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NCT Number: NCT01803243

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

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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Key information

Conditions

Leg Length Inequality Bone Diseases Bone Diseases, Developmental Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Musculoskeletal Diseases Nervous System Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Children's Hospital Basel

Basel, 4056, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ankle foot orthosis

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.

Shoe insole

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

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.

Primary outcomes

  1. 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.

  2. 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.

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.

    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 gait speed, cadence and single and double limb support as well as angles, torques and powers of peripheral joints in all three planes.

Sponsors and collaborators

Lead sponsor

University Children's Hospital Basel

Other

Collaborators

  • Bern University of Applied Sciences
  • Swiss Federal Institute of Technology

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Mar 4, 2013
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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