NCT05118464

Brief 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.

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
21

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Sep 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 12, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

November 12, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

October 31, 2021

Last Update Submit

November 11, 2021

Conditions

Keywords

cancergaitpostural balancemuscle strength

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. It will be recorded in m/s.

    600 seconds

  • balance

    Balance is evaluated with Timed-up and Go Test. The time elapsed during the test is recorded in seconds.

    300 seconds

  • Muscle strength

    Isometric muscle strength will be evaluated with a hand-held dynamometer. It will be recorded in kg.

    600 seconds

Study Arms (1)

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.

Other: Dual-task training

Interventions

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.

Children with cancer

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emel Taşvuran Horata

Afyonkarahisar, 03030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • EMEL TAŞVURAN HORATA, PhD

    AFSU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

EMEL TAŞVURAN HORATA, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD; Assistant Professor

Study Record Dates

First Submitted

October 31, 2021

First Posted

November 12, 2021

Study Start

September 15, 2021

Primary Completion

September 15, 2022

Study Completion

September 15, 2023

Last Updated

November 12, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations