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

Transfemoral Amputees Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01982721
• Other study ID #: Roee_HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: October 30, 2013
• Last updated: March 30, 2016
• Start date: November 2014

Study information

• Verified date: March 2016
• Source: Hadassah Medical Organization
• Contact: Isabela Schwartz, MD
• Email: IsabellaS[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health - Director General
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Transfemoral Amputees

Intervention

Device:
• Locking mechanism for prosthetic knee

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Dr. Sigal Portnoy

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3D angles of the ankle, knee, hip and pelvis		One day	No