V. Conversion of mild cognitive impairment to dementia in elderly subjects: a preliminary study in a memory and cognitive disorder unit. Arch Gerontol Geriatr. 2007;44 Suppl 1:233-41. doi: 10.1016/j.archger.2007.01.032.
PubMed 17317458Abou Kassm S, Naja W, Hoertel N, Limosin F. [Pharmacological management of delusions associated with dementia]. Geriatr Psychol Neuropsychiatr Vieil. 2019 Sep 1;17(3):317-326. doi: 10.1684/pnv.2019.0813. French.
PubMed 31449050Folch J, Busquets O, Ettcheto M, Sanchez-Lopez E, Castro-Torres RD, Verdaguer E, Garcia ML, Olloquequi J, Casadesus G, Beas-Zarate C, Pelegri C, Vilaplana J, Auladell C, Camins A. Memantine for the Treatment of Dementia: A Review on its Current and Future Applications. J Alzheimers Dis. 2018;62(3):1223-1240. doi: 10.3233/JAD-170672.
PubMed 29254093Groot C, Hooghiemstra AM, Raijmakers PG, van Berckel BN, Scheltens P, Scherder EJ, van der Flier WM, Ossenkoppele R. The effect of physical activity on cognitive function in patients with dementia: A meta-analysis of randomized control trials. Ageing Res Rev. 2016 Jan;25:13-23. doi: 10.1016/j.arr.2015.11.005. Epub 2015 Nov 28.
PubMed 26607411Brasure M, Desai P, Davila H, Nelson VA, Calvert C, Jutkowitz E, Butler M, Fink HA, Ratner E, Hemmy LS, McCarten JR, Barclay TR, Kane RL. Physical Activity Interventions in Preventing Cognitive Decline and Alzheimer-Type Dementia: A Systematic Review. Ann Intern Med. 2018 Jan 2;168(1):30-38. doi: 10.7326/M17-1528. Epub 2017 Dec 19.
PubMed 29255839Baird A, Samson S. Music and dementia. Prog Brain Res. 2015;217:207-35. doi: 10.1016/bs.pbr.2014.11.028. Epub 2015 Jan 31.
PubMed 25725917Woods B, O'Philbin L, Farrell EM, Spector AE, Orrell M. Reminiscence therapy for dementia. Cochrane Database Syst Rev. 2018 Mar 1;3(3):CD001120. doi: 10.1002/14651858.CD001120.pub3.
PubMed 29493789Spector A, Orrell M, Woods B. Cognitive Stimulation Therapy (CST): effects on different areas of cognitive function for people with dementia. Int J Geriatr Psychiatry. 2010 Dec;25(12):1253-8. doi: 10.1002/gps.2464.
PubMed 20069533Spector A, Orrell M, Davies S, Woods B. Reality orientation for dementia. Cochrane Database Syst Rev. 2000;(4):CD001119. doi: 10.1002/14651858.CD001119.
PubMed 11034699Diaz-Perez E, Florez-Lozano JA. [Virtual reality and dementia]. Rev Neurol. 2018 May 16;66(10):344-352. Spanish.
PubMed 29749595
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Training Device For Cognitive Care
- ClinicalTrials.gov ID
- NCT06417034
- Acronym / sponsor ID
- A-ER-110-485
- Conditions
- Healthy Elderly, Mild Cognitive Impairment (MCI)
- Keywords
- Functional near infrared spectroscopy, Parameters of digit force independence, Pressing Evaluation and Training System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 27 Mar 2022 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies indicated that auditory stimulation as an external cue might have positive impacts on sensorimotor synchronization. Additionally, according to previous reports apart from traditional interventions, digitized game-based device, such as FTOMBVG, are beneficial for the brain activation in elderly. Moreover, enhanced finger force control and coordination lead to better hand dexterity and is believed to eventually improve life independence in the healthy elderly and the elderly with cognitive decline. Therefore, this study aims to develop an advanced systems based on the previous one, that can provide hand function rehabilitation, cognitive training, and emotional comfort for the elderly or people suffer from cognitive deficiency. They can enhance their finger force control or visual to motor synchronization by music embedded during the gaming process.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music-based game training | Experimental | Device: Game SoftwareSubjects will be asked to press their finger while a series of archery target continuously drop down and pass by the bottom line follow the beats of music melody on Tipr. |
| Non music-based game training | Active comparator | Device: Game SoftwareThe background music will be disabled. Subjects need to press equally amount of force in certain tolerance that been set by only the visual cue on Tipr. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Ability to communicate in Mandarin Chinese or Taiwanese
- MCI, according to clinical neurological assessment, Montreal Cognitive Assessment (MoCA):≦25\&≧19
- Ability to perform ADL independently, no hand function disability
- Voluntarily participation and ability to sign the informed consent form
Key exclusion criteria (6 listed)
- Alzheimers disease diagnosed by physicians or meeting the diagnostic criteria for dementia
- Physician's diagnosis of stroke
- Any mental illness or behavior problems and inability to cooperate with the trainer
- Visual impairment or hand diseases resulting in an inability to perform finger press
- received other cognitive or physical training in the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game SoftwareThe software is interfaced with a modified version of Frets on Fire (FOF)-an open source computer game similar to Guitar Hero. | Device | Music-based game training, Non music-based game training |
Primary outcome
Oxygenated hemoglobin (HbO)
Time frame: 30 minutes
The Oxygenated hemoglobin (HbO) was measured while the participants play the game under both conditions
Montreal Cognitive Assessment (MoCA) test
Time frame: 10 minutes
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: Short term memory, Visuospatial abilities, Executive functions, Attention, concentration and working memory, Language, Orientation to time and place. The sensitivity of MoCA for detecting MCI is 90%.
