- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04780997
The Effect of Virtual Reality Exercises on Balance in Patients With Osteoporosis
March 1, 2021 updated by: MUSA POLAT, Nigde Omer Halisdemir University
Osteoporosis is a systemic disease characterized by low bone mass and increased bone fragility and increased fracture likelihood as a result of deterioration of the bone tissue microstructure.One of the important conditions determining the fracture risk in osteoporosis patients is fall.
Balance exercises are perform to reduce the risk of falling.Virtual reality games are used in balance studies in many rehabilitation areas.
The aim of this study is to investigate the effect of virtual reality exercises on balance.
Study Overview
Detailed Description
Osteoporosis is a systemic disease characterized by low bone mass and increased bone fragility and increased fracture likelihood as a result of deterioration of the bone tissue microstructure.One of the important conditions determining the fracture risk in osteoporosis patients is fall.
Balance exercises are perform to reduce the risk of falling.Virtual reality games are used in balance studies in many rehabilitation areas.
The aim of this study is to investigate the effect of virtual reality exercises on balance patients with osteoporozis.
Study Type
Interventional
Enrollment (Anticipated)
20
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 Contact
- Name: Musa Polat
- Phone Number: 05058634671
- Email: musa.polat.sfl@gmail.com
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
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- diagnosed with primary osteoporosis
Exclusion Criteria:
- history of inflammatory rheumatic disease
- history of vestibular and cerebellar disease
- diseases affecting the central and peripheral nervous system (Parkinson's, stroke, ataxia, dementia, multiple sclerosis, peripheral neuropathy
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: SCREENING
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Virtual Realty
Microsoft Xbox Kinect® was used for virtual reality exercises
|
Microsoft Xbox Kinect® was used for virtual reality exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Static balance index
Time Frame: 4th week
|
Postural balance was measured using the Biodex Balance System (BBS) (Biodex Medical Systems, Shirley, NY), a movable balance platform that provides up to 20 of surface tilt in a 360 range of motion.
The platform is interfaced with computer software (Biodex, Version 3.1, Biodex Medical Systems) that enables the device to serve as an objective assessment of balance
|
4th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Musa Polat, Niğde OHÜ
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 (ANTICIPATED)
April 1, 2021
Primary Completion (ANTICIPATED)
August 30, 2021
Study Completion (ANTICIPATED)
October 1, 2021
Study Registration Dates
First Submitted
September 30, 2020
First Submitted That Met QC Criteria
March 1, 2021
First Posted (ACTUAL)
March 4, 2021
Study Record Updates
Last Update Posted (ACTUAL)
March 4, 2021
Last Update Submitted That Met QC Criteria
March 1, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NigdeOHU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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