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Completed

NCT Number: NCT04135755

The Spine Kinematics and Center of Pressure Excursion During Functional Task 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) .

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

no drug intervention

Other

no drug or treatment intervention

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Collaborators

  • Hungkuang University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 23, 2019
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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