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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Leg Length Inequality Cerebral Palsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Leg length correction

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.

Group Type EXPERIMENTAL

Shoe insole

Intervention Type OTHER

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

Intervention Type OTHER

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.

Control of foot position 1

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

Group Type EXPERIMENTAL

Ankle foot orthosis

Intervention Type OTHER

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.

Control of foot position 2

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

Group Type EXPERIMENTAL

Ankle foot orthosis

Intervention Type OTHER

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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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

* 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

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:

* 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:

* 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

Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No