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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05118464
Other study ID # 2020/387
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2021
Est. completion date September 15, 2023

Study information

Verified date November 2021
Source Afyonkarahisar Health Sciences University
Contact EMEL TASVURAN HORATA, PhD
Phone +905547759663
Email ethorata@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It is known that the treatment of children with cancer has negative effects on cognition, muscle strength, balance, and gait. Therefore, the aim of this study is to evaluate the effects of dual-task training, which is based on the principle of simultaneous performance of cognitive tasks and motor tasks, on muscle strength, balance, and gait.


Description:

With the increase in the incidence of cancer, the number of children who survived cancer is also increasing. Most studies on cancer survivors show that the disease and its treatment have side effects and long-term late effects on the musculoskeletal system, physical function, motor, and cognitive skills. Therefore, the aim of this study is to evaluate the effects of dual-task training, which is based on the principle of simultaneous performance of cognitive tasks and motor tasks, on muscle strength, balance, and gait. This study is planned to be the first study in which dual-task training is applied in children with cancer.


Recruitment information / eligibility

Status Recruiting
Enrollment 21
Est. completion date September 15, 2023
Est. primary completion date September 15, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: - Diagnosed with pediatric cancer and inpatient and outpatient treatment in Hematology-Oncology Clinics for treatment, - Able to walk alone without any walking aid, - Children aged 6-18 will be included Exclusion Criteria: - Staying in an isolated room or at risk of infection (neutropenic, etc.), - Any orthopedic or neurological disorder that may prevent walking; - Having any mental disability that will prevent performing a 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:
Dual-task training
Dual-task training includes simultaneous execution of motor and cognitive tasks. The motor tasks in this study will be walking, going up and downstairs, turning, throwing, and holding a ball. Cognitive tasks will be an n-back test, verbal fluency, remembering sequences of numbers, and performing simple summing.

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. It will be recorded in m/s. 600 seconds
Primary balance Balance is evaluated with Timed-up and Go Test. The time elapsed during the test is recorded in seconds. 300 seconds
Primary Muscle strength Isometric muscle strength will be evaluated with a hand-held dynamometer. It will be recorded in kg. 600 seconds
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