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

NCT01803243 | Completed

• 1 other identifier: UKBB-Spine-1315-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

1. 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. 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. 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. 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.

Conditions

Leg Length Inequality; Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 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.

  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).

Study Arms (4)

Leg length correction

EXPERIMENTAL

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.

Other: Shoe insole; Other: Modified shoe with sole lift

Control of foot position 1

EXPERIMENTAL

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

Other: Ankle foot orthosis

Control of foot position 2

EXPERIMENTAL

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

Other: Ankle foot orthosis

Control

NO INTERVENTION

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

Interventions

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.

Control of foot position 1; Control of foot position 2

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.

Leg length correction

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.

Leg length correction

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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:
• 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
• Structural deformities of the spine

Sponsors & Collaborators

• University Children's Hospital Basel: lead
• Swiss Federal Institute of Technology: collaborator
• Bern University of Applied Sciences: collaborator

Study Sites (1)

University Children's Hospital Basel

Basel, 4056, Switzerland

Location

Related 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.gaitpost.2016.08.013. Epub 2016 Aug 12.

  PMID: 27543740 RESULT

MeSH Terms

Conditions

Leg Length Inequality; Cerebral Palsy

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Reinald Brunner, MD

  University Children's Hospital Basel

  PRINCIPAL INVESTIGATOR

• Stefan Schmid, PT, PhD

  Swiss Federal Institute of Technology / Bern University of Applied Sciences

  STUDY CHAIR

• Silvio Lorenzetti, PhD, DSc

  Swiss Federal Institute of Technology

  STUDY DIRECTOR

• Jacqueline Romkes, PhD

  University Children's Hospital Basel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Charge, Neuro-Orthopedics

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 4, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

CH (1)