NCT01504230

Brief Summary

Osteoporosis is a prevalent health concern among older adults and is associated with an increased risk of falls that can cause fracture, injury and even mortality. Identifying the factors related to falls occur within this population is essential for the development of effective regimes for fall prevention. The long-term objectives of this work are to ascertain the mechanisms for effectively controlling balance in seniors with osteoporosis and to provide a basis for developing fall prevention programs. The entire body's center of mass (CoM) is a critical indicator for balance control and the coordination among joints and muscles to control the CoM is still unclear. The aim1 of this study is to develop biomechanical models that control the entire body's center of mass (CoM) during upright quiet stance in seniors with osteoporosis. The aim2 of this study is to identify the mechanism to control the entire body's CoM after receiving a balance perturbation in seniors with osteoporosis. The findings of this research can provide needed information regarding the processes of balance control in this vulnerable osteoporosis population, and has the potential to be applied to individuals with other neuromuscular and orthopedic deficits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2011

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

September 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

1.8 years

First QC Date

January 3, 2012

Last Update Submit

December 15, 2016

Conditions

Keywords

To ascertain the mechanisms for effectively controlling balance in seniors with osteoporosis and to provide a basis for developing fall prevention programs.To develop biomechanical models that control the entire body's center of mass (CoM) during upright quiet stance in seniors with osteoporosis.To identify the mechanism to control the entire body's CoM after receiving a balance perturbation in seniors with osteoporosis.

Study Arms (2)

health older adults

Osteoporosis participants

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

community sample

You may qualify if:

  • for healthy older adults (OA)
  • can stand for 5 minutes and walk for 6 minutes independently
  • normal or corrected to normal vision
  • an age between 65-85 years
  • no osteoporosis (T-score above -2.5)
  • for osteoporosis participants (OP)
  • can stand for 5 minutes and walk for 6 minutes independently
  • normal or corrected to normal vision
  • an age between 65-85 years
  • no osteoporosis (T-score below -2.5)

You may not qualify if:

  • pregnant women
  • cancer diagnosis
  • sensory-motor deficits
  • the BMI is larger than 30 or smaller than 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School & Graduate Institute of Physical Therapy College of Medicine, National Taiwan University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Wei-Li Hsu, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2012

First Posted

January 5, 2012

Study Start

September 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

December 16, 2016

Record last verified: 2016-12

Locations