ScoliosisPhase 1NCT00154505
Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons
A Phase 1 study testing Lateral trunk support of wheelchair seating in people with Scoliosis and Spinal Cord Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The effects of lateral trunk supports (LTS) in special seating on the spinal alignment of 17 spinal cord injured (SCI) subjects with scoliosis were studied using bi-planar radiographs. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Scoliosis, Spinal Cord Injury
- What is being tested?
- Lateral trunk support of wheelchair seating
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2002to Nov 2004
- Phase
- Phase 1
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (1) C4-T12 SCI, (2) onset over 1 year, (3) sitting on the wheelchair more than 4 hours per day, (4) diagnosed thoracic or lumbar scoliosis through A-P radiographs, (5) flexible scoliosis, confirmed by supine and side-lying bending radiographs.
Who cannot join
- inflexible scoliosis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School of Occupational Therapy, National Taiwan University
Taipei, 100
About this study
The effects of lateral trunk supports (LTS) in special seating on the spinal alignment of 17 spinal cord injured (SCI) subjects with scoliosis were studied using bi-planar radiographs. The LTS improved significantly the functional scoliotic spinal alignment in the frontal and sagittal planes regardless of the severity of scoliosis.
Read the detailed description
SCI patients often develop progressive scoliosis due to loss of muscular support to maintain good sitting posture. Special seating with LTS has been widely used in clinical practice to improve their sitting postures. However, little is known as to how this can affect the scoliotic curve.The purpose of this study was to investigate the effects of lateral trunk supports (LTS) in special seating on the spinal alignment of spinal cord injured (SCI) individuals with scoliosis.
Ten male and seven female SCI subjects with scoliosis sat on an experimental chair with and without LTS while radiographs of the spine in the anteroposterior and lateral directions were taken. Radiographs of the spine in the A-P and lateral directions were taken with a digital radiographic imaging system (Saturn 9000 M, Comed., Korea). For each direction, the complete image of the spine was obtained from separate x-ray images of the upper and lower trunk due to the limited field of view of the x-ray machine. The Cobb angles and scoliotic indices based on the anteroposterior radiographic images and the angles of the thoracic and lumber spine based on lateral were calculated.
- Conditions
- Scoliosis, Spinal Cord Injury
- Being tested
- Lateral trunk support of wheelchair seating
- Keywords
- Scoliosis, Spinal Cord Injury, Lateral Trunk Support, Radiography
- Medical subject headings
- Scoliosis, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral trunk support of wheelchair seatingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal aligamnet(Cobb angle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2002
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Hui-Fen Mao, MS, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154505
- Sponsor's protocol ID
- 9261701245
- Other IDs
- NSC 91-2314-B-002-393, NSC 92-2314-B-002-084
- Status last verified
- Aug 2002
- First submitted
- 9 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons
- ClinicalTrials.gov ID
- NCT00154505
- Acronym / sponsor ID
- 9261701245
- Conditions
- Scoliosis, Spinal Cord Injury
- Keywords
- Scoliosis, Spinal Cord Injury, Lateral Trunk Support, Radiography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Sep 2002
- Study completion
- Nov 2004
- First posted
- 12 Sep 2005 (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 effects of lateral trunk supports (LTS) in special seating on the spinal alignment of 17 spinal cord injured (SCI) subjects with scoliosis were studied using bi-planar radiographs. The LTS improved significantly the functional scoliotic spinal alignment in the frontal and sagittal planes regardless of the severity of scoliosis.
Detailed description
SCI patients often develop progressive scoliosis due to loss of muscular support to maintain good sitting posture. Special seating with LTS has been widely used in clinical practice to improve their sitting postures. However, little is known as to how this can affect the scoliotic curve.The purpose of this study was to investigate the effects of lateral trunk supports (LTS) in special seating on the spinal alignment of spinal cord injured (SCI) individuals with scoliosis.
Ten male and seven female SCI subjects with scoliosis sat on an experimental chair with and without LTS while radiographs of the spine in the anteroposterior and lateral directions were taken. Radiographs of the spine in the A-P and lateral directions were taken with a digital radiographic imaging system (Saturn 9000 M, Comed., Korea). For each direction, the complete image of the spine was obtained from separate x-ray images of the upper and lower trunk due to the limited field of view of the x-ray machine. The Cobb angles and scoliotic indices based on the anteroposterior radiographic images and the angles of the thoracic and lumber spine based on lateral were calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (1) C4-T12 SCI, (2) onset over 1 year, (3) sitting on the wheelchair more than 4 hours per day, (4) diagnosed thoracic or lumbar scoliosis through A-P radiographs, (5) flexible scoliosis, confirmed by supine and side-lying bending radiographs.
Key exclusion criteria (1 listed)
- inflexible scoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateral trunk support of wheelchair seating | Device | – |
Primary outcome
Spinal aligamnet(Cobb angle)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2005.
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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.
Hui-Fen Mao, MS principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lateral trunk support of wheelchair seating in people with Scoliosis and Spinal Cord Injury, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Sep 2005. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal aligamnet(Cobb angle). 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 12 Sep 2005.