- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: EMEL TAŞVURAN HORATA, PhD
- Phone Number: 05547759663
- Email: ethorata@gmail.com
Study Locations
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-
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Afyonkarahisar, Turkey, 03030
- Recruiting
- Emel Taşvuran Horata
-
Contact:
- Emel TAŞVURAN HORATA, PhD
- Phone Number: +905547759663
- Email: ethorata@gmail.com
-
Contact:
- Email: ethorata@gmail.com
-
Principal Investigator:
- EMEL TAŞVURAN HORATA, PhD
-
Sub-Investigator:
- Hamide Nur ÇEVİK ÖZDEMİR, PhD
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Sub-Investigator:
- Yunus Emre KUNDAKCI, PhD
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Sub-Investigator:
- İbrahim EKER, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
gait speed
Time Frame: 20 minutes
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Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance.
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20 minutes
|
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cadence
Time Frame: 20 minutes
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Cadence is the rate at which a person walk, expressed in steps per minute.
The average cadence is 100 - 115 steps/min.
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20 minutes
|
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stride length
Time Frame: 20 minutes
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Stride length is defined as the distance between successive ground contacts of the same foot.
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20 minutes
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Collaborators and Investigators
Investigators
- Principal Investigator: Emel TAŞVURAN HORATA, PhD, Afyonkarahisar Health Science University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021/144
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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