- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03344952
Improvement on GMFCS Level of Patients With Cerebral Palsy Treated by Repeated Botulinum Toxin-A
29. november 2018 opdateret af: Nigar Dursun, Kocaeli University
Long Term Improvement on GMFCS Level of Patients With Cerebral Palsy Treated by an Integrated Approach of Repeated Botulinum Toxin-A Injections
The aim of this retrospective, monocenter, observational study is to evaluate the changes in GMFCS levels of children with cerebral palsy (CP) who received repeated Botulinum Toxin-A (BoNT-A) injections in the lower limb(s) with an integrated treatment approach in Kocaeli University Department of PMR and Izmit Rehabilitation Center.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
It is generally agreed that children with CP reach their gross motor potential by the age of 3.5-5 and a child or young person over the age of 5 years will not improve their GMFCS level.
BoNT-A is an important treatment in children with CP because it is safe in young children and allows combined treatment.
The reduction in muscle tone by this selective treatment provides an opportunity to allow and optimize the effects of other treatments including orthoses, casting, conventional therapies and activity based functional trainings.
For this reason, BoNT-A injections are always combined with other therapies in Kocaeli University Department of PMR and Izmit Rehabilitation Center.
Adjunctive treatments in this department consists of serial casting, orthotics, physical therapy, occupational therapy, cognitive rehabilitation, special educational programs, non invasive brain stimulation with transcranial direct current, neurofeedback, biofeedback, electrical stimulation and other physical therapy modalities, activity based models including functional ambulatory training, constraint induced therapy, bilateral therapy, hippotherapy, music therapy by singing or playing percussive instruments or moving and dancing to music, and robotic rehabilitation.
Individualized intensive combined treatment plan was applied by an appropriate neurorehab team to each patient within the department as a half day or full day program usually for 3 weeks starting 1 week or 10 days after BONT-A injections.
In thıs retrospective, monocenter, observational study a software database program will be developed and all the present data about the demographic and clinic properties of the patients, all information about BoNT-A injections including safety and applied adjunctive treatments will be entered and reviewed.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
503
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Kocaeli, Kalkun, 41050
- Kocaeli University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
2 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
All children diagnosis of cerebral palsy with respect to Rosenbaum criteria having received at least 2 repeated BoNT-A injections to lower limb(s) as well as an integrated treatment approach (an intensive therapy protocol consisted of a half day or entire day program in Kocaeli University Department of PMR and Izmit Rehabilitation Center) within the last 10 years
Beskrivelse
Inclusion Criteria:
- All children with a diagnosis of cerebral palsy with respect to Rosenbaum criteria
- Children who received at least 2 repeated BoNT-A injections to lower limb(s) as well as an integrated treatment approach (an intensive therapy protocol consisted of a half day or entire day program in Kocaeli University Department of PMR and Izmit Rehabilitation Center) within the last 10 years
Exclusion Criteria:
- Children who did not receive repeated injections
- Children who did not receive an intensive therapy protocol
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Tilbagevirkende kraft
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Gross Motor Functional Classification System (GMFCS)
Tidsramme: 10 years
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Motor development
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10 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Modified Ashworth Scale (MAS)
Tidsramme: Before and 4-6 weeks after each injection
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Assessment of tone
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Before and 4-6 weeks after each injection
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Angle of catch (XV3) of Modified Tardieu Scale (MTS)
Tidsramme: Before and 4-6 weeks after each injection
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Assessment of spasticity
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Before and 4-6 weeks after each injection
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Observational Gait Scale (OGS)
Tidsramme: Before and 4-6 weeks after each injection
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OGS is a measurement tool for analysis of gait consisting of seven gait parameters with a total score of 20.
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Before and 4-6 weeks after each injection
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. november 2017
Primær færdiggørelse (Faktiske)
10. oktober 2018
Studieafslutning (Faktiske)
9. november 2018
Datoer for studieregistrering
Først indsendt
14. november 2017
Først indsendt, der opfyldte QC-kriterier
14. november 2017
Først opslået (Faktiske)
17. november 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. november 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. november 2018
Sidst verificeret
1. november 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Hjerneskade, kronisk
- Cerebral Parese
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Kolinerge midler
- Membrantransportmodulatorer
- Acetylcholin-frigivelseshæmmere
- Neuromuskulære midler
- Botulinum toksiner
- Botulinumtoksiner, type A
- abobotulinumtoxinA
Andre undersøgelses-id-numre
- KU GOKAEK 2017/90
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
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