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Trial record 2 of 38 for:    Recruiting, Not yet recruiting, Available Studies | "Amputees"

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

This study is not yet open for participant recruitment.
Verified March 2016 by Isabella Shvartz, Hadassah Medical Organization
Sponsor:
ClinicalTrials.gov Identifier:
NCT01982721
First Posted: November 13, 2013
Last Update Posted: March 31, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Dr. Sigal Portnoy
Information provided by (Responsible Party):
Isabella Shvartz, Hadassah Medical Organization
  Purpose
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 Intervention
Transfemoral Amputees Device: Locking mechanism for prosthetic knee

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Isabella Shvartz, Hadassah Medical Organization:

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

Study Start Date: November 2014
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transfemoral amputees
Locking mechanism for prosthetic knee (no trade mark provided)
Device: Locking mechanism for prosthetic knee
No Intervention: Healthy volunteers

  Eligibility

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01982721


Contacts
Contact: Isabela Schwartz, MD IsabellaS@hadassah.org.il
Contact: Sigal Portnoy, PhD 97225844492 sigalp@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Sub-Investigator: Sigal Portnoy, Ph.D.         
Sponsors and Collaborators
Hadassah Medical Organization
Dr. Sigal Portnoy
  More Information

Responsible Party: Isabella Shvartz, Head of Rehabilitation Department, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01982721     History of Changes
Other Study ID Numbers: Roee_HMO-CTIL
First Submitted: October 30, 2013
First Posted: November 13, 2013
Last Update Posted: March 31, 2016
Last Verified: March 2016