Lower Limb Muscle Activity With "BOBO" | NCT02765438

Studies
Lower Limb Muscle Activity With "BOBO"

NCT02765438

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

May 25, 2017Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Healthy Volunteers

Interventions

BOBO

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Aug 2017Estimated

Completion Date

Not provided

First Submitted Date

May 4, 2016

First Submission Date that Met QC Criteria

May 5, 2016

First Posted Date

May 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2017

Last Update Posted Date

May 25, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Healthy subject will fill out a demographic questionnaire following the exercise they will fill out a subjective questionnaire for assessment of the exercise. Each subject will play 4 games using the "BOBO" while surface electrodes are placed on the gluteus max/medius, quadriceps, hamstring, peroneal ,tibialis anterior, gastrocnemius.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BOBO	Experimental	Playing with the "BOBO" system.	Device: BOBO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BOBO	Device	Each subject will play four games with the "BOBO" system.	BOBO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Native Hebrew speaking

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Isabella Schwartz, MD	Contact	(972) -(0)2-5844474		isabellas@hadassah.org.il
Hadas Lemberg, PhD	Contact	00 972 2 6777572		lhadas@hadassah.org.il

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided