Fusion of Spine, Lumbar RegionNCT01585337
Trunk Forward Ability in Patients With Lumbar Fusion
An observational study of Fusion of Spine, Lumbar Region, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Fusion of Spine, Lumbar Region
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2012to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- specific low back pain with MRI finding by the radiologist and the surgeon;
- patient who is scheduled for MISS in one week.
Who cannot join
- scoliosis;
- neurological disorder;
- Self-reported impairment in daily activities;
- leg length deficiency over 2 cm;
- body mass index over 30.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University, College of Medicine
Taipei
Wei-Li Hsu, PhD, +8862-33668127, wlhsu@ntu.edu.tw
Jwo-Luen Pao, MD
About this study
Official title: Joint Coordination Changes During Functional Activities After Lumbar Fusion
The hypotheses of this study are as follows:
- There is no significant muscle activity difference of each muscle in patients between pre and post operation.
- There is no significant forward reach distance/average velocity difference in patients between pre and post operation.
- 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.
- 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.
- Conditions
- Fusion of Spine, Lumbar Region
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with lumbar fusion | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG
Measured: one months post operation
Secondary outcomes (1)
forward reach distance
Measured: one month post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fusion of Spine, Lumbar RegionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Li Hsu, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585337
- Sponsor's protocol ID
- 201109033RC
- Status last verified
- Jul 2015
- First submitted
- 23 Apr 2012
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Coordination Changes During Functional Activities After Lumbar Fusion
- ClinicalTrials.gov ID
- NCT01585337
- Acronym / sponsor ID
- 201109033RC
- Conditions
- Fusion of Spine, Lumbar Region
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypotheses of this study are as follows:
- There is no significant muscle activity difference of each muscle in patients between pre and post operation.
- There is no significant forward reach distance/average velocity difference in patients between pre and post operation.
- 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.
- There is no significant muscle activity difference between muscles on both sides at post operation.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with lumbar fusion | – | – |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- specific low back pain with MRI finding by the radiologist and the surgeon;
- patient who is scheduled for MISS in one week.
Key exclusion criteria (5 listed)
- scoliosis;
- neurological disorder;
- Self-reported impairment in daily activities;
- leg length deficiency over 2 cm;
- body mass index over 30.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EMG
Time frame: one months post operation
1 secondary outcome
forward reach distance
Time frame: one month post operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Li Hsu, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fusion of Spine, Lumbar Region, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Li Hsu, PhD (+8862-33668127, wlhsu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMG (time frame: one months post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2015.