NCT02051270

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

January 27, 2014

Last Update Submit

November 1, 2016

Conditions

Mild Cognitive Impairment

Keywords

ElderlyNursing homesMild cognitive impairment

Outcome Measures

Primary Outcomes (1)

  • Dynamic balance

    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

    baseline

Secondary Outcomes (3)

  • Cognitive impairment

    baseline

  • Attention

    baseline

  • Cognitive flexibility

    baseline

Study Arms (1)

Elders

Older people living in nursing homes will undergo a descriptive study.

Other: Descriptive study

Interventions

Descriptive studyOTHER

More than 65 years old elders

Elders

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elders

You may qualify if:

  • Nursing home residents.

You may not qualify if:

  • Surgery on lower limbs.
  • Traumatic damage on lower limbs.
  • Severe cognitive impairment in order not to complete the assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of health Sciences. University of Granada

Granada, Spain, 18071, Spain

Location

Related Publications (1)

  • Diaz-Pelegrina A, Cabrera-Martos I, Lopez-Torres I, Rodriguez-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.

    PMID: 26541310BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Marie Carmen Valenza, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 27, 2014

First Posted

January 31, 2014

Study Start

January 1, 2014

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

ES(1)