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

NCT ID: NCT03179241

Last Updated: 2018-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-14

Study Completion Date

2021-12-01

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy, Spastic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Anne van Riesen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne K van Riesen, M.D.

Role: PRINCIPAL_INVESTIGATOR

social pediatric center, departement of neuropediatrics

Locations

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Charité University clinics

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Anne K van Riesen, M.D.

Role: CONTACT

+4930450666547

Akosua S Sarpong-Bengelsdorf, M.D.

Role: CONTACT

+4930450566607

Facility Contacts

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Anne K van Riesen, MD

Role: primary

0049 30 450 566 ext. 443

Other Identifiers

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SDR-KoBL

Identifier Type: -

Identifier Source: org_study_id

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