- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04784026
Dual Task Gait Performance in Pediatric Oncology Patients
Comparison of Single and Dual Task Gait Performance in Pediatric Oncology Patients With Healthy Control Group
Cancer incidence, which is recognized as the leading cause of death in children worldwide, is gradually increasing.
Most studies on children who survive cancer show that the disease and its treatment have side effects and long-term late effects on the musculoskeletal system, physical function, gait and cognitive skills.
Therefore, dual task gait performance, in which cognitive and motor tasks are performed simultaneously, may be affected in pediatric oncology patients. The aim of this study is to compare gait performance in single and dual task conditions in pediatric oncology patients with healthy controls.
Přehled studie
Postavení
Podmínky
Detailní popis
Cancer incidence, which is recognized as the leading cause of death in children worldwide, is gradually increasing. About 300,000 children aged 0 to 19 are diagnosed with cancer each year, according to the international study where the International Agency for Research on Cancer collected data on neoplasms (malignant and non-malignant) diagnosed in individuals under 20 years of age between 2001-2010.
Most studies on children who survive cancer show that the disease and its treatment have side effects and long-term late effects on the musculoskeletal system, physical function, gait and cognitive skills. According to the study of Beulertz et al. (2016), active ankle dorsiflexion limitation, gait disturbances and decrease in walking efficiency were observed in all pediatric oncology patients, which have an important role in walking, not limited to children with bone tumors and central nervous system tumors.Intensive chemotherapy (eg methotrexate) and the use of radiation are thought to cause damage to cortical and subcortical white matter, resulting in late effects. Symptoms consistent with attention deficit disorder and mental processing speed, working memory, executive function and memory deficits put cancer survivors at an intellectual and academic disadvantage.
Therefore, dual task gait performance, in which cognitive and motor tasks are performed simultaneously, may be affected in pediatric oncology patients. The aim of this study is to compare gait performance in single and dual task conditions in pediatric oncology patients with healthy controls.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní kontakt
- Jméno: EMEL TAŞVURAN HORATA, PhD
- Telefonní číslo: 05547759663
- E-mail: ethorata@gmail.com
Studijní místa
-
-
-
Afyonkarahisar, Krocan, 03030
- Nábor
- Emel Taşvuran Horata
-
Kontakt:
- Emel TAŞVURAN HORATA, PhD
- Telefonní číslo: +905547759663
- E-mail: ethorata@gmail.com
-
Kontakt:
- E-mail: ethorata@gmail.com
-
Vrchní vyšetřovatel:
- EMEL TAŞVURAN HORATA, PhD
-
Dílčí vyšetřovatel:
- Hamide Nur ÇEVİK ÖZDEMİR, PhD
-
Dílčí vyšetřovatel:
- Yunus Emre KUNDAKCI, PhD
-
Dílčí vyšetřovatel:
- İbrahim EKER, PhD
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
In this study, inpatient and outpatient children diagnosed with cancer in Afyonkarahisar Health Sciences University Health Application and Research Center Pediatric Hematology-Oncology Clinics will form the case group of the study.
Healthy children who come to Afyonkarahisar Ege Youth and Sports Club Association to do sports and who have recently registered will form the control group of the research.
Popis
Inclusion Criteria:
Healthy control group:
- Being in the age range of 6-18,
- To be physically, cognitively and mentally healthy,
- Open to communication enough to understand questions,
- Speaking and understanding Turkish,
- Approval has been obtained from the child and his / her family for the study and who agrees to participate in the study,
Case group:
- Able to walk alone without any walking aid,
- Open to communication enough to understand questions,
- Speaking and understanding Turkish,
- Approval has been obtained from the child and his / her family for the study and who agrees to participate in the study,
- Children between the ages of 6-18 will be included in the study
Exclusion Criteria:
Healthy control group:
- Any orthopedic or neurological impairment that would prevent walking;
- Having any mental disability that prevents cognitive task
Case group:
- Staying in an isolated room or having risk of infection (neutropenic, etc.),
- Any orthopedic or neurological impairment that could prevent walking;
- Having any mental disability that prevents cognitive task,
- Individuals with malignant hypertension or unstable heart disease (eg congestive heart failure) will not be included in the study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Case-Control
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Healthy Control Group
Healthy children who come to Afyonkarahisar Ege Youth and Sports Club Association for the purpose of sports, newly registered and between the ages of 6-18 will constitute the control group of the study.
|
The single walk will be evaluated with a 10-meter walking test and a G-Walk portable device.
The dual task gait, 10-meter walking test and a motor (carrying a full water glass) will be combined with the task and evaluated with the G-Walk portable device.
The dual task gait will be combined with a 10-meter walking test and a cognitive (1-back test) task and evaluated with the G-Walk portable device.
|
|
Case Group
The sample of the study will be inpatient and outpatient pediatric patients between the ages of 6-18 who have been diagnosed with cancer in the Pediatric Hematology-Oncology Clinics of Afyonkarahisar Health Sciences University Health Application and Research Center Department of Pediatrics.
|
The single walk will be evaluated with a 10-meter walking test and a G-Walk portable device.
The dual task gait, 10-meter walking test and a motor (carrying a full water glass) will be combined with the task and evaluated with the G-Walk portable device.
The dual task gait will be combined with a 10-meter walking test and a cognitive (1-back test) task and evaluated with the G-Walk portable device.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
gait speed
Časové okno: 20 minutes
|
Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance.
|
20 minutes
|
|
cadence
Časové okno: 20 minutes
|
Cadence is the rate at which a person walk, expressed in steps per minute.
The average cadence is 100 - 115 steps/min.
|
20 minutes
|
|
stride length
Časové okno: 20 minutes
|
Stride length is defined as the distance between successive ground contacts of the same foot.
|
20 minutes
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Emel TAŞVURAN HORATA, PhD, Afyonkarahisar Health Science University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Gait assessment (single)
-
Hana HaltmarDokončeno
-
Burcin CelikOndokuz Mayıs UniversityZatím nenabírámeChronická obstrukční plicní nemoc (CHOPN)
-
Hasselt UniversityJessa HospitalNáborMrtvice | Mrtvice s hemiparézouBelgie
-
MultiCare Health System Research InstituteNational Institute on Aging (NIA)Dokončeno
-
Lite Run Inc.Minneapolis Veterans Affairs Medical Center; TREATNeznámýMrtvice | Poranění mozku, traumatické | Poranění míchy | Poruchy chůze, neurologické
-
University of Wisconsin, MadisonNational Institute on Aging (NIA)Zatím nenabíráme
-
Lithuanian University of Health SciencesNáborIschemie mozku | Cévní mozková příhoda, ischemickáLitva
-
University of WolverhamptonThe Royal Wolverhampton Hospitals NHS TrustNáborPokročilý karcinom prostatySpojené království
-
Maastricht University Medical CenterNábor
-
Alzheimer's Light LLCNáborRoztroušená skleróza | Parkinsonova choroba | Alzheimerova nemoc | Mírná kognitivní porucha | Frontotemporální demence | Vaskulární demence | TBISpojené státy