Efficacy and Usability of the Cyberlegs++ (CLs++) Ortho-prosthesis Modules in Enabling and Enhancing Mobility in Trans-femoral Amputees
Sponsor study identifier
interventional
16
0 countries
N/A
Study Start
January 1, 2018
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Primary Completion
January 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The aim of the study is to assess the efficacy and the usability of the cyberlegs ++ ortho prosthesis to improve the mobility and the quality of life in transfemoral amputees . This research focusses on the physical and mental effort needed in locomotion-related tasks and human robot interaction in transfemoral amputees using a novel active prosthesis. This is an international project and foresees 2 clinical studies aimed at assessing the efficacy of the CLs++ modules in different settings. In this first clinical study, 16 patients with unilateral trans-femoral amputation, 8 at the Vrije Universiteit Brussel Department Human Physiology Research group (VUB-MFYS) and 8 at the Don Gnocchi Foundation, center of Florence.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 27, 2017
Actual (reported)December 19, 2017
Actual (reported)January 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 1, 2021
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Energy expenditure
oxygen uptake (ml.kg)/carbondioxide production (ml.kg)
through 6 minutes
6-Minute Walk Test (6MWT)
through 6 minutes
Timed Up & Go test
through 14 seconds
Sit to stand test
through 5 minutes
Slope walking
through 5 minutes
Borg scale-ratings of perceived exertion
minute 6
CLs ++ gait training
CLs++ gait training
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First Submitted
November 27, 2017
First Posted
December 19, 2017
Study Start
January 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 1, 2018
Progressive Muscle Relaxation Technique on Lower Limb Amputation
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 27, 2017
Record last verified: 2017-12
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Source: ClinicalTrials.gov.
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