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

Primary Purpose

Postural Balance

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

exercises

About this trial

This is an interventional treatment trial for Postural Balance focused on measuring balance, brain tumor, virtual reality

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

6-18 years of children
brain tumor

Exclusion Criteria:

have any conditions with exercises
neurological and musculoskeletal disorders

Sites / Locations

Bezmialem Vakıf University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

virtual reality exercises

conventional exercises

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

the effects of virtual reality exercises evaluating with Nintendo Wii Fit Plus on balance

Nintendo Wii Fit Plus Game Console evaluation parameters which are percentage of weight bearing and central of gravity

Secondary Outcome Measures

Full Information

NCT ID

NCT03142087

First Posted

March 31, 2017

Last Updated

January 4, 2018

Sponsor

Bezmialem Vakif University

1. Study Identification

Unique Protocol Identification Number

NCT03142087

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

March 21, 2017 (Actual)

Primary Completion Date

January 1, 2018 (Actual)

Study Completion Date

January 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postural Balance

Keywords

balance, brain tumor, virtual reality

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

virtual reality exercises

Arm Type

Active Comparator

Arm Description

Arm Title

conventional exercises

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

exercises

Intervention Description

exercise

Primary Outcome Measure Information:

Title

the effects of virtual reality exercises evaluating with Nintendo Wii Fit Plus on balance

Description

Nintendo Wii Fit Plus Game Console evaluation parameters which are percentage of weight bearing and central of gravity

Time Frame

change from baseline balance at 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 6-18 years of children brain tumor Exclusion Criteria: have any conditions with exercises neurological and musculoskeletal disorders

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Müberra Tanrıverdi, PT, MSc

Organizational Affiliation

Bezmialem Vakif University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bezmialem Vakıf University

City

Istanbul

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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