CancerNCT05118464
Effect of Dual-Task Training on Pediatric Oncology Patients
A study testing Dual-task training in people with Cancer, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cancer
- What is being tested?
- Dual-task training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2021to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Emel Taşvuran Horata
Afyonkarahisar, 03030
EMEL TAŞVURAN HORATA, PhD, +905547759663, ethorata@gmail.com
ethorata@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Dual-task training
- Keywords
- cancer, gait, postural balance, muscle strength
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-task trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Children with cancer | Experimental | 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. Receives: Other: Dual-task training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 600 seconds
balance
Balance is evaluated with Timed-up and Go Test. The time elapsed during the test is recorded in seconds.
Measured: 300 seconds
Muscle strength
Isometric muscle strength will be evaluated with a hand-held dynamometer. It will be recorded in kg.
Measured: 600 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start15 Sep 2021
- Primary completion15 Sep 2022 (estimated)
- Study completion15 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Taşvuran Horata, Afyonkarahisar Health Sciences University
- Investigators
- EMEL TAŞVURAN HORATA, PhD, Principal investigator, AFSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118464
- Sponsor's protocol ID
- 2020/387
- Status last verified
- Nov 2021
- First submitted
- 31 Oct 2021
- Last updated
- 12 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Dual-Task Training on Muscle Strength, Balance, and Gait in Pediatric Oncology Patients
- ClinicalTrials.gov ID
- NCT05118464
- Acronym / sponsor ID
- 2020/387
- Conditions
- Cancer
- Keywords
- cancer, gait, postural balance, muscle strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 12 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with cancer | Experimental | Other: Dual-task trainingThe 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-task trainingDual-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. | Other | Children with cancer |
Primary outcome
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.
balance
Time frame: 300 seconds
Balance is evaluated with Timed-up and Go Test. The time elapsed during the test is recorded in seconds.
Muscle strength
Time frame: 600 seconds
Isometric muscle strength will be evaluated with a hand-held dynamometer. It will be recorded in kg.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMEL TAŞVURAN HORATA, PhD principal investigator
AFSU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-task training in people with Cancer, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact EMEL TAŞVURAN HORATA, PhD (+905547759663, ethorata@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait speed (time frame: 600 seconds). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2021.