The Effect of Virtual Reality Exercises on Balance in Children With Brain Tumors

January 4, 2018 updated by: Müberra TANRIVERDİ, Bezmialem Vakif University
30 patients with brain tumor will be included in the study between the ages of 6 and 18 who have undergone surgery. Patients included in the study will be randomly assigned to two groups. The study group will be included in the Nintendo Wii Fit Plus Balance Game exercise program under the supervision of a physiotherapist for 2 days per week for 8 weeks. The control group will be taken to the conventional exercise program under the supervision of a physiotherapist for 2 days a week, 1 hour a day. The assessments will be made before the exercise program begins and at the end of the 8th week. Patients' physical measurements were assessed by anthropometric evaluations, muscle strength measurement, pain Visual Analogue Scale, walking Observational Walking Analysis, Balanced Pediatric Functional Range Test, Timed Up and Go (TUG) and one foot standing test and Nintendo Wii Fit Plus Balance Assessment, Functional capacity 2 min. With Walking Test, fatigue with PedsQL Multidimensional Fatigue Scale, daily life activities will be evaluated with WeeFIM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In our pediatric rehabilitation policlinic we have seen that these children has problems in balance and coordination from cause muscle weakness and cerebral-sensory-proprioceptive problems. We have evaluated with all parameters belong the physiotherapy and rehabilitation measurements and then planning this study with study protocol.

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

  • Turkey
      • Istanbul, Turkey
        • Bezmialem Vakıf University

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:

  • 6-18 years of children
  • brain tumor

Exclusion Criteria:

  • have any conditions with exercises
  • neurological and musculoskeletal disorders

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: virtual reality exercises
Nintendo Wii Fit Plus Game Console is used in these group. The one session included:warm-up exercises in 5-10 minutes, games (soccer heading, ski jump, ski slalom, etc.) in 30-40 minutes, and cooling exercises in 5 minutes.
Other: exercises
exercise
Active Comparator: conventional exercises
Physiotherapy and rehabilitation session included: warm-up exercises in 5-10 minutes, balance exercises (balance board, balance ball, two and one leg stand exercises, weight bearing exercises, balance in different type of surfaces, etc.) in 30-40 minutes, and cooling exercises in 5 minutes.
Other: exercises
exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effects of virtual reality exercises evaluating with Nintendo Wii Fit Plus on balance
Time Frame: change from baseline balance at 8 weeks
Nintendo Wii Fit Plus Game Console evaluation parameters which are percentage of weight bearing and central of gravity
change from baseline balance at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Principal Investigator: Müberra Tanrıverdi, PT, MSc, Bezmialem Vakif University

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)

March 21, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

March 31, 2017

First Submitted That Met QC Criteria

May 4, 2017

First Posted (Actual)

May 5, 2017

Study Record Updates

Last Update Posted (Actual)

January 5, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mtanriverdi88

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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