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Analysis of Balance in the Aging Process

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ClinicalTrials.gov Identifier: NCT00906711
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : May 21, 2009
Sponsor:
Information provided by:
Universidade de Franca

Tracking Information
First Submitted Date May 19, 2009
First Posted Date May 21, 2009
Last Update Posted Date May 21, 2009
Study Start Date February 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Analysis of Balance in the Aging Process
Official Title Analysis of Balance in the Aging Process
Brief Summary

Introduction: While growing older, it is possible to notice a decrease in the functional and physiological reserves in the organism which impairs the the abilities in the elderly in doing some tasks. A simple balance becomes a challenge.

Objective: To evaluate the functional balance in the aging process.

Methods: The group was formed by 48 people from 10 to 85 years old. The evaluation instruments are the Berg Balance Scale (BBS), the Performance Oriented Mobility Assessment (POMA), the Unipodal Support Test, the Functional Reach Test and the Romberg's Test.

Detailed Description

48 individuals of both sexes and aged between 10 and 85 years were chosen. These individuals were divided according to age, into four groups (each group containing 12 individuals, 6 men and 6 women): Group I (G1): 10 - 18, Group II (G2): 20 - 35; Group III (G3): 45 - 60, Group IV (G4): 65 - 85.

The instruments used for assessment of the balance were: (1) Berg Scale - consists of 14 items with common activities of daily life, with progressive degree of difficulty (2) Assessment of Gait and Balance for Performance Oriented (POMA), consists of a protocol that evaluates the static and dynamic balance, with operations similar to the activities of daily living, (3) Test Support Unipodal; (4) adapted Functional Reach Test, which assesses the stability in the standing position, (5) Test and Romberg Romberg's test Romberg-Barré or sensitized conducted in stable and unstable soil, and all positions were first with open eyes and then with closed eyes. The duration of each exposure was 30 seconds, with different positioning of the feet.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen The evaluation instruments are the Berg Balance Scale (BBS), the Performance Oriented Mobility Assessment (POMA), the Unipodal Support Test, the Functional Reach Test and the Romberg's Test.
Sampling Method Non-Probability Sample
Study Population The participants were selected in dependency of Unifran (University of France) and the homes of the neighborhood. The choice of groups was based according to the degree of functionality and independence in order to analyze the lack of balance in the process of aging.
Condition Aging
Intervention Not Provided
Study Groups/Cohorts
  • Group I
    (G1): 10 - 18 years old
  • Group II
    (G2): 20 - 35 years old
  • Group III
    (G3): 45 - 60 years old
  • Group IV
    (G4): 65 - 85 years old
Publications * Not Provided

*   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: May 20, 2009)
48
Original Actual Enrollment Same as current
Actual Study Completion Date October 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Absence of the basic pathology that interferes directly in the balance

Exclusion Criteria:

  • Neurological changes
  • Cognitive impairment
  • Orthopedic injury
  • Use of orthoses for lower limb
  • Obesity
  • Exercise frequently (more than twice a week)
  • The bearer of any commitment to stay in their standing position
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years to 85 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00906711
Other Study ID Numbers 0081/08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lislei Jorge Patrizzi, Universidade de Franca
Study Sponsor Universidade de Franca
Collaborators Not Provided
Investigators
Study Director: Lislei Patrizzi Universidade de Franca
PRS Account Universidade de Franca
Verification Date May 2009