SDR Monitoring in Children With Cerebral Palsy

Study Overview
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Brief Summary
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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.

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

Conditions
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Cerebral Palsy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female children with spastic cerebral palsy undergoing selective dorsal rhizotomy surgery including intraoperative neuromonitoring Exclusion Criteria: > 21 years

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children<br>Children who underwent selective dorsal rhizotomy (SDR) including intraoperative neuromonitoring (IOM) | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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