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

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ClinicalTrials.gov Identifier: NCT03142087
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Müberra TANRIVERDİ, Bezmialem Vakif University

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.

Condition or disease Intervention/treatment Phase
Postural Balance Other: exercises Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Virtual Reality Exercises on Balance in Children With Brain Tumors
Actual Study Start Date : March 21, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6-18 years of children
  • brain tumor

Exclusion Criteria:

  • have any conditions with exercises
  • neurological and musculoskeletal disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142087


Locations
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Turkey
Bezmialem Vakıf University
Istanbul, Turkey
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
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Principal Investigator: Müberra Tanrıverdi, PT, MSc Bezmialem Vakif University

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Responsible Party: Müberra TANRIVERDİ, lecturer, PT, MSc, PhD (c), Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03142087     History of Changes
Other Study ID Numbers: mtanriverdi88
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Müberra TANRIVERDİ, Bezmialem Vakif University:
balance
brain tumor
virtual reality
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases