Trial document




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  DRKS00012845

Trial Description

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Title

Outcome after selective dorsal rhizothomy concerning life quality, cerebral imaging and cognition

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Trial Acronym

SDR-KoBL

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URL of the Trial

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Brief Summary in Lay Language

Selective dorsal rhizotomy (SDR) has been used as treatment option in children suffering from cerebral palsy (CP) for several decades and multiple studies demonstrated its benefits. Nevertheless, there are still no proven strategies for patient selection, optimal point of time for the operation or pre- and postoperative therapies. At the social pediatric center we care for more than 150 children, who have received selective dorsal rhizotomy (SDR) for cerebral palsy. We aim to investigate the clinical follow up-data as well as additional data acquired through clinical routine investigations. The evaluation of the impact of selective motor control, cognition and cerebral imaging findings on the motor outcome and life quality in children with CP who underwent SDR at the Charité University clinics will clarify these critical points in daily care for patients with CP. All children who have received selective dorsal rhizotomy (SDR) at the Charité university clinics and who attended or plan to attend the follow up appointments at the social pediatric center are welcome to participate in the study. The study will only deal with clinical routine data. The children do not have to go through additional tests.

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Brief Summary in Scientific Language

Selective dorsal rhizotomy (SDR) has been used as treatment option in children suffering from cerebral palsy (CP) for several decades and multiple studies demonstrated its benefits. Nevertheless, there are still no proven strategies for patient selection, optimal point of time for the operation or pre- and postoperative therapies. The evaluation of the impact of selective motor control, cognition and cerebral imaging findings on the motor outcome and life quality in children with CP who underwent SDR at the Charité University clinics will clarify these critical points in daily care for patients with CP.

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Organizational Data

  •   DRKS00012845
  •   2017/08/07
  •   2017/06/05
  •   yes
  •   Approved
  •   EA2/167/16, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1200-0871 
  •   NCT03179241  (ClinicalTrials.gov ID)
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Health Condition or Problem studied

  •   G80.8 -  Other cerebral palsy
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Interventions/Observational Groups

  •   Patients who received or will receive selective dorsal rhizotomy due to cerebral palsy may participate in the study. Patients and their parents once have to allow investigations on further clinical evaluations, that may have been performed elsewhere. Parents/ patients agree, that data may be stored under a pseudonym and may be analyzed after being anonymized and published. No further tests have to be performed. Patients or their parents do not need to visit the study cite again.
    Only available data from routine clinical care will be gathered. Especially data on cognition (e.g. MüFED, Bailey-Scales of infant development, K-ABC, SON-R) and radiographic data (spinal and cranial MRI, ultrasound) shall be collected. If these kind of data were never evaluated in a certain patient, there is no need for doing any further tests. The evaluations may have been done before visiting the SPZ Neuropädiatrie for the first time or thereafter. Only data available until the point of time of study recruiting will be collected.
    The routinely clinical evaluation after selective dorsal rhizotomy will not be affected by participating in this study. The routine diagnostics are gait laboratory (if child is able to walk), joint-range-of-motion (ROM), spasticity (MAS, Tardieu), strength (Janda), motorfunction (GMFM-88, bzw. GMFM-66), quality of life (KidScreen, DisabKids) and clinical routine questions on cerebral palsy concerning therapies, pain and orthopedic aids before selective dorsal rhizotomy as well as after 3 / 6 / 12 / 24 und 60 months after SDR.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Motor functions, measured before SDR (selective dorsal rhizotomy) and 2 and 5 years postoperatively via GMFM88

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Secondary Outcome

Life quality, measured before SDR and 2 and 5 years post-SDR, via DisabKids and KidScreen

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2017/08/10
  •   182
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   2   Years
  •   35   Years
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Additional Inclusion Criteria

clinical diagnosis of cerebral palsy;
able to perform most tasks according to study protocols;
parents and physician decided to perform SDR;
SDR was performed after 2006 at the Charité university clinics

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Exclusion Criteria

not able to perform any tasks according to study protocols
no candidate for SDR

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Addresses

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    • SPZ Abteilung Neuropädiatrie
    • Ms.  Dr. med.  Anne  van Riesen 
    • Augustenburgerplatz 1
    • 13353  Berlin
    • Germany
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    • SPZ Abteilung Neuropädaitrie
    • Ms.  Dr. med.  Anne  van Riesen 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • SPZ Abteilung Neuropädiatrie
    • Ms.  Katja  Rohner 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • SPZ Abteilung NeuropädiatrieCharité Campus Virchow-Klinikum
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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