Outcome After Selective Dorsal Rhizothomy Concerning Life Quality, Cerebral Imaging and Cognition

July 17, 2018 updated by: Anne van Riesen, Charite University, Berlin, Germany

SDR-Auswertung, Unterteil Kognition, Bildgebung, Lebensqualität

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

SDR at the Charité University clinics. Two study visits before surgery and during the follow-up 3 months, 6 months, 12 months, 24 months and 5 years post-operatively.

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Charité University clinics
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • clinical diagnosis of cerebral palsy
  • able to perform most tasks according to study protocols
  • parents and physician decided to perform SDR

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor function measured by GMFCS
Time Frame: 5 years
Ability of a child to perform specified motor tasks, measured by GMFCS and GMFM-88
5 years
Motor function measured by GMFM-88
Time Frame: 5 years
Ability of a child to perform specified motor tasks, measured by GMFCS and GMFM-88
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life measured by "Disabkids"-Questionaire (German version)
Time Frame: 5 years
Measured by "Disabkids"-Questionaire (German version) and "kid screen"
5 years
Quality of life measured by questionaire "kid screen"
Time Frame: 5 years
Measured by "kid screen"
5 years
Selective motor control
Time Frame: 5 years
Measured by SCALE (Fowler et al., 2009)
5 years
Spasticity by modified Ashworth scale
Time Frame: 5 years
Measured by modified Ashworth scale and Tardieu scale
5 years
Spasticity by modified Tardieu scale
Time Frame: 5 years
Measured by modified Ashworth scale and Tardieu scale
5 years
Contractures by range of motion (ROM)
Time Frame: 5 years
Measured by range of motion (ROM)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Anne K van Riesen, M.D., social pediatric center, departement of neuropediatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2017

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

June 5, 2017

First Submitted That Met QC Criteria

June 5, 2017

First Posted (Actual)

June 7, 2017

Study Record Updates

Last Update Posted (Actual)

July 19, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDR-KoBL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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