NCT02373748

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

3 months

First QC Date

February 17, 2015

Last Update Submit

June 3, 2015

Conditions

Physical Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Number of BioGaming YuGo activity movements which are clinician recognized rehabilitation movements.

    Activity movements are assessed by independent clinicians.

    Baseline procedure

Secondary Outcomes (1)

  • Safety - Record of any adverse event

    Baseline procedure

Study Arms (1)

BioGaming YuGo System

EXPERIMENTAL
Device: BioGaming YuGo System

Interventions

BioGaming YuGo SystemDEVICE

Subjects will perform a customized training program predefined in the BioGaming YuGo system.

BioGaming YuGo System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, 31096, Israel

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2015

First Posted

February 27, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations

IL(1)