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

June 3, 2015 updated by: BioGaming Ltd.

A Prospective, Single Site, Single-arm Study Designed to Evaluate the Performance of the BioGaming Device (YuGo) in the Support of Physical Rehabilitation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of BioGaming YuGo activity movements which are clinician recognized rehabilitation movements.
Time Frame: Baseline procedure
Activity movements are assessed by independent clinicians.
Baseline procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Record of any adverse event
Time Frame: Baseline procedure
Any adverse event occurring during the baseline procedure will be recorded.
Baseline procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioGaming Ltd.

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

March 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

February 22, 2015

First Posted (Estimate)

February 27, 2015

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 111CLD

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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