Evaluation of an Acceleration-Based Prosthetic Knee Locki... | NCT01982721

Studies
Evaluation of an Acceleration-Based Prosthetic Knee Locking Mechanism for Reducing the Risk of Falling in Transfemoral Amputees

NCT01982721

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Mar 31, 2016Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Transfemoral Amputees

Interventions

Locking mechanism for prosthetic knee

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 2016

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

Nov 2014

Primary Completion Date

Oct 2016Estimated

Completion Date

Not provided

First Submitted Date

Oct 30, 2013

First Submission Date that Met QC Criteria

Nov 6, 2013

First Posted Date

Nov 13, 2013Estimated

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 30, 2016

Last Update Posted Date

Mar 31, 2016Estimated

Name	Class
Dr. Sigal Portnoy	UNKNOWN

Description Module

Brief Summary

The investigators hypothesize that a new automatic prosthetic knee locking mechanism will improve gait characteristics during an induced controlled trip and reduce fear of falling.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transfemoral amputees	Experimental	Locking mechanism for prosthetic knee (no trade mark provided)	Device: Locking mechanism for prosthetic knee
Healthy volunteers	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Locking mechanism for prosthetic knee	Device		Transfemoral amputees

Measure	Description	Time Frame
3D angles of the ankle, knee, hip and pelvis		One day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

transfemoral amputees
Independent ambulation with a prosthesis
Full cognitive and cooperative ability to follow simple instructions
No orthopaedic or neurologic impairments present, that are unrelated to the amputation at the time of the trial

Exclusion Criteria:

Cognitive disorders preventing the subject from understanding the trial protocol, signing a consent form or following the researcher's instructions
Orthopaedic or neurologic impairment, un-related to the amputation
Pregnant woman
Weight exceeding 100 kg

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Isabela Schwartz, MD	Contact			IsabellaS@hadassah.org.il
Sigal Portnoy, PhD	Contact	97225844492		sigalp@hadassah.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem			Israel