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

NCT04135755 | Completed

• 1 other identifier: CF15027A
• Study Type: observational
• Target: 46
• Locations: 0 countries
• Sites: N/A

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) .

Conditions

Posture; Vertebral Compression Fracture

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• timed up-and-go test

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

  90 second

Study Arms (3)

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

no drug intervention OTHER

no drug or treatment intervention

older adult without spinal deformity; vertebral compression fracture; young adults

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study enrolled 13 adults with VCF, 13 older adult without spinal deformity, and 13 young adults.

You may qualify if:

• 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

You may not qualify if:

• 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).
• None the control participants had evidence of gait, postural, or spine disorders.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead
• Hungkuang University: collaborator

Related Publications (2)

• 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.

  PMID: 9084349 BACKGROUND

• 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.

  PMID: 29923897 DERIVED

Study Officials

• Shin-Tsu Chang, phD

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: October 23, 2019
• Study Start: March 16, 2015
• Primary Completion: August 22, 2016
• Study Completion: August 22, 2016
• Last Updated: November 5, 2019

Record last verified: 2015-02

Data Sharing

• IPD Sharing: Will not share