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SDR Monitoring in Children With Cerebral Palsy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03079362
Enrollment
148
Registered
2017-03-14
Start date
2007-01-15
Completion date
2015-12-02
Last updated
2018-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

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.

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 21 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* \> 21 years

Design outcomes

Primary

MeasureTime frame
The frequency distribution pattern of the grading assessed by SDR monitoring Electromyogram (EMG) procedureDuring the operation

Secondary

MeasureTime frameDescription
Gait analysis instrumented three dimensionalUp to 12 months
StrengthUp to 12 months
SpasticityUp to 12 months
Range of motionUp to 12 months
GaitUp to 12 months
Functions scoresUp to 12 months
Gross motor function classification systemUp to 12 months
Modified Ashworth ScaleUp to 12 months
Therapy of adverse reactions of pain therapyUp to 12 months
InfectionsUp to 12 months
DeliriumUp to 12 monthsMeasured by Nu-DESC
Routine laboratoryUp to 12 months
Gross motor function measureUp to 12 months
TemperatureParticipants will be followed for the duration of hospital stay, an expected average of 7 days
Satisfaction with pain therapyUp to 12 monthsRating scale
Positional control of epiperidural catheterParticipants will be followed for the duration of hospital stay, an expected average of 7 days
ReoperationsUp to 12 months
Intensive care unit length of stayParticipants will be followed for the duration of hospital stay, an expected average of 1 day
Length of hospital stayParticipants will be followed for the duration of hospital stay, an expected average of 7 days
Ready to dischargeParticipants will be followed for the duration of hospital stay, an expected average of 7 daysMeasured Pads-Score
Duration of ventilationParticipants will be followed for the duration of intensive care unit stay, an expected average of 1 dayMeasured in days and hours
PainUp to 12 monthsMeasured by scales
Organ complicationsUp to 12 months
Adverse reactions of pain therapyUp to 12 months
Pain therapyUp to 12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026