- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: EMEL TAŞVURAN HORATA, PhD
- Telefoonnummer: 05547759663
- E-mail: ethorata@gmail.com
Studie Locaties
-
-
-
Afyonkarahisar, Kalkoen, 03030
- Werving
- Emel Taşvuran Horata
-
Contact:
- Emel TAŞVURAN HORATA, PhD
- Telefoonnummer: +905547759663
- E-mail: ethorata@gmail.com
-
Contact:
- E-mail: ethorata@gmail.com
-
Hoofdonderzoeker:
- EMEL TAŞVURAN HORATA, PhD
-
Onderonderzoeker:
- Hamide Nur ÇEVİK ÖZDEMİR, PhD
-
Onderonderzoeker:
- Yunus Emre KUNDAKCI, PhD
-
Onderonderzoeker:
- İbrahim EKER, PhD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Case-control
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
gait speed
Tijdsspanne: 20 minutes
|
Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance.
|
20 minutes
|
|
cadence
Tijdsspanne: 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
Tijdsspanne: 20 minutes
|
Stride length is defined as the distance between successive ground contacts of the same foot.
|
20 minutes
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Emel TAŞVURAN HORATA, PhD, Afyonkarahisar Health Science University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 2021/144
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .