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

SDR-Auswertung, Unterteil Kognition, Bildgebung, Lebensqualität

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03179241

Enrollment

180

Registered

2017-06-07

Start date

2017-10-14

Completion date

2021-12-01

Last updated

2018-07-19

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

Conditions

Cerebral Palsy, Spastic

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 25 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Spasticity by modified Ashworth scale	5 years	Measured by modified Ashworth scale and Tardieu scale
Spasticity by modified Tardieu scale	5 years	Measured by modified Ashworth scale and Tardieu scale
Quality of life measured by Disabkids-Questionaire (German version)	5 years	Measured by Disabkids-Questionaire (German version) and kid screen
Contractures by range of motion (ROM)	5 years	Measured by range of motion (ROM)
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)

Countries

Germany

Contacts

Primary ContactAnne K van Riesen, M.D.

anne.van-riesen@charite.de+4930450666547

Backup ContactAkosua S Sarpong-Bengelsdorf, M.D.

Akosua.Sarpong@charite.de+4930450566607

Outcome results