Trunk Forward Ability in Patients With Lumbar Fusion

Fusion of Spine, Lumbar Region Clinical Trial

Official title:

Joint Coordination Changes During Functional Activities After Lumbar Fusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01585337
• Other study ID #: 201109033RC
• Status: Recruiting
• Phase: N/A
• First received: April 23, 2012
• Last updated: July 7, 2015
• Start date: January 2012
• Est. completion date: December 2016

Study information

• Verified date: July 2015
• Source: National Taiwan University Hospital
• Contact: Wei-Li Hsu, PhD
• Phone: +8862-33668127
• Email: wlhsu[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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:

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fusion of Spine, Lumbar Region

Locations

Country	Name	City	State
Taiwan	National Taiwan University, College of Medicine	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EMG		one months post operation	No
Secondary	forward reach distance		one month post operation	Yes