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The Effect of Virtual Reality Exercises on Balance in Patients With Osteoporosis

Primary Purpose

Osteoporosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
Nigde Omer Halisdemir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Osteoporosis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Virtual Realty

    Arm Description

    Microsoft Xbox Kinect® was used for virtual reality exercises

    Outcomes

    Primary Outcome Measures

    Static balance index
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    September 30, 2020
    Last Updated
    March 1, 2021
    Sponsor
    Nigde Omer Halisdemir University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04780997
    Brief Title
    The Effect of Virtual Reality Exercises on Balance in Patients With Osteoporosis
    Official Title
    The Effect of Virtual Reality Exercises on Balance in Patients With Osteoporosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2021 (Anticipated)
    Primary Completion Date
    August 30, 2021 (Anticipated)
    Study Completion Date
    October 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nigde Omer Halisdemir University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Virtual Realty
    Arm Type
    Experimental
    Arm Description
    Microsoft Xbox Kinect® was used for virtual reality exercises
    Intervention Type
    Other
    Intervention Name(s)
    Virtual Reality
    Intervention Description
    Microsoft Xbox Kinect® was used for virtual reality exercises
    Primary Outcome Measure Information:
    Title
    Static balance index
    Description
    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
    Time Frame
    4th week

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Musa Polat
    Phone
    05058634671
    Email
    musa.polat.sfl@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Musa Polat
    Organizational Affiliation
    Niğde OHÜ
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effect of Virtual Reality Exercises on Balance in Patients With Osteoporosis

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