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

Physical Rehabilitation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373748
• Other study ID #: 111CLD
• Status: Completed
• Phase: N/A
• First received: February 17, 2015
• Last updated: June 3, 2015
• Start date: March 2015
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: BioGaming Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Physical Rehabilitation

Intervention

Device:
• BioGaming YuGo System
Subjects will perform a customized training program predefined in the BioGaming YuGo system.

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
BioGaming Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of BioGaming YuGo activity movements which are clinician recognized rehabilitation movements.	Activity movements are assessed by independent clinicians.	Baseline procedure	No
Secondary	Safety - Record of any adverse event	Any adverse event occurring during the baseline procedure will be recorded.	Baseline procedure	Yes