Leg Length InequalityNCT01803243
Spine Biomechanics During Gait Following Lower Extremity Treatment in Different Patient Groups
A study testing Ankle foot orthosis, Shoe insole and Modified shoe with sole lift in people with Leg Length Inequality and Cerebral Palsy, run by University Children's Hospital Basel at 1 site in Switzerland.
Trial summary
Measuring spine dynamics is a necessity in order to better understand gait deviations throughout the whole body and to evaluate treatment effects on spinal movement during gait. However, the full body marker sets that are typically used in opto-electronic 3D gait analyses either disregard the spine entirely or regard… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Leg Length Inequality, Cerebral Palsy
- What is being tested?
- Ankle foot orthosis, Shoe insole and Modified shoe with sole lift
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2013to Jul 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed structural leg length inequality (minimum 1% of body height)
- Several different aetiologies (except neurological)
- Able to walk a distance of minimum 50 meters without any assistive device
- Diagnosed hemiplegic cerebral palsy (Gross Motor Function Classification System for Cerebral Palsy (GMFCS): Levels I and II)
- Able to walk a distance of minimum 50 meters barefoot and without any assistive device
- Diagnosed diplegic cerebral palsy (Gross Motor Function Classification System for Cerebral Palsy (GMFCS): Levels I and II)
- Able to walk a distance of minimum 50 meters barefoot and without any assistive device
Who cannot join
- Leg length inequality due to neurological aetiology
- Structural deformities of the spine
- Obesity (> 95th BMI-per-age percentile)
- Injuries of the locomotor system which led to persistent deformities
- Hemiplegic cerebral palsy patients:
- Structural deformities of the spine
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- Any previous surgical and casting treatments as well as botulinumtoxin treatments within preceding 6 months.
- Obesity (> 95th BMI-per-age percentile)
- Injuries of the locomotor system which led to persistent deformities
- Diplegic cerebral palsy patients:
- Structural deformities of the spine
- Any previous surgical and casting treatments as well as botulinumtoxin treatments within preceding 6 months.
- Obesity (> 95th BMI-per-age percentile)
- Injuries of the locomotor system which led to persistent deformities
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
Measuring spine dynamics is a necessity in order to better understand gait deviations throughout the whole body and to evaluate treatment effects on spinal movement during gait. However, 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 use an enhanced trunk marker set in order to evaluate the biomechanical effects of lower extremity treatments on spine dynamics in patients with different pathologies.
It has been hypothesized that
Read more
- the enhanced trunk marker set is a reliable method for the measurement of spine dynamics during gait in patients with deviations occurring secondary to leg length inequality.
- the enhanced trunk marker set is a reliable method for the measurement of spine dynamics during gait in patients that present both primary and secondary deviations such as seen in hemiplegic and diplegic cerebral palsy.
- treatment by means of either a shoe insole or a modified shoe with sole lift on the shorter side has an effect on spine dynamics during gait in patients with leg length inequality.
- treatment by means of an ankle foot orthosis to control the foot position has an effect on spine dynamics during gait in patients with hemiplegic and diplegic cerebral palsy.
To verify the hypotheses, instrumented gait analyses with a standard full body marker set and the enhanced trunk marker set will be carried out before and immediately after an orthotic lower extremity treatment in the respective patient group.
- Conditions
- Leg Length Inequality, Cerebral Palsy
- Being tested
- Ankle foot orthosis, Shoe insole, Modified shoe with sole lift
- Medical subject headings
- Leg Length Inequality, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle foot orthosisOther
Ankle foot orthoses are a common treatment method to control the foot position during walking and to prevent ankle plantar flexion contractures in cerebral palsy patients.
Shoe insoleOther
The heel of the shorter leg of the patient is lifted by a shoe insole. This procedure is commonly applied with leg length differences of up to 20mm.
