Cerebral Palsy, SpasticNCT03179241
Outcome After Selective Dorsal Rhizothomy Concerning Life Quality, Cerebral Imaging and Cognition
An observational study of Cerebral Palsy, Spastic, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 2 to 25 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- 14 Oct 2017to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients treated with SDR at the Charité University clinics and who are able to perform tasks according to study protocols are eligible to enroll.
Who may be able to join
- clinical diagnosis of cerebral palsy
- able to perform most tasks according to study protocols
- parents and physician decided to perform SDR
Who cannot join
- not able to perform any tasks according to study protocols
- no candidate for SDR
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité University clinics
Berlin, 13353
Anne K van Riesen, MD, 0049 30 450 566 ext. 443, anne.van-riesen@charite.de
About this study
Official title: SDR-Auswertung, Unterteil Kognition, Bildgebung, Lebensqualität
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.
Read the 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.
- Conditions
- Cerebral Palsy, Spastic
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor function measured by GMFCS
Ability of a child to perform specified motor tasks, measured by GMFCS and GMFM-88
Measured: 5 years
Motor function measured by GMFM-88
Ability of a child to perform specified motor tasks, measured by GMFCS and GMFM-88
Measured: 5 years
Secondary outcomes (6)
Quality of life measured by "Disabkids"-Questionaire (German version)
Measured by "Disabkids"-Questionaire (German version) and "kid screen"
Measured: 5 years
Quality of life measured by questionaire "kid screen"
Measured by "kid screen"
Measured: 5 years
Selective motor control
Measured by SCALE (Fowler et al., 2009)
Measured: 5 years
Spasticity by modified Ashworth scale
Measured by modified Ashworth scale and Tardieu scale
Measured: 5 years
Spasticity by modified Tardieu scale
Measured by modified Ashworth scale and Tardieu scale
Measured: 5 years
Contractures by range of motion (ROM)
Measured by range of motion (ROM)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start14 Oct 2017
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne van Riesen, Charite University, Berlin, Germany
- Investigators
- Anne K van Riesen, M.D., Principal investigator, social pediatric center, departement of neuropediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179241
- Sponsor's protocol ID
- SDR-KoBL
- Status last verified
- Jul 2018
- First submitted
- 5 Jun 2017
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SDR-Auswertung, Unterteil Kognition, Bildgebung, Lebensqualität
- ClinicalTrials.gov ID
- NCT03179241
- Acronym / sponsor ID
- SDR-KoBL
- Conditions
- Cerebral Palsy, Spastic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 14 Oct 2017 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients treated with SDR at the Charité University clinics and who are able to perform tasks according to study protocols are eligible to enroll.
Key inclusion criteria (3 listed)
- clinical diagnosis of cerebral palsy
- able to perform most tasks according to study protocols
- parents and physician decided to perform SDR
Key exclusion criteria (2 listed)
- not able to perform any tasks according to study protocols
- no candidate for SDR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Motor function measured by GMFCS
Time frame: 5 years
Ability of a child to perform specified motor tasks, measured by GMFCS and GMFM-88
Motor function measured by GMFM-88
Time frame: 5 years
Ability of a child to perform specified motor tasks, measured by GMFCS and GMFM-88
6 secondary outcomes
Quality of life measured by "Disabkids"-Questionaire (German version)
Time frame: 5 years
Quality of life measured by questionaire "kid screen"
Time frame: 5 years
Selective motor control
Time frame: 5 years
Spasticity by modified Ashworth scale
Time frame: 5 years
Spasticity by modified Tardieu scale
Time frame: 5 years
Contractures by range of motion (ROM)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy, Spastic
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne K van Riesen, M.D. principal investigator
social pediatric center, departement of neuropediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, Spastic, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne K van Riesen, M.D. (+4930450666547, anne.van-riesen@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor function measured by GMFCS (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.