- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04966936
The Effect of Different Microprocessor Knee Prostheses on Mobility and Gait Parameters in Transfemoral Amputees
The Effect of Different Microprocessor Knee Prostheses on Mobility and Gait Parameters in Unilateral Traumatic Transfemoral Amputees
Microprocessor knee joints are prosthetic knee joints with an integrated processor or a computer that can analyze data. During walking, parameters such as step speed, joint angles, and weight transferred through sensors are analyzed by the computer inside the joint and determines the movement for the safest and most normal walking. They have different features from each other in terms of weight/height, sensor and processor frequency, load carrying capacity, phase control (hydraulic, pneumatic, magnetic), battery properties, water resistance, and special activity mode. C-Leg, Genium, Genium X3, Rheo Knee 3, Rheo Knee XC, Orion etc. prostheses of different companies are used as oscillating and compression phase microprocessor knee prostheses.
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Fatma Özcan, MD
- Phone Number: +903122912412
- Email: fatma_yumus@hotmail.com
Study Locations
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-
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Ankara, Turkey, 06800
- Recruiting
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
-
Contact:
- Fatma Özcan, MD
- Phone Number: +903122912412
- Email: fatma_yumus@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- be over 18 age
- Having a unilateral traumatic transfemoral amputation for at least 3 months
- Using prosthesis for at least 3 months
- Not having cognitive problems
- Using your current prosthesis for at least 4 hours a day
- No concomitant orthopedic problem in the contralateral lower extremity
Exclusion Criteria:
- Under the age of 18
- Presence of neurological, cardiovascular and pulmonary disease that may affect walking performance
- Being inadequate in Turkish communication
- Residual extremity skin loss
- Using a walking aid
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Amputee Mobility Predictor, Locomotor Capacity Index, visual analog scale (VAS)
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).
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.
|
Amputee Mobility Predictor, Locomotor Capacity Index, visual analog scale (VAS)
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).
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.
|
Amputee Mobility Predictor, Locomotor Capacity Index, visual analog scale (VAS)
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).
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amputee Mobility Predictor
Time Frame: Through study completion, an average of 1 month
|
The amputee is evaluated with 21 functions and a score is obtained.
According to this score, the patient's K activity level is determined.
K0: The patient is immobile, does not have the potential and ability to ambulate or transfer with the prosthesis.
K1: The patient can use the prosthesis for ambulation and transfers.
Prostheses provide limited or unlimited in-home ambulation.
K2: The patient provides limited ambulation in the community with the prosthesis.
K3: The patient has the potential to use the prosthesis at variable speeds.
The patient can use the prosthesis not only for ambulation, but also for occupation, therapeutic activities and exercises.
K4: The patient has the potential and ability to use the prosthesis in high-energy activities.
|
Through study completion, an average of 1 month
|
Locomotor Capacity Index
Time Frame: Through study completion, an average of 1 month
|
the patient's ability to perform 14 activities with the prosthesis is evaluated.
The total maximum score is 42, and the higher the total score, the higher the locomotor capacity.
|
Through study completion, an average of 1 month
|
visual analog scale
Time Frame: Through study completion, an average of 1 month
|
The visual analog scale is a 10 cm long line and patients are asked to mark a point on this line that they deem appropriate according to the degree of satisfaction (0: not at all satisfied with the prosthesis, 10: the highest satisfaction with the prosthesis)
|
Through study completion, an average of 1 month
|
The 2-minute walk test
Time Frame: Through study completion, an average of 1 month
|
In this 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 is recorded in meters (m).
|
Through study completion, an average of 1 month
|
Temporo-spatial parameters of the patients in the motion analysis laboratory
Time Frame: Through study completion, an average of 1 month
|
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)
|
Through study completion, an average of 1 month
|
kinematic parameters of the patients in the motion analysis laboratory
Time Frame: Through study completion, an average of 1 month
|
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
|
Through study completion, an average of 1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Fatma Özcan, MD, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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