The Spine Kinematics and Center of Pressure Excursion During Functional Task Vertebral Compression Fractures Subjects

November 2, 2019 updated by: Taichung Veterans General Hospital

The Spine Kinematics and Center of Pressure Excursion During Functional Task in Scoliosis and Vertebral Compression Fractures Subjects

This study aimed to assess the sensory and kinematic components of the limits of stability (LOS) test in patients with vertebral compression fracture (VCF) .

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

This study enrolled adults with VCF (VCF group), older adult without spinal deformity (NE group), and young adults (NY group). The Biodex balance system was employed to calculate the balance score and the LOS of participants. An inertia motion system was used to record kinematic data. The center of pressure (COP) signals of postural stability and LOS were used to calculate the frequency power spectrum for interpreting the sensory component.

Study Type

Observational

Enrollment (Actual)

46

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study enrolled 13 adults with VCF, 13 older adult without spinal deformity, and 13 young adults.

Description

Vertebral compression fracture Inclusion Criteria:

older than 65 years osteoporosis diagnosed by a bone mineral density test of the lumbar spine (T-score < -2.5; T: peak bone mass) thoracic-lumbar VCF on radiography without displacement

Vertebral compression fracture Exclusion Criteria:

other spinal diseases that might also cause back pain (such as scoliosis, lumbar spondylolisthesis, lumbar disk disease, and spinal stenosis) a history of diabetes a history of neurological disease (such as cerebral vascular disease, peripheral neuropathy and vestibular disease).

Control Inclusion Criteria:

None the control participants had evidence of gait, postural, or spine disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
vertebral compression fracture
No drugs intervention
no drug or treatment intervention
older adult without spinal deformity
No drugs intervention
no drug or treatment intervention
young adults
No drugs intervention
no drug or treatment intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postural Stability
Time Frame: 90 second
A balance system was employed to calculate the standing posture sway score.A high score was indicative of excessive movement during the test and thus, poor stability. The range of value was 0.3- 4.1.
90 second
limits of stability
Time Frame: 1-2 minutes
patients shift their center of gravity from the center target to a blinking target and back to the center target.This process was repeated for each of the 9 targets. A high score was indicative of fine direction control.The range of value was 21- 66.
1-2 minutes
Kinematic Data
Time Frame: 5 minutes
The movements of the head, upper spine, lower spine, pelvis,hip, thigh, and knee were measured using 6 inertial measurement units.
5 minutes
timed up-and-go test
Time Frame: 90 second
sit-stand-walk-180° turning-walk and sitting down task
90 second

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Shin-Tsu Chang, phD, Taichung Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2015

Primary Completion (Actual)

August 22, 2016

Study Completion (Actual)

August 22, 2016

Study Registration Dates

First Submitted

October 20, 2019

First Submitted That Met QC Criteria

October 20, 2019

First Posted (Actual)

October 23, 2019

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 2, 2019

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • CF15027A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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