Gait Evaluation of Experienced Below Knee Amputees | NCT00353626

Studies
Gait Evaluation of Experienced Below Knee Amputees

NCT00353626

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

Mar 24, 2008Estimated

Enrollment

9Actual

Phase

Not provided

Conditions

Amputations, Traumatic

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

Mar 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Jul 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Jul 16, 2006

First Submission Date that Met QC Criteria

Jul 16, 2006

First Posted Date

Jul 18, 2006Estimated

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

Mar 19, 2008

Last Update Posted Date

Mar 24, 2008Estimated

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

Post traumatic amputees with an experience of over 3 months of prosthesis use at home, without any known difficulty using the prosthesis and without stump pathology, using no assistive devices, will be examined in a 3 D computerized gait laboratory. Kinematic and kinetic parameters of gait will be obtained.

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

9Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Post traumatic trans tibial amputees
No stump pathology
No assistive devices
No technical difficulty

Exclusion Criteria:

Vascular or DM background
Stump pathology
Gait difficulties
Assistive device

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Trans tibial amputees without pain or complaints about stump or prosthesis,using their prosthesis more than 3 months.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Uri Givon, MD	Motion analysis Laboratory, Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Tel Litwinsky		71908	Israel