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

NCT ID: NCT01982721

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Brief Summary

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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

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Conditions

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Transfemoral Amputees

Study Groups

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Transfemoral amputees

Locking mechanism for prosthetic knee (no trade mark provided)

Group Type EXPERIMENTAL

Locking mechanism for prosthetic knee

Intervention Type DEVICE

Healthy volunteers

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Locking mechanism for prosthetic knee

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Sigal Portnoy

UNKNOWN

Sponsor Role collaborator

Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Isabella Shvartz

Head of Rehabilitation Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Isabela Schwartz, MD

Role: CONTACT

Sigal Portnoy, PhD

Role: CONTACT

97225844492

Facility Contacts

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Arik Tzukert, DMD

Role: primary

00 972 2 6776095

Hadas Lemberg, PhD

Role: backup

00 972 2 6777572

Other Identifiers

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Roee_HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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