Outcome After Selective Dorsal Rhizothomy Concerning Life Quality, Cerebral Imaging and Cognition
SDR-Auswertung, Unterteil Kognition, Bildgebung, Lebensqualität
1 other identifier
observational
180
1 country
1
Brief Summary
Selektive 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2017
CompletedFirst Posted
Study publicly available on registry
June 7, 2017
CompletedStudy Start
First participant enrolled
October 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJuly 19, 2018
July 1, 2018
4 years
June 5, 2017
July 17, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Motor function measured by GMFCS
Ability of a child to perform specified motor tasks, measured by GMFCS and GMFM-88
5 years
Motor function measured by GMFM-88
Ability of a child to perform specified motor tasks, measured by GMFCS and GMFM-88
5 years
Secondary Outcomes (6)
Quality of life measured by "Disabkids"-Questionaire (German version)
5 years
Quality of life measured by questionaire "kid screen"
5 years
Selective motor control
5 years
Spasticity by modified Ashworth scale
5 years
Spasticity by modified Tardieu scale
5 years
- +1 more secondary outcomes
Eligibility Criteria
All patients treated with SDR at the Charité University clinics and who are able to perform tasks according to study protocols are eligible to enroll.
You may qualify if:
- clinical diagnosis of cerebral palsy
- able to perform most tasks according to study protocols
- parents and physician decided to perform SDR
You may not qualify if:
- not able to perform any tasks according to study protocols
- no candidate for SDR
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charité University clinics
Berlin, 13353, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne K van Riesen, M.D.
social pediatric center, departement of neuropediatrics
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 5, 2017
First Posted
June 7, 2017
Study Start
October 14, 2017
Primary Completion
October 1, 2021
Study Completion
December 1, 2021
Last Updated
July 19, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share