We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
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

Tracking Information
First Submitted Date January 27, 2014
First Posted Date January 31, 2014
Last Update Posted Date November 2, 2016
Study Start Date January 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 29, 2014)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 29, 2014)
  • 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.
  • Attention [ Time Frame: baseline ]
    Attention is going to be measured with the Stroop test.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cognitive Impairment and Balance in Elderly
Official Title Mild Cognitive Impairment and Balance in Elderly
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Elders
Condition Mild Cognitive Impairment
Intervention Other: Descriptive study
More than 65 years old elders
Study Groups/Cohorts Elders
Older people living in nursing homes will undergo a descriptive study.
Intervention: Other: Descriptive study
Publications * Díaz-Pelegrina A, Cabrera-Martos I, López-Torres I, Rodríguez-Torres J, Valenza MC. [Effects of cognitive state on balance disturbances and gait disorders in institutionalised elderly]. Rev Esp Geriatr Gerontol. 2016 Mar-Apr;51(2):88-91. doi: 10.1016/j.regg.2015.07.014. Epub 2015 Nov 2. Spanish.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 1, 2016)
82
Original Estimated Enrollment
 (submitted: January 29, 2014)
100
Actual Study Completion Date May 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02051270
Other Study ID Numbers DF0050UG
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Marie Carmen Valenza, Universidad de Granada
Original Responsible Party Same as current
Current Study Sponsor Universidad de Granada
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Marie Carmen Valenza, PhD Universidad de Granada
PRS Account Universidad de Granada
Verification Date November 2016