Trunk Forward Ability in Patients With Lumbar Fusion

Joint Coordination Changes During Functional Activities After Lumbar Fusion

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.

Study Overview

• Status: Unknown
• Conditions: Fusion of Spine, Lumbar Region

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University, College of Medicine
    • Contact: Wei-Li Hsu, PhD; Phone Number: +8862-33668127; Email: wlhsu@ntu.edu.tw
    • Principal Investigator: Jwo-Luen Pao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
patients with lumbar fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
EMG	one months post operation

Secondary Outcome Measures

Outcome Measure	Time Frame
forward reach distance	one month post operation

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Wei-Li Hsu, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: April 23, 2012
• First Submitted That Met QC Criteria: April 23, 2012
• First Posted (Estimate): April 25, 2012

Study Record Updates

• Last Update Posted (Estimate): July 8, 2015
• Last Update Submitted That Met QC Criteria: July 7, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 201109033RC