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

Not Applicable

• Conditions: Transfemoral Amputees
• Interventions: Device: Locking mechanism for prosthetic knee

• Registration Number: NCT01982721
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-11-06
• Study First Posted: 2013-11-13
• Study Start: 2014-11
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-03-31
• Primary Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transfemoral amputees	Locking mechanism for prosthetic knee	Locking mechanism for prosthetic knee (no trade mark provided)

Primary Outcome Measures

Name	Time	Method
3D angles of the ankle, knee, hip and pelvis	One day

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel