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Spine Biomechanics During Gait Following Lower Extremity Treatment in Different Patient Groups

Primary Purpose

Leg Length Inequality, Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Ankle foot orthosis
Shoe insole
Modified shoe with sole lift
Sponsored by
University Children's Hospital Basel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Length Inequality

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Leg length inequality patients:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Diplegic cerebral palsy patients:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University Children's Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Leg length correction

Control of foot position 1

Control of foot position 2

Control

Arm Description

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.

The foot position in in a sample of 15 patients with hemiplegic cerebral palsy will be controlled by an ankle foot orthosis.

The foot position in in a sample of 15 patients with diplegic cerebral palsy will be controlled by an ankle foot orthosis.

A sample of 15 healthy controls from a simultaneously conducted study (UKBB-Spine-1315-1) will be used for comparative purposes.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 26, 2013
Last Updated
August 24, 2018
Sponsor
University Children's Hospital Basel
Collaborators
Swiss Federal Institute of Technology, Bern University of Applied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01803243
Brief Title
Spine Biomechanics During Gait Following Lower Extremity Treatment in Different Patient Groups
Official Title
The Measurement of Spine Dynamics During Gait for the Quantification of Intervention Outcomes in Patients With Different Pathologies
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Children's Hospital Basel
Collaborators
Swiss Federal Institute of Technology, Bern University of Applied Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Length Inequality, Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Leg length correction
Arm Type
Experimental
Arm Description
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.
Arm Title
Control of foot position 1
Arm Type
Experimental
Arm Description
The foot position in in a sample of 15 patients with hemiplegic cerebral palsy will be controlled by an ankle foot orthosis.
Arm Title
Control of foot position 2
Arm Type
Experimental
Arm Description
The foot position in in a sample of 15 patients with diplegic cerebral palsy will be controlled by an ankle foot orthosis.
Arm Title
Control
Arm Type
No Intervention
Arm Description
A sample of 15 healthy controls from a simultaneously conducted study (UKBB-Spine-1315-1) will be used for comparative purposes.
Intervention Type
Other
Intervention Name(s)
Ankle foot orthosis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Shoe insole
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Modified shoe with sole lift
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reliability of the enhanced trunk marker set for the measurement of spinal kinematics in patients with leg length inequality and cerebral palsy during gait.
Description
Parameters include lumbar, thoracic and cervical spine curvature angles in the sagittal and frontal planes and segmental rotation angles in the transverse plane.
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).
Title
Immediate changes in spinal kinematics in patients with leg length inequality and cerebral palsy during gait following an orthotic lower extremity treatment.
Description
Parameters include lumbar, thoracic and cervical spine curvature angles in the sagittal and frontal planes and segmental rotation angles in the transverse plane.
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).
Secondary Outcome Measure Information:
Title
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.
Description
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.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Leg length inequality patients: Inclusion Criteria: 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 Exclusion Criteria: 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: Inclusion Criteria: 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 Exclusion Criteria: 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 Diplegic cerebral palsy patients: Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinald Brunner, MD
Organizational Affiliation
University Children's Hospital Basel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan Schmid, PT, PhD
Organizational Affiliation
Swiss Federal Institute of Technology / Bern University of Applied Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Silvio Lorenzetti, PhD, DSc
Organizational Affiliation
Swiss Federal Institute of Technology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jacqueline Romkes, PhD
Organizational Affiliation
University Children's Hospital Basel
Official's Role
Study Director
Facility Information:
Facility Name
University Children's Hospital Basel
City
Basel
ZIP/Postal Code
4056
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
27543740
Citation
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.
Results Reference
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Spine Biomechanics During Gait Following Lower Extremity Treatment in Different Patient Groups

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