Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Impairment and Balance in Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02051270
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
One important issue in older adults with cognitive problems is the higher risk of fall due to decreased motor function and balance. The objective of this study is to evaluate the repercussions of mild cognitive impairment in balance in elderly.

Condition or disease Intervention/treatment
Mild Cognitive Impairment Other: Descriptive study

Detailed Description:
Mild cognitive impairment is described as a transitional stage between normal ageing and dementia, and reflects the clinical situation where a person has memory complaints and objective evidence of cognitive impairment but no evidence of dementia. Mild cognitive is important in older people and it is also important to evaluate its repercussion in balance.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Mild Cognitive Impairment and Balance in Elderly
Study Start Date : January 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Elders
Older people living in nursing homes will undergo a descriptive study.
 Other: Descriptive study
More than 65 years old elders


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Dynamic balance [ Time Frame: baseline ]
    Dynamic balance is going to be measured using the Mini-Best test. This is a 14-item test that focuses on dynamic balance, specifically anticipatory transitions, postural responses, sensory orientation, and dynamic gait


Secondary Outcome Measures :
  1. Cognitive impairment [ Time Frame: baseline ]
    The cognitive impairment will be measured using the Montreal Cognitive Assessment and the Mini-Mental State Examination. The Montreal Cognitive Assessment is a test designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The Mini Mental State Examination is a 10-minute bedside measure of impaired thinking in undeveloped, uneducated, diseased, or very old populations.

  2. Attention [ Time Frame: baseline ]
    Attention is going to be measured with the Stroop test.

  3. Cognitive flexibility [ Time Frame: baseline ]
    The cognitive flexibility of patients is measured using the Trial Making Test. This test explores visual-conceptual and visual-motor tracking, and it is a frequently used neuropsychological test.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Elders
Criteria

Inclusion Criteria:

  • Nursing home residents.

Exclusion Criteria:

  • Surgery on lower limbs.
  • Traumatic damage on lower limbs.
  • Severe cognitive impairment in order not to complete the assessment.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051270


Locations
Layout table for location information
Spain
Faculty of health Sciences. University of Granada
Granada, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
Investigators
Layout table for investigator information
Principal Investigator: Marie Carmen Valenza, PhD Universidad de Granada
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Marie Carmen Valenza, assistant professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT02051270    
Other Study ID Numbers: DF0050UG
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Keywords provided by Marie Carmen Valenza, Universidad de Granada:
Elderly
Nursing homes
Mild cognitive impairment
Additional relevant MeSH terms:
Layout table for MeSH terms
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders