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Completed

NCT Number: NCT05275153

Effectiveness of a Home-Based Cognitive Rehabilitation Program in Patients With MCI

In this study, a more specific and systematic Home-Based Cognitive Rehabilitation Program Driven by a Tablet Application is developed and the purpose of the program is to check whether cognitive function is improved when the program is applied to patients with MCI.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, 50610, South Korea

About this study

The subjects of recruitment were the elderly with mild cognitive impairment living in the local community. Assessments were conducted 7 days before and after the intervention. Subjects received Korean-Montreal Cognitive Assessment(MoCA), semantic verbal emory test (SVLT), number memorization test; Digit Span Test (DST), category word fluency test (CWFT), phonemic word fluency test (PWFT), Korean-mini mental state test (K-MMSE), and geriatric depression scale (GDS) before and 8 weeks after the intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women over the age of 55
  • Those who have visual and auditory abilities without difficulties in conducting this research
  • Those with K-MMSE (Korean-Mini Mental State Examination) score of 24 or higher and 16≤K-MoCA score<23
  • In the case of patients taking dementia treatment, those who have the same treatment regimen and dose for 3 months or more from the screening date
  • A person who can understand and respond to the questionnaire questions.
  • A person who voluntarily decided to participate in this study and gave written consent to the informed consent form

Exclusion criteria

  • Those with a history of alcohol or drug abuse,
  • Those with a past history of uniaxial psychiatric disorders, including intellectual disability, schizophrenia, alcoholism, and bipolar disorder
  • A person who is unable to communicate
  • Those who show all neurological symptoms that cause cognitive decline, such as Parkinson's disease, cerebral hemorrhage, brain tumor, and hydrocephalus
  • Those with a record of being unconscious for more than 1 hour due to head trauma or mild repetitive head trauma
  • Those with symptoms of depression that may affect cognitive function

Treatment and study plan

Home based cognitive rehabilitation program

Other

The home based cognitive rehabilitation program intervention was conducted for 30 minutes each time, 3 times a week for 8 weeks, a total of 24 times.

Primary outcomes

  1. Change of the Korean-Montreal cognitive assessment(MoCA) score

    Time frame: Baseline and Week 8

    It is a tool to evaluate overall cognitive function. Possible scores range from 0(lowest cognitive function) to 30 (highest cognitive function). Change = Paired t-test with baseline score and week 8 score.

Secondary outcomes

  1. Change of the semantic verbal emory test (SVLT) score

    Time frame: Baseline and Week 8

    It is a tool to evaluate language memory function. Possible scores range from 0(lowest) to 36 (highest). Change = Paired t-test with baseline score and week 8 score.

  2. Change of the Digit Span Test (DST) score

    Time frame: Baseline and Week 8

    It is a tool to evaluate number memorization and attention. Possible scores range from 0(lowest) to 9 (highest). Change = Paired t-test with baseline score and week 8 score.

  3. Change of the category word fluency test (CWFT) score

    Time frame: Baseline and Week 8

    It is a tool to evaluate executive function. In one minute, the speak words of the given category is performed, and the number of words spoken within the time is evaluated as a score. Change = Paired t-test with baseline score and week 8 score.

  4. Change of the phonemic word fluency test (PWFT) score

    Time frame: Baseline and Week 8

    It is a tool to evaluate executive function. In one minute, the speak words that start with a given phoneme is performed, and the number of words spoken within the time is evaluated as a score. Change = Paired t-test with baseline score and week 8 score.

  5. Change of the geriatric depression scale (GDS) score

    Time frame: Baseline and Week 8

    It is a tool to evaluate degree of depression. Possible scores range from 0(lowest depression) to 21 (highest depression). Change = Paired t-test with baseline score and week 8 score.

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Collaborators

  • Woorisoft

Registry information

Official study title

Effectiveness of a Home-Based Cognitive Rehabilitation Program Driven by a Tablet Application in Patients With Mild Cognitive Impairment

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 11, 2022
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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