- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04135755
The Spine Kinematics and Center of Pressure Excursion During Functional Task Vertebral Compression Fractures Subjects
The Spine Kinematics and Center of Pressure Excursion During Functional Task in Scoliosis and Vertebral Compression Fractures Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Collaborators
Investigators
- Principal Investigator: Shin-Tsu Chang, phD, Taichung Veterans General Hospital
Publications and helpful links
General Publications
- Lynn SG, Sinaki M, Westerlind KC. Balance characteristics of persons with osteoporosis. Arch Phys Med Rehabil. 1997 Mar;78(3):273-7. doi: 10.1016/s0003-9993(97)90033-2.
- Kuo FC, Chang ST, Liao YY, Lee CH. Center of Pressure Trace and Sensory Components of the Limits of Stability Test in Older Adults With Vertebral Compression Fractures. J Geriatr Phys Ther. 2020 Jan/Mar;43(1):24-31. doi: 10.1519/JPT.0000000000000201.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CF15027A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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