SDR Monitoring in Children With Cerebral Palsy

January 2, 2018 updated by: Claudia Spies, Charite University, Berlin, Germany

SDR Monitoring in Children With Cerebral Palsy - a Retrospective Cohort Study

The study evaluates the anatomical distribution of the assessed Electromyogram (EMG) responses ensuring after sensory nerve root stimulation and obtained IOM grading during selective dorsal rhizotomy (SDR) with regard to level and, side of the body and gender as well as pain management and outcome data.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

148

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
        • Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité University Medicine -Berlin

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 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Male and female pediatric and adolescent patients undergoing SDR

Description

Inclusion Criteria:

  • Male and female children with spastic cerebral palsy undergoing selective dorsal rhizotomy surgery including intraoperative neuromonitoring

Exclusion Criteria:

  • > 21 years

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

Cohorts and Interventions

Group / Cohort
Children
Children who underwent selective dorsal rhizotomy (SDR) including intraoperative neuromonitoring (IOM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The frequency distribution pattern of the grading assessed by SDR monitoring Electromyogram (EMG) procedure
Time Frame: During the operation
During the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Range of motion
Time Frame: Up to 12 months
Up to 12 months
Intensive care unit length of stay
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Ready to discharge
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Measured Pads-Score
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Duration of ventilation
Time Frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day
Measured in days and hours
Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day
Pain
Time Frame: Up to 12 months
Measured by scales
Up to 12 months
Organ complications
Time Frame: Up to 12 months
Up to 12 months
Adverse reactions of pain therapy
Time Frame: Up to 12 months
Up to 12 months
Therapy of adverse reactions of pain therapy
Time Frame: Up to 12 months
Up to 12 months
Infections
Time Frame: Up to 12 months
Up to 12 months
Delirium
Time Frame: Up to 12 months
Measured by Nu-DESC
Up to 12 months
Routine laboratory
Time Frame: Up to 12 months
Up to 12 months
Pain therapy
Time Frame: Up to 12 months
Up to 12 months
Temperature
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Satisfaction with pain therapy
Time Frame: Up to 12 months
Rating scale
Up to 12 months
Positional control of epiperidural catheter
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Reoperations
Time Frame: Up to 12 months
Up to 12 months
Gross motor function measure
Time Frame: Up to 12 months
Up to 12 months
Gait analysis instrumented three dimensional
Time Frame: Up to 12 months
Up to 12 months
Strength
Time Frame: Up to 12 months
Up to 12 months
Spasticity
Time Frame: Up to 12 months
Up to 12 months
Gait
Time Frame: Up to 12 months
Up to 12 months
Functions scores
Time Frame: Up to 12 months
Up to 12 months
Gross motor function classification system
Time Frame: Up to 12 months
Up to 12 months
Modified Ashworth Scale
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 15, 2007

Primary Completion (Actual)

November 27, 2014

Study Completion (Actual)

December 2, 2015

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

March 8, 2017

First Posted (Actual)

March 14, 2017

Study Record Updates

Last Update Posted (Actual)

January 4, 2018

Last Update Submitted That Met QC Criteria

January 2, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDR

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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