Modified shoe with sole liftOther
The heel of the shorter leg of the patient is lifted by building up the sole of the shoe (shoe sole lift). This procedure is commonly applied with leg length differences of 20mm and more.
| Study group | Role | What they receive |
|---|---|---|
| Leg length correction | Experimental | The shorter leg in a sample of 15 patients with structural leg length inequality will be corrected by either a shoe insole or a modified shoe with sole lift. Receives: Other: Shoe insole; Other: Modified shoe with sole lift |
| Control of foot position 1 | Experimental | The foot position in in a sample of 15 patients with hemiplegic cerebral palsy will be controlled by an ankle foot orthosis. Receives: Other: Ankle foot orthosis |
| Control of foot position 2 | Experimental | The foot position in in a sample of 15 patients with diplegic cerebral palsy will be controlled by an ankle foot orthosis. Receives: Other: Ankle foot orthosis |
| Control | No intervention | A sample of 15 healthy controls from a simultaneously conducted study (UKBB-Spine-1315-1) will be used for comparative purposes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of the enhanced trunk marker set for the measurement of spinal kinematics in patients with leg length inequality and cerebral palsy 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 2015. Each patient will be measured before and immediately after an orthotic treatment (both measurements within 1 hour).
Immediate changes in spinal kinematics in patients with leg length inequality and cerebral palsy during gait following an orthotic lower extremity treatment.
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 2015. Each patient will be measured before and immediately after the orthotic treatment (both measurements within 1 hour).
Secondary outcomes (1)
Immediate changes in spatio-temporal gait parameters and kinematics and kinetics of peripheral joints in patients with leg length inequality and cerebral palsy during gait following an orthotic lower extremity treatment.
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 2015. Each patient will be measured before and immediately after the orthotic treatment (both measurements within 1 hour).
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 startJul 2013
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leg Length InequalityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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 Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803243
- Sponsor's protocol ID
- UKBB-Spine-1315-2
- Status last verified
- Aug 2018
- First submitted
- 26 Feb 2013
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmid S, Romkes J, Taylor WR, Lorenzetti S, Brunner R. Orthotic correction of lower limb function during gait does not immediately influence spinal kinematics in spastic hemiplegic cerebral palsy. Gait Posture. 2016 Sep;49:457-462. doi: 10.1016/j.gaitpost.2016.08.013. Epub 2016 Aug 12.
PubMed 27543740
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. 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
- NCT01803243
- Acronym / sponsor ID
- UKBB-Spine-1315-2
- Conditions
- Leg Length Inequality, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 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
- Jul 2013
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (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.
Measuring spine dynamics is a necessity in order to better understand gait deviations throughout the whole body and to evaluate treatment effects on spinal movement during gait. However, 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 use an enhanced trunk marker set in order to evaluate the biomechanical effects of lower extremity treatments on spine dynamics in patients with different pathologies.
It has been hypothesized that
- the enhanced trunk marker set is a reliable method for the measurement of spine dynamics during gait in patients with deviations occurring secondary to leg length inequality.
- the enhanced trunk marker set is a reliable method for the measurement of spine dynamics during gait in patients that present both primary and secondary deviations such as seen in hemiplegic and diplegic cerebral palsy.
- treatment by means of either a shoe insole or a modified shoe with sole lift on the shorter side has an effect on spine dynamics during gait in patients with leg length inequality.
- treatment by means of an ankle foot orthosis to control the foot position has an effect on spine dynamics during gait in patients with hemiplegic and diplegic cerebral palsy.
