NCT04784026

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

2.1 years

First QC Date

March 2, 2021

Last Update Submit

March 2, 2021

Conditions

Keywords

pediatricsneoplasmsgait

Outcome Measures

Primary Outcomes (3)

  • gait speed

    Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance.

    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.

    20 minutes

  • stride length

    Stride length is defined as the distance between successive ground contacts of the same foot.

    20 minutes

Study Arms (2)

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.

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.

Other: Gait assessment (single)Other: Dual task gait assessment (motor+motor)Other: Dual tak gait assessment (motor+cognitive)

Interventions

The single walk will be evaluated with a 10-meter walking test and a G-Walk portable device.

Case GroupHealthy Control Group

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.

Case GroupHealthy Control Group

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.

Case GroupHealthy Control Group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emel Taşvuran Horata

Afyonkarahisar, 03030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Single Person

Intervention Hierarchy (Ancestors)

Marital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Officials

  • EMEL TAŞVURAN HORATA, PhD

    Afyonkarahisar Health Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

EMEL TAŞVURAN HORATA, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD; Assistant Professor

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 5, 2021

Study Start

March 1, 2021

Primary Completion

March 20, 2023

Study Completion

March 20, 2023

Last Updated

March 5, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations