- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01982721
Evaluation of an Acceleration-Based Prosthetic Knee Locking Mechanism for Reducing the Risk of Falling in Transfemoral Amputees
March 30, 2016 updated by: Isabella Shvartz, Hadassah Medical Organization
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jerusalem, Israel
- Hadassah Medical Organization
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transfemoral amputees
Locking mechanism for prosthetic knee (no trade mark provided)
|
|
No Intervention: Healthy volunteers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
3D angles of the ankle, knee, hip and pelvis
Time Frame: One day
|
One day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Anticipated)
October 1, 2016
Study Registration Dates
First Submitted
October 30, 2013
First Submitted That Met QC Criteria
November 6, 2013
First Posted (Estimate)
November 13, 2013
Study Record Updates
Last Update Posted (Estimate)
March 31, 2016
Last Update Submitted That Met QC Criteria
March 30, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- Roee_HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Transfemoral Amputees
-
Shirley Ryan AbilityLabActive, not recruitingTransfemoral AmputeesUnited States
-
Shirley Ryan AbilityLabCompletedTransfemoral AmputeesUnited States
-
University of South FloridaSouthern Bone & Joint Specialists, P.A.CompletedSocket Designs of Transfemoral Amputees.United States
-
Sultan Abdulhamid Han Training and Research Hospital...CompletedTransfemoral Amputees | Kinesiology TapingTurkey
-
University of WashingtonÖssur EhfCompletedTransfemoral AmputationUnited States
-
Hadassah Medical OrganizationTel Aviv UniversityUnknown
-
Southern California Institute for Research and...CompletedUnilateral Transfemoral AmputationUnited States
-
Henry M. Jackson Foundation for the Advancement...University of Miami; Walter Reed National Military Medical Center; Uniformed... and other collaboratorsUnknownTranstibial Amputation | Transfemoral AmputationUnited States
-
University of DelawareTerminated
-
Heidelberg UniversityCNSystems Medizintechnik AGCompleted
Clinical Trials on Locking mechanism for prosthetic knee
-
Orthocare Innovations, LLCEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingMovement Disorders | Limb Loss | Limb Weakness | Limb ParalysisUnited States
-
VA Office of Research and DevelopmentRecruitingTransfemoral Amputation | Limb Loss | Limb AbsenceUnited States
-
Georgia Institute of TechnologyCompleted
-
Methodist Rehabilitation CenterÖssur EhfCompletedAmputation of Lower Limb Above Knee
-
GCS Ramsay Santé pour l'Enseignement et la RechercheRecruitingUnilateral Primary Osteoarthritis of KneeFrance
-
Xiaoxiao ZhouCompletedHumeral Fracture, Proximal | Internal Fixation; Complications, Mechanical, Bones of Limb
-
Helsinki University Central HospitalCompletedAmputation StumpFinland
-
Ohio Willow WoodOhio State UniversityUnknown
-
Borja Alcobía-Díaz MD, PhDRecruitingClinical and Radiological Results in Robotic Assisted Knee Prosthetic Surgery With ROSA® Knee SystemKnee Prosthetic Surgery | Robotic AssistanceSpain
-
Central Hospital, Nancy, FranceEnrolling by invitationShoulder DiseaseFrance