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CompletedNCT04135755Updated Nov 5, 2019

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

An observational study in Posture and Vertebral Compression Fracture, sponsored by Taichung Veterans General Hospital. Completed. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-05.

Sponsored by Taichung Veterans General Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
46
Ages
20 Years to 75 Years
Sex
All
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Study 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) .

Read the 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.

02

Conditions studied

  • Posture
  • Vertebral Compression Fracture

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03

In context

Fractures, Compression

50 studies on the registry are indexed under Fractures, Compression; 10 are open to participants now.

This study's enrollment of 46 is below the median of 100 across 16 observational studies indexed under Fractures, Compression.

Browse Fractures, Compression studies →

Lead sponsor

Taichung Veterans General Hospital is the lead sponsor of 175 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
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.

Eligibility 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.

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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
46 participants (actual)
Patient registry
No

Groups and cohorts

  • vertebral compression fracture

    No drugs intervention

    Other: no drug intervention

  • older adult without spinal deformity

    No drugs intervention

    Other: no drug intervention

  • young adults

    No drugs intervention

    Other: no drug intervention

Interventions

  • Otherno drug intervention

    no drug or treatment intervention

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 90 second

  2. 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.

    Time frame: 1-2 minutes

  3. Kinematic Data

    The movements of the head, upper spine, lower spine, pelvis,hip, thigh, and knee were measured using 6 inertial measurement units.

    Time frame: 5 minutes

  4. timed up-and-go test

    sit-stand-walk-180° turning-walk and sitting down task

    Time frame: 90 second

07

Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 9084349 ↗
  • 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. PubMed 29923897 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2015 to primary completion in Aug 2016, 17 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2019
First posted
Oct 23, 2019
StartActual
Mar 16, 2015
Primary completionActual
Aug 22, 2016
CompletionActual
Aug 22, 2016
Last update
Nov 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04135755
Collaborators
Hungkuang University
Responsible party
Sponsor
First posted
Oct 23, 2019
Start date
Mar 16, 2015
Primary completion
Aug 22, 2016
Completion
Aug 22, 2016
Last update
Nov 5, 2019

Study contacts

Shin-Tsu Chang, phD
principal investigator · Taichung Veterans General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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