SDR Monitoring in Children With Cerebral Palsy

Completed

• Conditions: Cerebral Palsy

• Registration Number: NCT03079362
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-15
• Primary Completion: 2014-11-27
• Study Completion: 2015-12-02
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-14
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-02
• Last Update Posted: 2018-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

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

Exclusion Criteria

• > 21 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency distribution pattern of the grading assessed by SDR monitoring Electromyogram (EMG) procedure	During the operation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité University Medicine -Berlin; 🇩🇪 Berlin, Germany