ScoliosisNCT01109082
Gait and Postural Stability Assessment in Children With Idiopathic Scoliosis Undergoing Posterior Spine Instrumentation
An observational study of Scoliosis, run by Shriners Hospitals for Children at 1 site in United States.
Trial summary
The goal of this study is to evaluate children and adolescents with idiopathic scoliosis who are undergoing spinal fusion using motion analysis, balance, and outcome questionnaires. Read more about this study
- Who is it for?
- Ages 1 year to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis
- What is being tested?
- posterior spine fusion
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2012
- 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 1 year to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents with idiopathic scoliosis that have a Cobb angle greater than 50 degrees.
Who may be able to join
- idiopathic scoliosis
- between the ages of 10 - 20
- need a spine fusion at L4 or above
- can walk on your own
- have not had surgery on spine before
Who cannot join
- pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children
Chicago, Illinois, 60707
About this study
The goal of this study is to evaluate children and adolescents with idiopathic scoliosis who are undergoing spinal fusion using motion analysis, balance, and outcome questionnaires. Little research has been done to evaluate how different fusion levels impact walking patterns, range of motion, posture and balance following spine instrumentation in children with idiopathic scoliosis. Debate still continues whether posterior spinal instrumentation with the last instrumented vertebra at or above Lumbar 3 (L3) will provide sufficient spine correction, greater motion, and better posture and balance when compared to a child with instrumentation at Lumbar 4 (L4). Furthermore, how does the spine fusion endpoint (last instrumented vertebra) impact quality of life, participation, and impairment in children and adolescents with idiopathic scoliosis and how do they compare to healthy age-matched peers. The goal of this study is to compare these two end points using gait analysis, postural stability, and outcome tools with the hopes of providing better clinical care to children with idiopathic scoliosis.
Read the detailed description
The study population will include sixty (60) children with idiopathic scoliosis who will undergo spine surgery and sixty (60) developing children "Control Group". Scoliosis patients will undergo a period of testing which requires three visits: pre-operative evaluation, one-year post-operative evaluation, and two-year post-operative evaluation. The Control Group will require one initial assessment. A total of 240 evaluations will be performed over a three-year period. We will evaluate the correlation among outcome tools and quantitative measures in order to determine how these instruments can be used more effectively for better treatment. Subjects and their parents will be fully informed of the nature of the study as well as the potential risk involved and sign the appropriate consent form. The study will be reviewed by the IRB and include HIPAA compliance. This will be accomplished during testing at the Shriners Hospital for Children- Chicago Motion Analysis Lab. All possible steps will be taken to assure the safety and convenience of the study participants. All subjects will be evaluated using clinical outcome tools (PODCI, SF-36) and will undergo quantitative 3-D motion analysis and postural stability assessment. Quantitative 3-D gait analysis will be done with our 14-camera Motion Capture system and passive reflective markers (Figure 3). Motion analysis will be performed with each subject walking at a comfortable and natural speed on the laboratory walkway. Passive markers will be attached to anatomic landmarks in standardized locations using double-backed tape. Marker coordinate data will be used to determine range of motion and joint angles.
Four forceplates will be used to measure kinetic data and static balance. Postural stability testing will be performed on all subjects (Figure 4). We will evaluate responses to dynamic stability challenges that investigates motor and sensory control and adaptation to perturbations. Static (quiet standing) postural stability tests will be done on all subjects. A licensed physical therapist (PT) will perform the exam following the protocol of the Shriners Hospital for Children's motion lab.
- Conditions
- Scoliosis
- Being tested
- posterior spine fusion
- Keywords
- Scoliosis, gait, posture, balance
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior spine fusionProcedure or surgery
vertebrae are fused to straighten a spinal curve
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with idiopathic scoliosis | Adolescents with idiopathic scoliosis Receives: Procedure: posterior spine fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motion Analysis
Gait and standing spine range of motion are measured using a 3-D motion capture system.
Measured: Pre-Operation visit (within 1 week prior to surgical date)
Motion Analysis
Gait and standing spine range of motion are measured using a 3-D motion capture system.
Measured: 1 Year Post-Operative
Motion Analysis
Gait and standing spine range of motion are measured using a 3-D motion capture system.
Measured: 2 Years Post-Operative
Secondary outcomes (9)
Functional Questionnaires
A functional outcome questionnaire filled out by the parents and patient.
Measured: Collected at Pre-Operative visit (1 week prior to surgical date)
Functional Questionnaires
A functional outcome questionnaire filled out by the parents and patient.
Measured: Collected at 1 year post-operative visit
e-med plantar pressures
A pressure map of the plantar surface of the foot during walking.
Measured: Collected at Pre-Operative visit (1 week prior to surgical visit)
Postural Stability
Standing balance and postural stability are measured using a NeuroCom Equitest System and Twin Forceplate system.
Measured: Pre-Operative (1 week prior to surgical visit)
Functional Questionnaires
A functional outcome questionnaire filled out by the parents and patient.
Measured: Collected at 2 year follow up
e-med plantar pressures
A pressure map of the plantar surface of the foot during walking.
Measured: Collected at 1 year follow up
e-med plantar pressure
A pressure map of the plantar surface of the foot during walking.
Measured: 2 year follow up
Postural Stability
Standing balance and postural stability are measured using a NeuroCom Equitest System and Twin Forceplate system.
Measured: 1 Year post-operative visit
Postural Stability
Standing balance and postural stability are measured using a NeuroCom Equitest System and Twin Forceplate system.
