Adolescent Idiopathic ScoliosisNCT02237248
Function and Scoliosis Surgery
An observational study of Adolescent Idiopathic Scoliosis, run by Duke University at 1 site in United States.
Trial summary
The purpose of the study is to examine the changes in function and performance biomechanics in patients undergoing spinal fusion corrective surgery for adolescent idiopathic scoliosis (AIS). Read more about this study
- Who is it for?
- Ages 12 to 18 years, women only
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 19 Jun 2017
- 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 12 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Patients that are undergoing spinal fusion surgery to treat idiopathic scoliosis.
Who may be able to join
- Clinical diagnosis of idiopathic scoliosis
- Patients identified to undergo spinal fusion surgery
- Treated at Duke University Medical Center
Who cannot join
- Neuromuscular or congenital scoliosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Functional Testing, and Biomechanics Before and After Scoliosis Surgery
The purpose of the study is to examine the changes in function and performance biomechanics in patients undergoing spinal fusion corrective surgery for adolescent idiopathic scoliosis (AIS).
Read the detailed description
Methods will consist of movement studies, questionnaires, and chart review. The recruited subjects will be followed at the usual clinical schedule of pre-op, 6-week, 3 -, 6- and 12-month post-operative follow-up visits. After signing informed consent, age at time of surgery, height, weight, body composition, leg length will be recorded to be used during data processing. Chart review will further yield data on Cobb angle, Lenke Scoliosis classification, instrumentation used during surgery, and level of spinal fusion. All subjects will be asked to complete assessments of activity level (Marx Score, Tegner Activity Score), general health (EQ-5D), and a validated scoliosis survey (Scoliosis Research Study questionnaire SRS-22). Movement studies will consist of the Lower Quarter Y Balance Test (YBT-LQ), and Functional Movement Screen (FMS), and measures of forward flexion, right and left lateral bending, and right and left trunk rotation. These measures will be assessed preoperatively and at postoperative follow-up visits.
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent Idiopathic Scoliosis, Functional Movement Screen, Y Balance Test
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lower Quarter Y-Balance Test (YBT-LQ)
The YBT-LQ is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform.
Measured: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Change in Functional Movement Screen (FMS)
The FMS is a screening tool used to identify limitations or asymmetries in movement patterns by executing seven motions. Activities include a deep squat, lunges, hurdle steps, a push-up, straight-leg raises, shoulder mobility assessments, and rotary stability assessments.
Measured: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Secondary outcomes (4)
Change in Tegner Activity Scale
Measured: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Change in Marx Activity Scale
Measured: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Change in EQ-5D
Measured: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Change in SRS-22
Measured: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startNov 2014
- Primary completion19 Jun 2017
- Study completion19 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert K Lark, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237248
- Sponsor's protocol ID
- Pro00055257
- Status last verified
- Jun 2017
- First submitted
- 9 Sep 2014
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Testing, and Biomechanics Before and After Scoliosis Surgery
- ClinicalTrials.gov ID
- NCT02237248
- Acronym / sponsor ID
- Pro00055257
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent Idiopathic Scoliosis, Functional Movement Screen, Y Balance Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- 19 Jun 2017 (actual)
- Study completion
- 19 Jun 2017 (actual)
- First posted
- 11 Sep 2014 (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 purpose of the study is to examine the changes in function and performance biomechanics in patients undergoing spinal fusion corrective surgery for adolescent idiopathic scoliosis (AIS).
Detailed description
Methods will consist of movement studies, questionnaires, and chart review. The recruited subjects will be followed at the usual clinical schedule of pre-op, 6-week, 3 -, 6- and 12-month post-operative follow-up visits. After signing informed consent, age at time of surgery, height, weight, body composition, leg length will be recorded to be used during data processing. Chart review will further yield data on Cobb angle, Lenke Scoliosis classification, instrumentation used during surgery, and level of spinal fusion. All subjects will be asked to complete assessments of activity level (Marx Score, Tegner Activity Score), general health (EQ-5D), and a validated scoliosis survey (Scoliosis Research Study questionnaire SRS-22). Movement studies will consist of the Lower Quarter Y Balance Test (YBT-LQ), and Functional Movement Screen (FMS), and measures of forward flexion, right and left lateral bending, and right and left trunk rotation. These measures will be assessed preoperatively and at postoperative follow-up visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients that are undergoing spinal fusion surgery to treat idiopathic scoliosis.
Key inclusion criteria (3 listed)
- Clinical diagnosis of idiopathic scoliosis
- Patients identified to undergo spinal fusion surgery
- Treated at Duke University Medical Center
Key exclusion criteria (1 listed)
- Neuromuscular or congenital scoliosis
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
Change in Lower Quarter Y-Balance Test (YBT-LQ)
Time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
The YBT-LQ is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform.
Change in Functional Movement Screen (FMS)
Time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
The FMS is a screening tool used to identify limitations or asymmetries in movement patterns by executing seven motions. Activities include a deep squat, lunges, hurdle steps, a push-up, straight-leg raises, shoulder mobility assessments, and rotary stability assessments.
4 secondary outcomes
Change in Tegner Activity Scale
Time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Change in Marx Activity Scale
Time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Change in EQ-5D
Time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Change in SRS-22
Time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
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 28 Jun 2017.
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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.
Robert K Lark, MD principal investigator
Duke University
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 Adolescent Idiopathic Scoliosis, run by Duke University 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 3 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 28 Jun 2017. 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?
Change in Lower Quarter Y-Balance Test (YBT-LQ) (time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively). The study lists 2 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 28 Jun 2017.