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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04784026
Other study ID # 2021/144
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date March 20, 2023

Study information

Verified date March 2021
Source Afyonkarahisar Health Sciences University
Contact EMEL TASVURAN HORATA, PhD
Phone 05547759663
Email ethorata@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 20, 2023
Est. primary completion date March 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Gait assessment (single)
The single walk will be evaluated with a 10-meter walking test and a G-Walk portable device.
Dual task gait assessment (motor+motor)
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.
Dual tak gait assessment (motor+cognitive)
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.

Locations

Country Name City State
Turkey Emel Tasvuran Horata Afyonkarahisar

Sponsors (1)

Lead Sponsor Collaborator
Afyonkarahisar Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary gait speed Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance. 20 minutes
Primary cadence Cadence is the rate at which a person walk, expressed in steps per minute. The average cadence is 100 - 115 steps/min. 20 minutes
Primary stride length Stride length is defined as the distance between successive ground contacts of the same foot. 20 minutes
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