Evaluation of Balance Reactions of Transfemoral Amputees... | NCT00817570

Studies
Evaluation of Balance Reactions of Transfemoral Amputees Using the Virtual Analysis System

NCT00817570

Sponsor

Sheba Medical Center

Status

Suspended

Last Update Posted

Oct 22, 2009Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Balance

Interventions

Not provided

Countries

Israel

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

Oct 2009

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 4, 2009

First Submission Date that Met QC Criteria

Jan 5, 2009

First Posted Date

Jan 6, 2009Estimated

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

Oct 21, 2009

Last Update Posted Date

Oct 22, 2009Estimated

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

The purpose of this study is to test and compare the balance reactions of Tranfemoral Amputees and able bodied subjects in response to perturbations given by a highly advanced Virtual Reality system.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Transfemoral Amputees using the C- Leg knee.
2		Transfemoral Amputees using a Multiaxial Knee.
3		Able bodied.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Transfemoral Amputees, walking without any assistive device, at least one year.

Exclusion Criteria:

Amputees who suffer from a Neurological Injury/ disease that has implication on balance control.
Amputees who suffer from Orthopedic Injury that has implication on balance control.
Amputees who suffer from Cardiology disease that has implication on balance reactions.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Transfemoral Amputees and Able bodied.

Sampling Method

Non-Probability Sample