NCT02765438

Brief Summary

Balance disorders are sometimes treated with exercises performed on unbalanced surfaces. The "BOBO" system allows connection of a standing platform attached to any of these surfaces, to a screen, where the user can control games with his or her body movements. In this study, the lower limb muscle activity of healthy individuals will be monitored during different games in order to assert the the ability of each game in strengthening certain muscle groups.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Status
unknown

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

May 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

May 4, 2016

Last Update Submit

May 24, 2017

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Measuring the muscle activity using an Electromyography device

    The muscle activities of lower limb muscles using surface Electromyography device will be in units of volt.

    2 hours

Study Arms (1)

BOBO

EXPERIMENTAL

Playing with the "BOBO" system.

Device: BOBO

Interventions

BOBODEVICE

Each subject will play four games with the "BOBO" system.

BOBO

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Native Hebrew speaking

You may not qualify if:

  • Familiar with the "BOBO" system
  • Previous lower limb injuries
  • Have a pacemaker
  • Have neurological or vestibular deficiencies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Isabella Schwartz, MD

CONTACT

(972) -(0)2-5844474isabellas@hadassah.org.il

Hadas Lemberg, PhD

CONTACT

00 972 2 6777572lhadas@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 6, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2017

Last Updated

May 25, 2017

Record last verified: 2017-05