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

University Children's Hospital Basel

Status: Completed

Conditions: Cerebral Palsy; Leg Length Inequality

Treatments: Other: Shoe insole; Other: Ankle foot orthosis; Other: Modified shoe with sole lift

Study type: Interventional

Funder types: Other

Identifiers

NCT01803243

UKBB-Spine-1315-2

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Leg length correction

Experimental group

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.

Treatment:

Other: Shoe insole

Other: Modified shoe with sole lift

Control of foot position 1

Experimental group

Description:

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

Treatment:

Other: Ankle foot orthosis

Control of foot position 2

Experimental group

Description:

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

Treatment:

Other: Ankle foot orthosis

Control

No Intervention group

Description:

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