NCT04129853|UnknownDMC
The CYBERnetic LowEr Imb coGnitive Ortho-prostheis Plus Plus, 2nd Clinical Study (CLs++)
The Efficacy of the Cyberlegs Xleg During Daily Activities in People With a Unilateral Lower Limb Amputation
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The Efficacy of the Cyberlegs Xleg During Daily Activities in People With a Unilateral Lower Limb Amputation
Sponsor study identifier
interventional
14
1 country
1
Study Start
January 2, 2020
Actual (reported)Primary Completion
August 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The aim of the project is to evaluate the efficacy of the Cyberlegs X-leg in people with a unilateral transfemoral (above the knee joint) and transtibial (under the knee joint) amputation. De Cyberlegs X-leg is in continuation of the development of the Cyberlegs gamma-prototype (B.U.N. 143201732970; FAMHP reference number: 80M0725). The Cyberlegs X-leg is a motorized prosthesis which replaces the amputated part of the leg. Our hypothesis is that people with a lower limb amputation perform daily activities (e.g. walking, stair climbing, sit to stand, et cetera) easier, more comfortable and more efficient with the X-leg compared to their current prosthesis. Assessments will be based on a holistic approach in which biomechanical, physiological and psychological parameters are determined.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 11, 2019
Actual (reported)October 17, 2019
Actual (reported)January 2, 2020
Actual (reported)August 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Physical performance determinant
duration of the different tests (sec) measured with a chronometer.
1 year
Physical performance determinant
number of stands during the sit to stand test (number)
1 year
Physical performance determinant
normal walking speed (m/sec)
1 year
Biomechanical outcome measure
joint angels (degrees) of flexion and extension of the knee and ankle joint.
1 year
Biomechanical outcome measure
pressure plots of both the amputated and sound foot (N/m²)
1 year
Biomechanical outcome measure
Performing a sit to stand with the Cyberlegs Xleg and comparing with their current prosthesis.
Comparing the cyberlegs xleg with other devices.
Sit to stand, Stair Climbing, Slope walking, L-test, Hallway walking with the current vs. cyberlegs xleg and cyberlegs vs power knee
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Vrije Universiteit Brussel
Brussels, 1050, Belgium
First Submitted
October 11, 2019
First Posted
October 17, 2019
Study Start
January 2, 2020
Actual (reported)Primary Completion
August 1, 2020
Estimated (date passed)Progressive Muscle Relaxation Technique on Lower Limb Amputation
cadence during the hallway walking test (steps/mine)
1 year
Biomechanical outcome measure
step width (cm)
1 year
Biomechanical outcome measure
step length (cm)
1 year
Biomechanical outcome measure
swing phases in % of gait cycle
1 year
Biomechanical outcome measure
stance phases in % of gait cycle
1 year
Electrohysiological outcome measure
heart rate (bpm)
1 year
Physiological outcome measure
oxygen uptake (ml/min)
1 year
Physiological outcome measure
carbon dioxide production (ml/min)
1 year
Physiological outcome measure
ventilation (L/min)
1 year
Electrohysiological outcome measure
electrocardiogram
1 year
Electrohysiological outcome measure
skin temperature (degees celcius)
1 year
Electrohysiological outcome measure
muscle activity during different movements (% of the MVC)
1 year
Psychological outcome measure
rating of perceived exertion (arbitrary valu between 0 and 10)
1 year
Psychological outcome measure
the visual analogue scale (arbitrary value between 0 (worse) and 10 (best))
1 year
Psychological outcome measure
the EuroQol-5D
1 year
Psychological outcome measure
the mini-mental state examination (arbitrary value beween 0 and 30)
1 year
Psychological outcome measure
the prosthetic evaluation questionnaire
1 year
Psychological outcome measure
the system usability scale
1 year
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 28, 2020
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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