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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01982721
Recruitment Status : Unknown
Verified March 2016 by Isabella Shvartz, Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : November 13, 2013
Last Update Posted : March 31, 2016
Dr. Sigal Portnoy
Information provided by (Responsible Party):
Isabella Shvartz, Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Transfemoral Amputees Device: Locking mechanism for prosthetic knee Not Applicable

Study Type : Interventional  (Clinical Trial)
Study Start Date : November 2014
Estimated Primary Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Transfemoral amputees
Locking mechanism for prosthetic knee (no trade mark provided)
Device: Locking mechanism for prosthetic knee
No Intervention: Healthy volunteers

Primary Outcome Measures :
  1. 3D angles of the ankle, knee, hip and pelvis [ Time Frame: One day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01982721

Contact: Isabela Schwartz, MD
Contact: Sigal Portnoy, PhD 97225844492

Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095   
Contact: Hadas Lemberg, PhD    00 972 2 6777572   
Sub-Investigator: Sigal Portnoy, Ph.D.         
Sponsors and Collaborators
Hadassah Medical Organization
Dr. Sigal Portnoy

Responsible Party: Isabella Shvartz, Head of Rehabilitation Department, Hadassah Medical Organization Identifier: NCT01982721     History of Changes
Other Study ID Numbers: Roee_HMO-CTIL
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016