Hand Training Device For Cognitive Care

Mild Cognitive Impairment (MCI) Clinical Trial

Official title:

Hand Training Device For Cognitive Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06417034
• Other study ID #: A-ER-110-485
• Status: Completed
• Phase: N/A
• Start date: March 27, 2022
• Est. completion date: April 11, 2022

Study information

• Verified date: May 2024
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 11, 2022
• Est. primary completion date: April 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Healthy Elderly
• Mild Cognitive Impairment (MCI)

Intervention

Device:
• Game Software
The software is interfaced with a modified version of Frets on Fire (FOF)-an open source computer game similar to Guitar Hero.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

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* Note: There are 62 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygenated hemoglobin (HbO)	The Oxygenated hemoglobin (HbO) was measured while the participants play the game under both conditions	30 minutes
Primary	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%.	10 minutes
Primary	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.	5 minutes
Secondary	Maximum voluntary isometric contraction (MVIC)	Maximum voluntary isometric contraction of each digit is measured for training reference.	10 seconds