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

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ClinicalTrials.gov Identifier: NCT04135755
Recruitment Status : Completed
First Posted : October 23, 2019
Last Update Posted : November 5, 2019
Sponsor:
Collaborator:
Hungkuang University
Information provided by (Responsible Party):
Taichung Veterans General Hospital

Brief 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) .

Condition or disease Intervention/treatment
Posture Vertebral Compression Fracture Other: no drug intervention

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.

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Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Spine Kinematics and Center of Pressure Excursion During Functional Task in Scoliosis and Vertebral Compression Fractures Subjects
Actual Study Start Date : March 16, 2015
Actual Primary Completion Date : August 22, 2016
Actual Study Completion Date : August 22, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort Intervention/treatment
vertebral compression fracture
No drugs intervention
Other: no drug intervention
no drug or treatment intervention

older adult without spinal deformity
No drugs intervention
Other: no drug intervention
no drug or treatment intervention

young adults
No drugs intervention
Other: no drug intervention
no drug or treatment intervention




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. timed up-and-go test [ Time Frame: 90 second ]
    sit-stand-walk-180° turning-walk and sitting down task



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study enrolled 13 adults with VCF, 13 older adult without spinal deformity, and 13 young adults.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135755


Sponsors and Collaborators
Taichung Veterans General Hospital
Hungkuang University
Investigators
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Principal Investigator: Shin-Tsu Chang, phD Taichung Veterans General Hospital
Publications:
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Responsible Party: Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT04135755    
Other Study ID Numbers: CF15027A
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: February 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Compression
Wounds and Injuries