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

• Conditions: Cerebral Palsy, Spastic

• Registration Number: NCT03179241
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-06-05
• Study First Submitted QC: 2017-06-05
• Study First Posted: 2017-06-07
• Study Start: 2017-10-14
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-19
• Primary Completion: 2021-10-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Motor function measured by GMFCS	5 years	Ability of a child to perform specified motor tasks, measured by GMFCS and GMFM-88
Motor function measured by GMFM-88	5 years	Ability of a child to perform specified motor tasks, measured by GMFCS and GMFM-88

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Charité University clinics; 🇩🇪 Berlin, Germany