The Effect of Different Microprocessor Knee Prostheses on Mobility and Gait Parameters in Transfemoral Amputees
NCT ID: NCT04966936
Last Updated: 2021-07-19
Study Results
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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UNKNOWN
27 participants
OBSERVATIONAL
2021-07-01
2022-08-01
Brief Summary
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Publications on C-leg, Genium and Genium X3 prostheses are limited in international literature. Although there are existing studies comparing C-leg and Genium, there is no study comparing these three prostheses. The investigators think that our study is important because it is the first study in the literature to compare these three prostheses. In this study, the investigators aimed to examine the effects of different microprocessor knee prostheses on mobility and gait parameters in unilateral traumatic transfemoral amputees.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Unilateral traumatic transfemoral amputee patients using C-Leg prosthesis
The activity levels of the patients will be evaluated by the Amputee Mobility Predictor, the mobility of the patients by the Locomotor Capacity Index, the prosthesis satisfaction in general with the visual analog scale (VAS), the walking ability and capacity with the prosthesis will be evaluated by the 2 min walking test, and the gait analysis will be evaluated in the motion analysis laboratory.
questionnaires for clinical assessments
Amputee Mobility Predictor, Locomotor Capacity Index, visual analog scale (VAS)
2 minute walking test
the individual is asked to walk in his natural course within 2 minutes on a track whose distance is measured beforehand, and at the end of two minutes, the distance he walks will be recorded in meters (m).
The gait analysis at the motion analysis laboratory.
Temporo-spatial parameters (gait speed (m/s), cadence (step/s), other foot contact (%), double support time (second), single support time (second), stance phase time (sec), swing phase time (sec), stride length (meters)) and kinematic parameters (hip, knee, ankle joint angles (frontal, sagittal, transverse plane), maximum knee flexion angles in the stance and swing phase, velocity-dependent maximum knee flexion angles in the swing phase, knee flexion moments will be compared
Unilateral traumatic transfemoral amputee patients using Genium prosthesis
The activity levels of the patients will be evaluated by the Amputee Mobility Predictor, the mobility of the patients by the Locomotor Capacity Index, the prosthesis satisfaction in general with the visual analog scale (VAS), the walking ability and capacity with the prosthesis will be evaluated by the 2 min walking test, and the gait analysis will be evaluated in the motion analysis laboratory.
questionnaires for clinical assessments
Amputee Mobility Predictor, Locomotor Capacity Index, visual analog scale (VAS)
2 minute walking test
the individual is asked to walk in his natural course within 2 minutes on a track whose distance is measured beforehand, and at the end of two minutes, the distance he walks will be recorded in meters (m).
The gait analysis at the motion analysis laboratory.
Temporo-spatial parameters (gait speed (m/s), cadence (step/s), other foot contact (%), double support time (second), single support time (second), stance phase time (sec), swing phase time (sec), stride length (meters)) and kinematic parameters (hip, knee, ankle joint angles (frontal, sagittal, transverse plane), maximum knee flexion angles in the stance and swing phase, velocity-dependent maximum knee flexion angles in the swing phase, knee flexion moments will be compared
Unilateral traumatic transfemoral amputee patients using Genium-X3 prosthesis
The activity levels of the patients will be evaluated by the Amputee Mobility Predictor, the mobility of the patients by the Locomotor Capacity Index, the prosthesis satisfaction in general with the visual analog scale (VAS), the walking ability and capacity with the prosthesis will be evaluated by the 2 min walking test, and the gait analysis will be evaluated in the motion analysis laboratory.
questionnaires for clinical assessments
Amputee Mobility Predictor, Locomotor Capacity Index, visual analog scale (VAS)
2 minute walking test
the individual is asked to walk in his natural course within 2 minutes on a track whose distance is measured beforehand, and at the end of two minutes, the distance he walks will be recorded in meters (m).
The gait analysis at the motion analysis laboratory.
Temporo-spatial parameters (gait speed (m/s), cadence (step/s), other foot contact (%), double support time (second), single support time (second), stance phase time (sec), swing phase time (sec), stride length (meters)) and kinematic parameters (hip, knee, ankle joint angles (frontal, sagittal, transverse plane), maximum knee flexion angles in the stance and swing phase, velocity-dependent maximum knee flexion angles in the swing phase, knee flexion moments will be compared
Interventions
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questionnaires for clinical assessments
Amputee Mobility Predictor, Locomotor Capacity Index, visual analog scale (VAS)
2 minute walking test
the individual is asked to walk in his natural course within 2 minutes on a track whose distance is measured beforehand, and at the end of two minutes, the distance he walks will be recorded in meters (m).
The gait analysis at the motion analysis laboratory.
Temporo-spatial parameters (gait speed (m/s), cadence (step/s), other foot contact (%), double support time (second), single support time (second), stance phase time (sec), swing phase time (sec), stride length (meters)) and kinematic parameters (hip, knee, ankle joint angles (frontal, sagittal, transverse plane), maximum knee flexion angles in the stance and swing phase, velocity-dependent maximum knee flexion angles in the swing phase, knee flexion moments will be compared
Eligibility Criteria
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Inclusion Criteria
2. Having a unilateral traumatic transfemoral amputation for at least 3 months
3. Using prosthesis for at least 3 months
4. Not having cognitive problems
5. Using your current prosthesis for at least 4 hours a day
6. No concomitant orthopedic problem in the contralateral lower extremity
Exclusion Criteria
2. Presence of neurological, cardiovascular and pulmonary disease that may affect walking performance
3. Being inadequate in Turkish communication
4. Residual extremity skin loss
5. Using a walking aid
18 Years
MALE
No
Sponsors
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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
OTHER
Responsible Party
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Yasin Demir
Physical Medicine and Rehabilitation Specialist
Principal Investigators
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Fatma Özcan, MD
Role: PRINCIPAL_INVESTIGATOR
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Locations
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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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17
Identifier Type: -
Identifier Source: org_study_id
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