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

Cerebral Palsy, Spastic Clinical Trial

Official title:

SDR-Auswertung, Unterteil Kognition, Bildgebung, Lebensqualität

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03179241
• Other study ID #: SDR-KoBL
• Status: Recruiting
• Start date: October 14, 2017
• Est. completion date: December 1, 2021

Study information

• Verified date: July 2018
• Source: Charite University, Berlin, Germany
• Contact: Anne K van Riesen, M.D.
• Phone: +4930450666547
• Email: anne.van-riesen[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic

Locations

Country	Name	City	State
Germany	Charité University clinics	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor function measured by GMFCS	Ability of a child to perform specified motor tasks, measured by GMFCS and GMFM-88	5 years
Primary	Motor function measured by GMFM-88	Ability of a child to perform specified motor tasks, measured by GMFCS and GMFM-88	5 years
Secondary	Quality of life measured by "Disabkids"-Questionaire (German version)	Measured by "Disabkids"-Questionaire (German version) and "kid screen"	5 years
Secondary	Quality of life measured by questionaire "kid screen"	Measured by "kid screen"	5 years
Secondary	Selective motor control	Measured by SCALE (Fowler et al., 2009)	5 years
Secondary	Spasticity by modified Ashworth scale	Measured by modified Ashworth scale and Tardieu scale	5 years
Secondary	Spasticity by modified Tardieu scale	Measured by modified Ashworth scale and Tardieu scale	5 years
Secondary	Contractures by range of motion (ROM)	Measured by range of motion (ROM)	5 years