- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02388451
The Benefits of the Use of the Feuerstein Cognitive Training Method on Cognitive Function in Community-dwelling Older Patients With Mild Cognitive Impairment: a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The rise in life expectancy in recent decades has resulted in a dramatic increase in the population of older people. This has been associated with a rise in the prevalence of age-associated conditions, particularly cognitive impairment and dementia. The prevalence of dementia in those older than 65 doubles every five years, and reaches a rate of more than 40% at age 85 years. Data from the World Health Organization predict 43 million dementia sufferers globally in the year 2020.
Mild Cognitive Impairment (MCI) is a syndrome comprising cognitive symptoms and impairment beyond population norms based on age and education, without functional loss. MCI represents a risk factor for dementia at a rate of conversion of approximately 12% annually. Thus patients with MCI characterize an important group for possible interventions in preventing further cognitive decline, particularly physical exercise and cognitive training.
The Feuerstein Program The Feuerstein Instrumental Enrichment (IE) program has been well-established as an effective intervention in other age groups and clinical situations. The method's creator, Professor Reuven Feuerstein, postulated that the thinking process is divided into three major phases - Input, Elaboration and Output - and that in each phase, different mental functions are at work. The quality of thinking depends upon the way the different functions are activated in each of the phases. The IE tools enable the correction or activation of cognitive deficiencies through use of targeted and focused mediation, which conserves and reinforces cognitive ability.
Recently, the Feuerstein Instrumental Enrichment Program for the Elderly was developed particularly for older people with cognitive decline.
Instrumental Enrichment can benefit all senior citizens, but is particularly recommended for those who do not constantly face intellectual challenges.
The process of learning IE is administered in group settings by instructors who have been trained to specifically mediate to the geriatric population. Work in groups constitutes a challenging, interesting and gratifying activity. It also appears that beyond contributing to the conservation and improvement of cognition, participating in the program may also have the effect of increasing feelings of competence, independence and improved emotional state.
15 subjects conforming to inclusion and exclusion criteria with a known clinical diagnosis of MCI and who provide informed consent will undergo cognitive and functional assessment to confirm the diagnosis of MCI. Baseline assessment using the Mindstreams Mild Cognitive Impairment Computerized Assessment Battery will be performed. Subjects will then participate 30 twice weekly meetings of 90 minutes duration each (for a total of 15 weeks). Mindstreams testing will be repeated after 15 sessions and at completion of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beer-Sheva, Israel
- Yan Press
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 65 years and older
- Able to read and speak Hebrew
- Provide informed consent for participation in the study
- Clinical diagnosis of MCI based on Consensus Criteria
- A score of lower than 95 on the Memory Index of the Mindstreams Mild Cognitive Impairment Computerized Assessment Battery
Exclusion Criteria:
- A medical condition (such as advanced heart failure, unstable ischemic heart disease, a lung condition with dyspnea on mild effort, intractable pain) or functional impairment (especially limiting mobility without the home) that does not allow the subject to participate in the training activities for the full duration of the study
- A diagnosis of depression, bipolar disorder or schizophrenia
- A cognitive diagnosis other than MCI, such as delirium, dementia or mental retardation
- Visual impairment not corrected by the use of spectacles
- Hearing impairment not corrected by hearing aids
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Feuerstein Program
15 subjects conforming to inclusion and exclusion criteria with a known clinical diagnosis of MCI and who provide informed consent will undergo cognitive and functional assessment to confirm the diagnosis of MCI.
Baseline assessment using the Mindstreams Mild Cognitive Impairment Computerized Assessment Battery will be performed.
Subjects will then participate 30 twice weekly meetings of 90 minutes duration each (for a total of 15 weeks).
Mindstreams testing will be repeated after 15 sessions and at completion of the study.
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The IE activity is administered by instructors in groups of 10 to 15 participants.
The intervention comprises 30 twice weekly meetings of 90 minutes duration per group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mindstreams Mild Cognitive Impairment Computerized Assessment Battery
Time Frame: Change from Baseline Cognitive Function at 15 weeks
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The Mindstreams Mild Cognitive Impairment Computerized Assessment Battery developed by Neurotrax Corp. provides index scores in multiple cognitive domains, as well as a Global cognitive score
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Change from Baseline Cognitive Function at 15 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (NavyGHB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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