NCT00906711

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2008

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
Last Updated

May 21, 2009

Status Verified

May 1, 2009

Enrollment Period

6 months

First QC Date

May 19, 2009

Last Update Submit

May 20, 2009

Conditions

Aging

Keywords

AgingPostural Balance

Study Arms (4)

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

Eligibility Criteria

Age10 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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.

Study Officials

  • Lislei Patrizzi

    Universidade de Franca

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 21, 2009

Study Start

February 1, 2008

Primary Completion

August 1, 2008

Study Completion

October 1, 2008

Last Updated

May 21, 2009

Record last verified: 2009-05