Measured: 2 year post-operative follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startDec 2007
- Primary completionDec 2012
- Study completionDec 2012
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Spine
- Responsible party
- Principal investigator, Sahar Hassani, Shriners Hospitals for Children
- Investigators
- Sahar Hassani, MS, Principal investigator, Shriners Hosptials for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109082
- Sponsor's protocol ID
- AIS-2010
- Status last verified
- Mar 2013
- First submitted
- 15 Apr 2010
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait and Postural Stability Assessment in Children With Idiopathic Scoliosis Undergoing Posterior Spine Instrumentation
- ClinicalTrials.gov ID
- NCT01109082
- Acronym / sponsor ID
- AIS-2010
- Conditions
- Scoliosis
- Keywords
- Scoliosis, gait, posture, balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Collaborators
- DePuy Spine
- Study start
- Dec 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Apr 2010 (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 goal of this study is to evaluate children and adolescents with idiopathic scoliosis who are undergoing spinal fusion using motion analysis, balance, and outcome questionnaires. Little research has been done to evaluate how different fusion levels impact walking patterns, range of motion, posture and balance following spine instrumentation in children with idiopathic scoliosis. Debate still continues whether posterior spinal instrumentation with the last instrumented vertebra at or above Lumbar 3 (L3) will provide sufficient spine correction, greater motion, and better posture and balance when compared to a child with instrumentation at Lumbar 4 (L4). Furthermore, how does the spine fusion endpoint (last instrumented vertebra) impact quality of life, participation, and impairment in children and adolescents with idiopathic scoliosis and how do they compare to healthy age-matched peers. The goal of this study is to compare these two end points using gait analysis, postural stability, and outcome tools with the hopes of providing better clinical care to children with idiopathic scoliosis.
Detailed description
The study population will include sixty (60) children with idiopathic scoliosis who will undergo spine surgery and sixty (60) developing children "Control Group". Scoliosis patients will undergo a period of testing which requires three visits: pre-operative evaluation, one-year post-operative evaluation, and two-year post-operative evaluation. The Control Group will require one initial assessment. A total of 240 evaluations will be performed over a three-year period. We will evaluate the correlation among outcome tools and quantitative measures in order to determine how these instruments can be used more effectively for better treatment. Subjects and their parents will be fully informed of the nature of the study as well as the potential risk involved and sign the appropriate consent form. The study will be reviewed by the IRB and include HIPAA compliance. This will be accomplished during testing at the Shriners Hospital for Children- Chicago Motion Analysis Lab. All possible steps will be taken to assure the safety and convenience of the study participants. All subjects will be evaluated using clinical outcome tools (PODCI, SF-36) and will undergo quantitative 3-D motion analysis and postural stability assessment. Quantitative 3-D gait analysis will be done with our 14-camera Motion Capture system and passive reflective markers (Figure 3). Motion analysis will be performed with each subject walking at a comfortable and natural speed on the laboratory walkway. Passive markers will be attached to anatomic landmarks in standardized locations using double-backed tape. Marker coordinate data will be used to determine range of motion and joint angles.
Four forceplates will be used to measure kinetic data and static balance. Postural stability testing will be performed on all subjects (Figure 4). We will evaluate responses to dynamic stability challenges that investigates motor and sensory control and adaptation to perturbations. Static (quiet standing) postural stability tests will be done on all subjects. A licensed physical therapist (PT) will perform the exam following the protocol of the Shriners Hospital for Children's motion lab.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents with idiopathic scoliosis | – | Procedure: posterior spine fusionAdolescents with idiopathic scoliosis |
Who may qualify
- Ages
- 1 year to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with idiopathic scoliosis that have a Cobb angle greater than 50 degrees.
Key inclusion criteria (5 listed)
- idiopathic scoliosis
- between the ages of 10 - 20
- need a spine fusion at L4 or above
- can walk on your own
- have not had surgery on spine before
Key exclusion criteria (1 listed)
- pregnant
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 |
|---|---|---|
| posterior spine fusionvertebrae are fused to straighten a spinal curve | Procedure or surgery | Adolescents with idiopathic scoliosis |
Primary outcome
Motion Analysis
Time frame: Pre-Operation visit (within 1 week prior to surgical date)
Gait and standing spine range of motion are measured using a 3-D motion capture system.
Motion Analysis
Time frame: 1 Year Post-Operative
Gait and standing spine range of motion are measured using a 3-D motion capture system.
Motion Analysis
Time frame: 2 Years Post-Operative
Gait and standing spine range of motion are measured using a 3-D motion capture system.
9 secondary outcomes
Functional Questionnaires
Time frame: Collected at Pre-Operative visit (1 week prior to surgical date)
Functional Questionnaires
Time frame: Collected at 1 year post-operative visit
e-med plantar pressures
Time frame: Collected at Pre-Operative visit (1 week prior to surgical visit)
Postural Stability
Time frame: Pre-Operative (1 week prior to surgical visit)
Functional Questionnaires
Time frame: Collected at 2 year follow up
e-med plantar pressures
Time frame: Collected at 1 year follow up
e-med plantar pressure
Time frame: 2 year follow up
Postural Stability
Time frame: 1 Year post-operative visit
Postural Stability
Time frame: 2 year post-operative follow up
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 19 Mar 2013.
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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.
Sahar Hassani, MS principal investigator
Shriners Hosptials for Children
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 Scoliosis, run by Shriners Hospitals for Children at 1 site in United States.
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 5 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 19 Mar 2013. 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 United States. 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?
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?
Motion Analysis (time frame: Pre-Operation visit (within 1 week prior to surgical date)). The study lists 3 primary outcomes in all. 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 19 Mar 2013.