ScoliosisNCT01803256
Possibilities and Limitations of a New Method for the Measurement of Spine Dynamics During Gait
An observational study of Scoliosis, run by University Children's Hospital Basel at 1 site in Switzerland.
Trial summary
The full body marker sets that are typically used in opto-electronic 3D gait analyses either disregard the spine entirely or regard it as a rigid structure. Therefore, the purpose of this study is to identify the possibilities and limitations of an enhanced trunk marker set for the measurement of spine dynamics during… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2013to Jan 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Scoliosis patients: Patients attending the Orthopedic Department at UKBB for scoliosis treatment. Healthy controls: Middle and high school students in the Basel area.
Who may be able to join
- Adolescent idiopathic scoliosis
- Able to walk a distance of minimum 50 meters barefoot and without any assistive device
Who cannot join
- Other types of scoliosis (e.g. of neurological origin)
- Previous treatment of scoliosis (conservative or surgery)
- Injuries of the locomotor system which led to persistent deformities
- Healthy controls:
- Any pathologies or diseases affecting the locomotor system
- Injuries to the locomotor system which led to persistent deformities
- Obesity (> 95th BMI-per-age percentile)
- Leg length discrepancy (more than 1% of body height)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Measurement of Spine Dynamics During Gait for the Quantification of Intervention Outcomes in Patients With Different Pathologies
The full body marker sets that are typically used in opto-electronic 3D gait analyses either disregard the spine entirely or regard it as a rigid structure. Therefore, the purpose of this study is to identify the possibilities and limitations of an enhanced trunk marker set for the measurement of spine dynamics during gait in adolescents with and without structural spine deformities.
It has been hypothesized that the enhance trunk marker set:
Read more
- is a valid method for the measurement of spine deformations in the sagittal, frontal and indirectly transverse planes.
- is an applicable and reliable method for the measurement of spine dynamics during gait in healthy adolescents and in patients with structural deformities such as seen in scoliosis.
- is sensitive enough to distinguish the spinal movement pattern during gait measured in scoliosis patients from the one measured in healthy adolescents.
To verify the hypotheses, the following measurements will be carried out:
- Biplanar radiographs (a-p and lateral) with radio-opaque markers in scoliosis patients.
- Instrumented gait analysis with a standard full body marker set and the enhanced trunk marker set in scoliosis patients and healthy controls.
- Conditions
- Scoliosis
- Medical subject headings
- Scoliosis
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 |
|---|---|---|
| Scoliosis patients: | 15 patients with adolescent idiopathic scoliosis. | |
| Control subjects: | 15 adolescent healthy control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of the enhanced trunk marker set for a static measurement of spinal kinematics (radiographic vs. motion analysis measurements).
This primary endpoint will only be evaluated in scoliosis patients since healthy adolescents do not undergo radiographic measurements. Parameters include lumbar and thoracic spine curvature angles in the sagittal and frontal planes.
Measured: Data will be collected between April 2013 and June 2014. For each scoliosis patient, the radiographic measurements will be conducted immediately after inclusion and the motion analysis measurements within 48 hours of the radiographic measurements.
Reliability of the enhanced trunk marker set for the measurement of spinal kinematics in scoliosis patients and healthy adolescents during gait.
Parameters include lumbar, thoracic and cervical spine curvature angles in the sagittal and frontal planes and segmental rotation angles in the transverse plane.
Measured: Data will be collected between April 2013 and June 2014. Spinal kinematics during gait will be measured in each scoliosis patient / healthy adolescent within 48 hours of the radiographic examination.
Differences in spinal kinematics between scoliosis patients and healthy adolescents during gait.
Parameters include lumbar, thoracic and cervical spine curvature angles in the sagittal and frontal planes and segmental rotation angles in the transverse plane.
Measured: Data will be collected between April 2013 and June 2014. Spinal kinematics during gait will be measured in each scoliosis patient / healthy adolescent within 48 hours of the radiographic examination.
Secondary outcomes (1)
Differences in spatio-temporal gait parameters and kinematics and kinetics of peripheral joints between scoliosis patients and healthy adolescents during gait.
Parameters include gait speed, cadence and single and double limb support as well as angles, torques and powers of peripheral joints in all three planes.
Measured: Data will be collected between April 2013 and June 2014. Parameters during gait will be measured in each scoliosis patient / healthy adolescent within 48 hours of the radiographic examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2014
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Basel
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology, Bern University of Applied Sciences
- Responsible party
- Principal investigator, Prof. Reinald Brunner, MD, University Children's Hospital Basel
- Investigators
- Reinald Brunner, MD, Principal investigator, University Children's Hospital BaselStefan Schmid, PT, PhD, Study chair, Swiss Federal Institute of Technology / Bern University of Applied SciencesSilvio Lorenzetti, PhD, DSc, Study director, Swiss Federal Institute of TechnologyJacqueline Romkes, PhD, Study director, University Children's Hospital BaselCarol-Claudius Hasler, MD, Study director, University Children's Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803256
- Sponsor's protocol ID
- UKBB-Spine-1315-1
- Status last verified
- Nov 2016
- First submitted
- 26 Feb 2013
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmid S, Studer D, Hasler CC, Romkes J, Taylor WR, Brunner R, Lorenzetti S. Using Skin Markers for Spinal Curvature Quantification in Main Thoracic Adolescent Idiopathic Scoliosis: An Explorative Radiographic Study. PLoS One. 2015 Aug 13;10(8):e0135689. doi: 10.1371/journal.pone.0135689. eCollection 2015.
PubMed 26270557Schmid S, Studer D, Hasler CC, Romkes J, Taylor WR, Lorenzetti S, Brunner R. Quantifying spinal gait kinematics using an enhanced optical motion capture approach in adolescent idiopathic scoliosis. Gait Posture. 2016 Feb;44:231-7. doi: 10.1016/j.gaitpost.2015.12.036. Epub 2015 Dec 29.
