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Trial record 2 of 8 for:    cerebral palsy orthotics
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Spine Biomechanics During Gait Following Lower Extremity Treatment in Different Patient Groups

This study is not yet open for participant recruitment.
Verified April 2013 by University Children's Hospital Basel
Sponsor:
Collaborators:
Swiss Federal Institute of Technology
Bern University of Applied Sciences
Information provided by (Responsible Party):
Prof. Reinald Brunner, MD, University Children's Hospital Basel
ClinicalTrials.gov Identifier:
NCT01803243
First received: February 26, 2013
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Leg Length Inequality
Cerebral Palsy
 Other: Ankle foot orthosis
Other: Shoe insole
Other: Modified shoe with sole lift

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Measurement of Spine Dynamics During Gait for the Quantification of Intervention Outcomes in Patients With Different Pathologies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Children's Hospital Basel:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    Parameters include lumbar, thoracic and cervical spine curvature angles in the sagittal and frontal planes and segmental rotation angles in the transverse plane.

  • 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). ] [ Designated as safety issue: No ]
    Parameters include lumbar, thoracic and cervical spine curvature angles in the sagittal and frontal planes and segmental rotation angles in the transverse plane.


Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 45
Study Start Date: April 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 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.
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.
Experimental: 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.
 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.
Experimental: 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.
 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.
No Intervention: Control
A sample of 15 healthy controls from a simultaneously conducted study (UKBB-Spine-1315-1) will be used for comparative purposes.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01803243

Contacts
Contact: Stefan Schmid, PT, MA +41318483796 stefanschmid79@gmail.com

Locations
Switzerland
University Children's Hospital Basel Not yet recruiting
Basel, Switzerland, 4056
Contact: Reinald Brunner, MD     +41617041802     reinaldbrunner@sunrise.ch    
Principal Investigator: Reinald Brunner, MD            
Sponsors and Collaborators
University Children's Hospital Basel
Swiss Federal Institute of Technology
Bern University of Applied Sciences
Investigators
Principal Investigator: Reinald Brunner, MD University Children's Hospital Basel
Study Chair: Stefan Schmid, PT, MA Swiss Federal Institute of Technology / Bern University of Applied Sciences
Study Director: Silvio Lorenzetti, PhD, ScD Swiss Federal Institute of Technology
Study Director: Jacqueline Romkes, PhD University Children's Hospital Basel
  More Information

Publications:

Responsible Party: Prof. Reinald Brunner, MD, Doctor in Charge, Neuro-Orthopedics, University Children's Hospital Basel
ClinicalTrials.gov Identifier: NCT01803243     History of Changes
Other Study ID Numbers: UKBB-Spine-1315-2
Study First Received: February 26, 2013
Last Updated: April 17, 2013
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Cerebral Palsy
Leg Length Inequality
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013