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

Cerebral Palsy Clinical Trial

Official title:

The Measurement of Spine Dynamics During Gait for the Quantification of Intervention Outcomes in Patients With Different Pathologies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803243
• Other study ID #: UKBB-Spine-1315-2
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: University Children's Hospital Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

1. 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.

2. 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.

3. 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.

4. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Leg Length Inequality

Intervention

Other:
• Ankle foot orthosis
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 insole
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 lift
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.

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Basel	Basel

Sponsors (3)

Lead Sponsor	Collaborator
University Children's Hospital Basel	Bern University of Applied Sciences, Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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.gaitpos — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).
Primary	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.	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	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.	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).