To verify the hypotheses, instrumented gait analyses with a standard full body marker set and the enhanced trunk marker set will be carried out before and immediately after an orthotic lower extremity treatment in the respective patient group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Leg length correction | Experimental | Other: Shoe insole, Other: Modified shoe with sole liftThe shorter leg in a sample of 15 patients with structural leg length inequality will be corrected by either a shoe insole or a modified shoe with sole lift. |
| Control of foot position 1 | Experimental | Other: Ankle foot orthosisThe foot position in in a sample of 15 patients with hemiplegic cerebral palsy will be controlled by an ankle foot orthosis. |
| Control of foot position 2 | Experimental | Other: Ankle foot orthosisThe foot position in in a sample of 15 patients with diplegic cerebral palsy will be controlled by an ankle foot orthosis. |
| Control | No intervention | –A sample of 15 healthy controls from a simultaneously conducted study (UKBB-Spine-1315-1) will be used for comparative purposes. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Diagnosed structural leg length inequality (minimum 1% of body height)
- Several different aetiologies (except neurological)
- Able to walk a distance of minimum 50 meters without any assistive device
- Diagnosed hemiplegic cerebral palsy (Gross Motor Function Classification System for Cerebral Palsy (GMFCS): Levels I and II)
- Able to walk a distance of minimum 50 meters barefoot and without any assistive device
Key exclusion criteria (14 listed)
- Leg length inequality due to neurological aetiology
- Structural deformities of the spine
- Obesity (> 95th BMI-per-age percentile)
- Injuries of the locomotor system which led to persistent deformities
- Structural deformities of the spine
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 |
|---|---|---|
| Ankle foot orthosisAnkle foot orthoses are a common treatment method to control the foot position during walking and to prevent ankle plantar flexion contractures in cerebral palsy patients. | Other | Control of foot position 1, Control of foot position 2 |
| Shoe insoleThe heel of the shorter leg of the patient is lifted by a shoe insole. This procedure is commonly applied with leg length differences of up to 20mm. | Other | Leg length correction |
| Modified shoe with sole liftThe heel of the shorter leg of the patient is lifted by building up the sole of the shoe (shoe sole lift). This procedure is commonly applied with leg length differences of 20mm and more. | Other | Leg length correction |
Primary outcome
Reliability of the enhanced trunk marker set for the measurement of spinal kinematics in patients with leg length inequality and cerebral palsy during gait.
Time frame: Data will be collected between April 2013 and June 2015. Each patient will be measured before and immediately after an orthotic treatment (both measurements within 1 hour).
Parameters include lumbar, thoracic and cervical spine curvature angles in the sagittal and frontal planes and segmental rotation angles in the transverse plane.
Immediate changes in spinal kinematics in patients with leg length inequality and cerebral palsy during gait following an orthotic lower extremity treatment.
Time frame: Data will be collected between April 2013 and June 2015. Each patient will be measured before and immediately after the orthotic treatment (both measurements within 1 hour).
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
Immediate changes in spatio-temporal gait parameters and kinematics and kinetics of peripheral joints in patients with leg length inequality and cerebral palsy during gait following an orthotic lower extremity treatment.
Time frame: Data will be collected between April 2013 and June 2015. Each patient will be measured before and immediately after the orthotic treatment (both measurements within 1 hour).
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 Aug 2018.
- Results publication: PubMed 27543740Schmid S, Romkes J, Taylor WR, Lorenzetti S, Brunner R. Orthotic correction of lower limb function during gait does not immediately influence spinal kinematics in spastic hemiplegic cerebral palsy. Gait Posture. 2016 Sep;49:457-462. doi: 10.1016/j.gaitpost.2016.08.013. Epub 2016 Aug 12.
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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?
A study testing Ankle foot orthosis, Shoe insole and Modified shoe with sole lift in people with Leg Length Inequality and Cerebral Palsy, 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 7 inclusion and 14 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 Aug 2018. 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?
Reliability of the enhanced trunk marker set for the measurement of spinal kinematics in patients with leg length inequality and cerebral palsy during gait. (time frame: Data will be collected between April 2013 and June 2015. Each patient will be measured before and immediately after an orthotic treatment (both measurements within 1 hour).). 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?
On the ClinicalTrials.gov record for NCT01803243, which also lists 1 linked publication.
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 Aug 2018.