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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04135755
Other study ID # CF15027A
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 16, 2015
Est. completion date August 22, 2016

Study information

Verified date February 2015
Source Taichung Veterans General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date August 22, 2016
Est. primary completion date August 22, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 75 Years
Eligibility 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 Design


Intervention

Other:
no drug intervention
no drug or treatment intervention

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Taichung Veterans General Hospital Hungkuang University

References & Publications (1)

Lynn SG, Sinaki M, Westerlind KC. Balance characteristics of persons with osteoporosis. Arch Phys Med Rehabil. 1997 Mar;78(3):273-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postural Stability 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
Primary limits of stability 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
Primary Kinematic Data The movements of the head, upper spine, lower spine, pelvis,hip, thigh, and knee were measured using 6 inertial measurement units. 5 minutes
Primary timed up-and-go test sit-stand-walk-180° turning-walk and sitting down task 90 second
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