NCT01585337

Brief Summary

The hypotheses of this study are as follows:

  1. 1.There is no significant muscle activity difference of each muscle in patients between pre and post operation.
  2. 2.There is no significant forward reach distance/average velocity difference in patients between pre and post operation.
  3. 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. 4.There is no significant muscle activity difference between muscles on both sides at post operation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 8, 2015

Status Verified

July 1, 2015

Enrollment Period

4.1 years

First QC Date

April 23, 2012

Last Update Submit

July 7, 2015

Conditions

Fusion of Spine, Lumbar Region

Outcome Measures

Primary Outcomes (1)

  • EMG

    one months post operation

Secondary Outcomes (1)

  • forward reach distance

    one month post operation

Study Arms (1)

patients with lumbar fusion

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • scoliosis;
  • neurological disorder;
  • Self-reported impairment in daily activities;
  • leg length deficiency over 2 cm;
  • body mass index over 30.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University, College of Medicine

Taipei, Taiwan

RECRUITING

Study Officials

  • Wei-Li Hsu, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Li Hsu, PhD

CONTACT

+8862-33668127wlhsu@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2012

First Posted

April 25, 2012

Study Start

January 1, 2012

Primary Completion

February 1, 2016

Study Completion

December 1, 2016

Last Updated

July 8, 2015

Record last verified: 2015-07

Locations

TW(1)