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Status unknownNCT01585337Updated Jul 8, 2015

Trunk Forward Ability in Patients With Lumbar Fusion

An observational study in Fusion of Spine, Lumbar Region, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-07-08.

Sponsored by National Taiwan University Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
30 Years to 80 Years
Sex
All
01

Study summary

The hypotheses of this study are as follows:

  1. There is no significant muscle activity difference of each muscle in patients between pre and post operation.
  2. There is no significant forward reach distance/average velocity difference in patients between pre and post operation.
  3. There is no significant standard deviation of center of pressure (COP) along x axis, speed of COP along y axis during the task and COP path during the 3-sec holding phase difference in patients between pre and post operation.
  4. There is no significant muscle activity difference between muscles on both sides at post operation.
Read the detailed description

30 healthy adults and 30 patients is going to undergo lumbar fusion surgery will be recruited in this study. The assessment will be held before surgery, two months, three months and six months after surgery. Visual pain scale and passive range of motion over lumbar, hip, knee, ankle joint of each subjects will be recorded. Then the maximum voluntary contraction at lower extremity will be measured by electromyography. Finally, the subjects will be asked to do forward reach by dominant upper limb/bilateral upper limbs/arm crossed in the front of chest for three times in standing and sitting position after five practices. The motion data will be collected by 3-dimension video and the muscle activity by electromyography.

02

Conditions studied

  • Fusion of Spine, Lumbar Region
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

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

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All subjects will be recruited from Far Eastern Memorial Hospital. The study is approved by the Institutional Medical Research Ethics Committees in both National Taiwan University Hospital and Far Eastern Memorial Hospital. The consent form is as . We will recruit patients aged between 30 to 60 years old.

Inclusion criteria

  1. specific low back pain with MRI finding by the radiologist and the surgeon;
  2. patient who is scheduled for MISS in one week.

Exclusion criteria

Exclusion Criteria:

  1. scoliosis;
  2. neurological disorder;
  3. Self-reported impairment in daily activities;
  4. leg length deficiency over 2 cm;
  5. body mass index over 30.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients with lumbar fusion
06

What researchers measure

Primary outcomes

  1. EMG

    Time frame: one months post operation

Secondary outcomes

  1. forward reach distance

    Time frame: one month post operation

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University, College of Medicine
    Taipei, Taiwan
    • Wei-Li Hsu, PhD · Contact · wlhsu@ntu.edu.tw · +8862-33668127
    • Jwo-Luen Pao, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01585337
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Apr 25, 2012
Start date
Jan 2012
Primary completion
Feb 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Jul 8, 2015

Study contacts

Wei-Li Hsu, PhD
Contact
wlhsu@ntu.edu.tw
+8862-33668127
Wei-Li Hsu, PhD
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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