Pediatric CancerNCT04784026
Dual Task Gait Performance in Pediatric Oncology Patients
An observational study of Pediatric Cancer, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Gait assessment (single), Dual task gait assessment (motor+motor) and Dual tak gait assessment (motor+cognitive)
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 20 Mar 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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,
Show all 12Show fewer
- 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
Who cannot join
- 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.
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: 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.
Read the 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.
- Conditions
- Pediatric Cancer
- Being tested
- Gait assessment (single), Dual task gait assessment (motor+motor), Dual tak gait assessment (motor+cognitive)
- Keywords
- pediatrics, neoplasms, gait
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait assessment (single)Other
The single walk will be evaluated with a 10-meter walking test and a G-Walk portable device.
Dual task gait assessment (motor+motor)Other
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Gait assessment (single); Other: Dual task gait assessment (motor+motor); Other: Dual tak gait assessment (motor+cognitive) | |
| 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. Receives: Other: Gait assessment (single); Other: Dual task gait assessment (motor+motor); Other: Dual tak gait assessment (motor+cognitive) |
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.
Measured: 20 minutes
cadence
Cadence is the rate at which a person walk, expressed in steps per minute. The average cadence is 100 - 115 steps/min.
Measured: 20 minutes
stride length
Stride length is defined as the distance between successive ground contacts of the same foot.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Mar 2021
- Primary completion20 Mar 2023 (estimated)
- Study completion20 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 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, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784026
- Sponsor's protocol ID
- 2021/144
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 5 Mar 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 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single and Dual Task Gait Performance in Pediatric Oncology Patients With Healthy Control Group
- ClinicalTrials.gov ID
- NCT04784026
- Acronym / sponsor ID
- 2021/144
- Conditions
- Pediatric Cancer
- Keywords
- pediatrics, neoplasms, gait
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 20 Mar 2023 (estimated)
- Study completion
- 20 Mar 2023 (estimated)
- First posted
- 5 Mar 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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Group | – | Other: Gait assessment (single), Other: Dual task gait assessment (motor+motor), Other: Dual tak gait assessment (motor+cognitive)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. |
| Case Group | – | Other: Gait assessment (single), Other: Dual task gait assessment (motor+motor), Other: Dual tak gait assessment (motor+cognitive)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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (12 listed)
- 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,
Key exclusion criteria (8 listed)
- Any orthopedic or neurological impairment that would prevent walking;
- Having any mental disability that prevents cognitive task
- 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,
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 |
|---|---|---|
| Gait assessment (single)The single walk will be evaluated with a 10-meter walking test and a G-Walk portable device. | Other | Case Group, Healthy Control Group |
| 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. | Other | Case Group, Healthy Control Group |
| 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. | Other | Case Group, Healthy Control Group |
Primary outcome
gait speed
Time frame: 20 minutes
Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance.
cadence
Time frame: 20 minutes
Cadence is the rate at which a person walk, expressed in steps per minute. The average cadence is 100 - 115 steps/min.
stride length
Time frame: 20 minutes
Stride length is defined as the distance between successive ground contacts of the same foot.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 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
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric 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 12 inclusion and 8 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 5 Mar 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 (05547759663, 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: 20 minutes). 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 5 Mar 2021.