NCT01982721

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
12 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

1.9 years

First QC Date

October 30, 2013

Last Update Submit

March 30, 2016

Conditions

Transfemoral Amputees

Outcome Measures

Primary Outcomes (1)

  • 3D angles of the ankle, knee, hip and pelvis

    One day

Study Arms (2)

Transfemoral amputees

EXPERIMENTAL

Locking mechanism for prosthetic knee (no trade mark provided)

Device: Locking mechanism for prosthetic knee

Healthy volunteers

NO INTERVENTION

Interventions

Locking mechanism for prosthetic kneeDEVICE
Transfemoral amputees

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Central Study Contacts

Isabela Schwartz, MD

CONTACT

IsabellaS@hadassah.org.il

Sigal Portnoy, PhD

CONTACT

97225844492sigalp@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Rehabilitation Department

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 13, 2013

Study Start

November 1, 2014

Primary Completion

October 1, 2016

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

IL(1)