PubMed 27004664
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Measurement of Spine Dynamics During Gait for the Quantification of Intervention Outcomes in Patients With Different Pathologies
- ClinicalTrials.gov ID
- NCT01803256
- Acronym / sponsor ID
- UKBB-Spine-1315-1
- Conditions
- Scoliosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Children's Hospital BaselUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology, Bern University of Applied Sciences
- Study start
- Apr 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Mar 2013 (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 full body marker sets that are typically used in opto-electronic 3D gait analyses either disregard the spine entirely or regard it as a rigid structure. Therefore, the purpose of this study is to identify the possibilities and limitations of an enhanced trunk marker set for the measurement of spine dynamics during gait in adolescents with and without structural spine deformities.
It has been hypothesized that the enhance trunk marker set:
- is a valid method for the measurement of spine deformations in the sagittal, frontal and indirectly transverse planes.
- is an applicable and reliable method for the measurement of spine dynamics during gait in healthy adolescents and in patients with structural deformities such as seen in scoliosis.
- is sensitive enough to distinguish the spinal movement pattern during gait measured in scoliosis patients from the one measured in healthy adolescents.
To verify the hypotheses, the following measurements will be carried out:
- Biplanar radiographs (a-p and lateral) with radio-opaque markers in scoliosis patients.
- Instrumented gait analysis with a standard full body marker set and the enhanced trunk marker set in scoliosis patients and healthy controls.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scoliosis patients: | – | –15 patients with adolescent idiopathic scoliosis. |
| Control subjects: | – | –15 adolescent healthy control subjects |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Scoliosis patients: Patients attending the Orthopedic Department at UKBB for scoliosis treatment. Healthy controls: Middle and high school students in the Basel area.
Key inclusion criteria (2 listed)
- Adolescent idiopathic scoliosis
- Able to walk a distance of minimum 50 meters barefoot and without any assistive device
Key exclusion criteria (8 listed)
- Other types of scoliosis (e.g. of neurological origin)
- Previous treatment of scoliosis (conservative or surgery)
- Injuries of the locomotor system which led to persistent deformities
- Any pathologies or diseases affecting the locomotor system
- Injuries to the locomotor system which led to persistent deformities
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
Validity of the enhanced trunk marker set for a static measurement of spinal kinematics (radiographic vs. motion analysis measurements).
Time frame: Data will be collected between April 2013 and June 2014. For each scoliosis patient, the radiographic measurements will be conducted immediately after inclusion and the motion analysis measurements within 48 hours of the radiographic measurements.
This primary endpoint will only be evaluated in scoliosis patients since healthy adolescents do not undergo radiographic measurements. Parameters include lumbar and thoracic spine curvature angles in the sagittal and frontal planes.
Reliability of the enhanced trunk marker set for the measurement of spinal kinematics in scoliosis patients and healthy adolescents during gait.
Time frame: Data will be collected between April 2013 and June 2014. Spinal kinematics during gait will be measured in each scoliosis patient / healthy adolescent within 48 hours of the radiographic examination.
Parameters include lumbar, thoracic and cervical spine curvature angles in the sagittal and frontal planes and segmental rotation angles in the transverse plane.
Differences in spinal kinematics between scoliosis patients and healthy adolescents during gait.
Time frame: Data will be collected between April 2013 and June 2014. Spinal kinematics during gait will be measured in each scoliosis patient / healthy adolescent within 48 hours of the radiographic examination.
Parameters include lumbar, thoracic and cervical spine curvature angles in the sagittal and frontal planes and segmental rotation angles in the transverse plane.
1 secondary outcome
Differences in spatio-temporal gait parameters and kinematics and kinetics of peripheral joints between scoliosis patients and healthy adolescents during gait.
Time frame: Data will be collected between April 2013 and June 2014. Parameters during gait will be measured in each scoliosis patient / healthy adolescent within 48 hours of the radiographic examination.
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 Nov 2016.
- Results publication: PubMed 26270557Schmid S, Studer D, Hasler CC, Romkes J, Taylor WR, Brunner R, Lorenzetti S. Using Skin Markers for Spinal Curvature Quantification in Main Thoracic Adolescent Idiopathic Scoliosis: An Explorative Radiographic Study. PLoS One. 2015 Aug 13;10(8):e0135689. doi: 10.1371/journal.pone.0135689. eCollection 2015.
- Results publication: PubMed 27004664Schmid S, Studer D, Hasler CC, Romkes J, Taylor WR, Lorenzetti S, Brunner R. Quantifying spinal gait kinematics using an enhanced optical motion capture approach in adolescent idiopathic scoliosis. Gait Posture. 2016 Feb;44:231-7. doi: 10.1016/j.gaitpost.2015.12.036. Epub 2015 Dec 29.
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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.
Reinald Brunner, MD principal investigator
University Children's Hospital Basel
Stefan Schmid, PT, PhD study chair
Swiss Federal Institute of Technology / Bern University of Applied Sciences
Silvio Lorenzetti, PhD, DSc study director
Swiss Federal Institute of Technology
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 University Children's Hospital Basel at 1 site in Switzerland.
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 8 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 Nov 2016. 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 Switzerland. 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?
Validity of the enhanced trunk marker set for a static measurement of spinal kinematics (radiographic vs. motion analysis measurements). (time frame: Data will be collected between April 2013 and June 2014. For each scoliosis patient, the radiographic measurements will be conducted immediately after inclusion and the motion analysis measurements within 48 hours of the radiographic measurements.). 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?
On the ClinicalTrials.gov record for NCT01803256, which also lists 2 linked publications.
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 Nov 2016.