Trial record 2 of 29 for:    Open 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. (see Contacts and Locations)
Verified November 2013 by Hadassah Medical Organization
Sponsor:
Collaborator:
Dr. Sigal Portnoy
Information provided by (Responsible Party):
Isabella Shvartz, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01982721
First received: October 30, 2013
Last updated: November 6, 2013
Last verified: November 2013
  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 Hadassah Medical Organization:

Primary Outcome Measures:
  • 3D angles of the ankle, knee, hip and pelvis [ Time Frame: One day ] [ Designated as safety issue: No ]

Study Start Date: November 2014
Estimated Primary Completion Date: October 2015 (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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 30, 2013
Last Updated: November 6, 2013
Health Authority: Israel: Ministry of Health - Director General

ClinicalTrials.gov processed this record on October 29, 2014