NCT03142087

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 21, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

March 31, 2017

Last Update Submit

January 4, 2018

Conditions

Keywords

balancebrain tumorvirtual reality

Outcome Measures

Primary Outcomes (1)

  • 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

    change from baseline balance at 8 weeks

Study Arms (2)

virtual reality exercises

ACTIVE COMPARATOR

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

conventional exercises

ACTIVE COMPARATOR

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

Interventions

exercise

conventional exercisesvirtual reality exercises

Eligibility Criteria

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

You may qualify if:

  • years of children
  • brain tumor

You may not qualify if:

  • have any conditions with exercises
  • neurological and musculoskeletal disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Müberra Tanrıverdi, PT, MSc

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer, PT, MSc, PhD (c)

Study Record Dates

First Submitted

March 31, 2017

First Posted

May 5, 2017

Study Start

March 21, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 5, 2018

Record last verified: 2018-01

Locations