- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05118464
Effect of Dual-Task Training on Pediatric Oncology Patients
November 11, 2021 updated by: Emel Taşvuran Horata, Afyonkarahisar Health Sciences University
Evaluation of the Effect of Dual-Task Training on Muscle Strength, Balance, and Gait in Pediatric Oncology Patients
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Emel TAŞVURAN HORATA, PhD
- Phone Number: +905547759663
- Email: ethorata@gmail.com
Study Locations
-
-
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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:
- İbrahim EKER, PhD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Children with cancer
The arm of the research will consist of pediatric patients aged 6-18 years who have been diagnosed with cancer in Afyonkarahisar Health Sciences University, Health Application and Research Center, Department of Pediatric Hematology-Oncology Clinics and who come for outpatient treatment.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
gait speed
Time Frame: 600 seconds
|
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
|
|
balance
Time Frame: 300 seconds
|
Balance is evaluated with Timed-up and Go Test.
The time elapsed during the test is recorded in seconds.
|
300 seconds
|
|
Muscle strength
Time Frame: 600 seconds
|
Isometric muscle strength will be evaluated with a hand-held dynamometer.
It will be recorded in kg.
|
600 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: EMEL TAŞVURAN HORATA, PhD, AFSU
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2021
Primary Completion (Anticipated)
September 15, 2022
Study Completion (Anticipated)
September 15, 2023
Study Registration Dates
First Submitted
October 31, 2021
First Submitted That Met QC Criteria
November 11, 2021
First Posted (Actual)
November 12, 2021
Study Record Updates
Last Update Posted (Actual)
November 12, 2021
Last Update Submitted That Met QC Criteria
November 11, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020/387
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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