Trial document




drksid header

  DRKS00016407

Trial Description

start of 1:1-Block title

Title

Assessment of variables contributing to trophic differences between affected versus non-affected body side in children with unilateral movement disorders

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Trophic differences in hemiparesis

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Hemiparesis (unilateral movement disorders due to early childhood damage to the brain) can already occur in children during pregnancy, during childbirth or at a later stage of development. One in every 1,000 live births is affected and may be associated with relevant impairment of everyday life. This may be due, for example, to the difficulty of using the arms, difficulty walking, or additional complications (e.g., epilepsy). Sometimes there is a difference in (length) growth between the affected and unaffected body side. The difference in growth may affect both the subcutaneous fatty tissue, the muscle / connective tissue or the skeletal system and e.g. lead to a different arm / leg length and thickness. Therapies (physiotherapy, occupational therapy, orthopedic measures) often try to counteract this, but the triggers for the different growth are not yet well understood. This study looks for possible triggers for a difference in growth between the affected body side and the unaffected side.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Assessing growth is substantial for clinical approaches and therapy evaluations. Unilateral movement disorders are a motor disorder that affects one side of the body, and is the second most common subtype of CP. Many patients with unilateral movement disorders show a discrepancy between side-to-side growth, but it is still unclear which factors contribute to the trophic differences between sides.
The Aim of this study is to assess the variables contributing to trophic differences between the affected versus the non-affected body side in children with unilateral central movement disorders from different origin (such as cerebral palsy, pediatric stroke, traumatic brain damage, etc.).
This study will be a cross-sectional and descriptive study. Multiple variables will be assessed regarding their influence on growth in children with unilateral movement disorder, comparing the affected side to the non-affected side. As each patient represents his own “control-case”, we aim to detect patient and disease specific variables, which influence growth. The variables will be divided in groups referring to WHO ICF-CY domains (Body Structure, Body Function, and Activity).
The participants will be recruited from a population of 230 children with unilateral movement disorders across all ages which are continuously being treated in the outpatient clinic at the Dr. von Hauner Children’s Hospital (iSPZ Hauner, University of Munich) and from an inpatient rehabilitation clinic at the Pediatric Rehabilitation Center in Vogtareuth, Schön Klinik Vogtareuth. Patients will be assessed in a multidisciplinary approach including professionals from the department of Pediatric Neurology, Pediatric Endocrionology & Diabetology and Pediatric Neurorehabilitation.
Assessing growth is substantial for clinical approaches and therapy evaluations. Unilateral movement disorders are a motor disorder that affects one side of the body, and is the second most common subtype of CP. Many patients with unilateral movement disorders show a discrepancy between side-to-side growth, but it is still unclear which factors contribute to the trophic differences between sides.
The Aim of this study is to assess the variables contributing to trophic differences between the affected versus the non-affected body side in children with unilateral central movement disorders from different origin (such as cerebral palsy, pediatric stroke, traumatic brain damage, etc.).
This study will be a cross-sectional and descriptive study. Multiple variables will be assessed regarding their influence on growth in children with unilateral movement disorder, comparing the affected side to the non-affected side. As each patient represents his own “control-case”, we aim to detect patient and disease specific variables, which influence growth. The variables will be divided in groups referring to WHO ICF-CY domains (Body Structure, Body Function, and Activity).
The participants will be recruited from a population of 230 children with unilateral movement disorders across all ages which are continuously being treated in the outpatient clinic at the Dr. von Hauner Children’s Hospital (iSPZ Hauner, University of Munich) and from an inpatient rehabilitation clinic at the Pediatric Rehabilitation Center in Vogtareuth, Schön Klinik Vogtareuth. Patients will be assessed in a multidisciplinary approach including professionals from the department of Pediatric Neurology, Pediatric Endocrionology & Diabetology and Pediatric Neurorehabilitation.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00016407
  •   2018/12/21
  •   [---]*
  •   yes
  •   Approved
  •   18-759, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I63.9 -  Cerebral infarction, unspecified
  •   G81.1 -  Spastic hemiplegia
  •   G80.2 -  Spastic hemiplegic cerebral palsy
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   "• A routine clinical check up of the kid. We will measure the body, assess range of motion, and evaluate the movements. This will be done by a Pediatrician.
    • Sensitivity Testing of the Hand: We will do several games with our hands to see how sensitive they are. First, we will touch a finger of each hand with a thread and a paperclip, and your child can let us know what it feels. Then your child has to guess without seeing some objects by touching them.
    • Grip force measurement with a digital hand dynamometer in side comparison. The examination takes about 5 minutes.
    • Muscle ultrasound of the arms and legs in a side comparison (absolutely painless and without risk). This examination also takes max. 10 min.
    • Leonardo floor reaction force plate (weight, power and balance). This test procedure includes exercises for sitting, standing and various movements. The examination takes about 15 minutes.
    • BodPod measurement: with this examination, air displacement plethysmography can be used to measure the body density and thereby the body composition (fat mass and fat-free mass) in children and adults exactly. The examination takes approx. 15 minutes incl. Preparation and delivers fast, safe and high-precision results.
    • We would also like to take a blood sample (3 ml) at the same time to analyze various hormones and data (blood count including differential blood count, calcium, phosphate, alkaline phosphatase, vitamin D, parathyroid hormone, thyroid hormones), which influence body growth. The investigation takes place in the routine laboratory of Dr. Hauner Children's Hospital. There are no further examinations with the blood.
    Since not all instruments are in one place, a room change is required, the max. Duration of max. 120 minutes additionally explained."
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Leg length discrepancy (left and right in cm)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Magnetic Resonance Imaging Classification system (MIRCS) of the brain damage and growth difference, clinical assessment and growth differences

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2019/01/14
  •   50
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   2   Years
  •   18   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

All children with unilateral central movement disorder with diagnosis of infantile cerebral palsy (ICD-Code G80.2), hemiparesis and hemiplegia (ICD-Code G81.1) and Stroke (ICD-Code I63.9) from 2 to 18 years of age.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Children with additional chronic, genetic or metabolic disease that could affect or have affected their growth.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutscher Akademischer Austauschdienst e.V. (DAAD)
    • Kennedyallee 50
    • 53175  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   +49 228 882-0
    •   +49 228 882-444
    •   [---]*
    •   https://www.daad.de
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Enrolling by invitation
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.