EN value
Time frame: 5 minutes
The force independence is collected from the data during force control game in each evaluation session. The parameter of force independence is an index of five digits overall enslaving presented as EN.
1 secondary outcome
Maximum voluntary isometric contraction (MVIC)
Time frame: 10 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- BackgroundOrganization, W.H., Global health and aging. Geneva: World Health Organization, 2011.
- Background: PubMed 3762504Olshansky SJ, Ault AB. The fourth stage of the epidemiologic transition: the age of delayed degenerative diseases. Milbank Q. 1986;64(3):355-91.
- Background: PubMed 24940604Sun Y, Lee HJ, Yang SC, Chen TF, Lin KN, Lin CC, Wang PN, Tang LY, Chiu MJ. A nationwide survey of mild cognitive impairment and dementia, including very mild dementia, in Taiwan. PLoS One. 2014 Jun 18;9(6):e100303. doi: 10.1371/journal.pone.0100303. eCollection 2014.
- Background: PubMed 27583652Wimo A, Guerchet M, Ali GC, Wu YT, Prina AM, Winblad B, Jonsson L, Liu Z, Prince M. The worldwide costs of dementia 2015 and comparisons with 2010. Alzheimers Dement. 2017 Jan;13(1):1-7. doi: 10.1016/j.jalz.2016.07.150. Epub 2016 Aug 29.
- Background: PubMed 25514304Langa KM, Levine DA. The diagnosis and management of mild cognitive impairment: a clinical review. JAMA. 2014 Dec 17;312(23):2551-61. doi: 10.1001/jama.2014.13806.
- Background: PubMed 17317458Maioli F, Coveri M, Pagni P, Chiandetti C, Marchetti C, Ciarrocchi R, Ruggero C, Nativio V, Onesti A, D'Anastasio C, Pedone V. Conversion of mild cognitive impairment to dementia in elderly subjects: a preliminary study in a memory and cognitive disorder unit. Arch Gerontol Geriatr. 2007;44 Suppl 1:233-41. doi: 10.1016/j.archger.2007.01.032.
- Background: PubMed 31449050Abou Kassm S, Naja W, Hoertel N, Limosin F. [Pharmacological management of delusions associated with dementia]. Geriatr Psychol Neuropsychiatr Vieil. 2019 Sep 1;17(3):317-326. doi: 10.1684/pnv.2019.0813. French.
- Background: PubMed 29254093Folch J, Busquets O, Ettcheto M, Sanchez-Lopez E, Castro-Torres RD, Verdaguer E, Garcia ML, Olloquequi J, Casadesus G, Beas-Zarate C, Pelegri C, Vilaplana J, Auladell C, Camins A. Memantine for the Treatment of Dementia: A Review on its Current and Future Applications. J Alzheimers Dis. 2018;62(3):1223-1240. doi: 10.3233/JAD-170672.
- Background: PubMed 26607411Groot C, Hooghiemstra AM, Raijmakers PG, van Berckel BN, Scheltens P, Scherder EJ, van der Flier WM, Ossenkoppele R. The effect of physical activity on cognitive function in patients with dementia: A meta-analysis of randomized control trials. Ageing Res Rev. 2016 Jan;25:13-23. doi: 10.1016/j.arr.2015.11.005. Epub 2015 Nov 28.
- Background: PubMed 29255839Brasure M, Desai P, Davila H, Nelson VA, Calvert C, Jutkowitz E, Butler M, Fink HA, Ratner E, Hemmy LS, McCarten JR, Barclay TR, Kane RL. Physical Activity Interventions in Preventing Cognitive Decline and Alzheimer-Type Dementia: A Systematic Review. Ann Intern Med. 2018 Jan 2;168(1):30-38. doi: 10.7326/M17-1528. Epub 2017 Dec 19.
- Background: PubMed 25725917Baird A, Samson S. Music and dementia. Prog Brain Res. 2015;217:207-35. doi: 10.1016/bs.pbr.2014.11.028. Epub 2015 Jan 31.
- Background: PubMed 29493789Woods B, O'Philbin L, Farrell EM, Spector AE, Orrell M. Reminiscence therapy for dementia. Cochrane Database Syst Rev. 2018 Mar 1;3(3):CD001120. doi: 10.1002/14651858.CD001120.pub3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fong-Chin Su, PhD principal investigator
Chair Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game Software in people with Healthy Elderly and Mild Cognitive Impairment (MCI), run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenated hemoglobin (HbO) (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06417034, which also lists 62 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.