Trunk Forward Ability in Patients With Lumbar Fusion

NCT ID: NCT01585337

Last Updated: 2015-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fusion of Spine, Lumbar Region

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with lumbar fusion

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei-Li Hsu, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University, College of Medicine

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Wei-Li Hsu, PhD

Role: CONTACT

+8862-33668127

Facility Contacts

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Wei-Li Hsu, PhD

Role: primary

+8862-33668127

Other Identifiers

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201109033RC

Identifier Type: -

Identifier Source: org_study_id

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