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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03142087
Other study ID # mtanriverdi88
Secondary ID
Status Completed
Phase N/A
First received March 31, 2017
Last updated January 4, 2018
Start date March 21, 2017
Est. completion date January 1, 2018

Study information

Verified date January 2018
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 1, 2018
Est. primary completion date January 1, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria:

- 6-18 years of children

- brain tumor

Exclusion Criteria:

- have any conditions with exercises

- neurological and musculoskeletal disorders

Study Design


Related Conditions & MeSH terms


Intervention

Other:
exercises
exercise

Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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