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Performance of the BioGaming Device (YuGo) in the Support of Physical Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373748
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
BioGaming Ltd.

Brief Summary:
The purpose of this study is to evaluate the movements performed according to the BioGaming YuGo software, and verify that they are rehabilitation movements.

Condition or disease Intervention/treatment Phase
Physical Rehabilitation Device: BioGaming YuGo System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single Site, Single-arm Study Designed to Evaluate the Performance of the BioGaming Device (YuGo) in the Support of Physical Rehabilitation
Study Start Date : March 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BioGaming YuGo System Device: BioGaming YuGo System
Subjects will perform a customized training program predefined in the BioGaming YuGo system.




Primary Outcome Measures :
  1. Number of BioGaming YuGo activity movements which are clinician recognized rehabilitation movements. [ Time Frame: Baseline procedure ]
    Activity movements are assessed by independent clinicians.


Secondary Outcome Measures :
  1. Safety - Record of any adverse event [ Time Frame: Baseline procedure ]
    Any adverse event occurring during the baseline procedure will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The subject is willing to comply with protocol-specified evaluations
  • Subject signed informed consent

Exclusion Criteria:

  • Pregnant or nursing female subjects
  • Surgical procedures or injuries to the extremities that could potentially affect physical functions
  • Neurological and/or vestibular disease
  • Cognitive impairment
  • Subjects taking any prescribed drugs that could potentially affect physical function and balance

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): NCT02373748


Locations
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Israel
Rambam Medical Center
Haifa, Israel, 31096
Sponsors and Collaborators
BioGaming Ltd.
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Responsible Party: BioGaming Ltd.
ClinicalTrials.gov Identifier: NCT02373748    
Other Study ID Numbers: 111CLD
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015