AmputationNCT04966936
The Effect of Different Microprocessor Knee Prostheses on Mobility and Gait Parameters in Transfemoral Amputees
An observational study of Amputation, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Amputation
- What is being tested?
- questionnaires for clinical assessments, 2 minute walking test and The gait analysis at the motion analysis laboratory.
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 27 unilateral traumatic transfemoral amputee patients (9 patients using C-Leg prostheses, 9 patients using Genium prostheses, 9 patients using Genium-X3 prostheses)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara, 06800
Fatma Özcan, MD, +903122912412, fatma_yumus@hotmail.com
About this study
Official title: 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.
Read the detailed description
The study will be carried out with patients who applied to the outpatient clinic or who received inpatient treatment in the orthopedic rehabilitation (amputee) clinic. The patient's demographic information (age, gender, height, weight, body mass index, education level, occupation, marital status) and clinical characteristics (amputation date, cause of injury, amputation side, etc.) will be recorded with the evaluation to be made to the patient. 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.
- Conditions
- Amputation
- Being tested
- questionnaires for clinical assessments, 2 minute walking test, The gait analysis at the motion analysis laboratory.
- Keywords
- Transfemoral Amputee, microprocessor knee prostheses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires for clinical assessmentsOther
Amputee Mobility Predictor, Locomotor Capacity Index, visual analog scale (VAS)
2 minute walking testOther
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.Other
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: questionnaires for clinical assessments; Other: 2 minute walking test; Other: The gait analysis at the motion analysis laboratory. | |
| 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. Receives: Other: questionnaires for clinical assessments; Other: 2 minute walking test; Other: The gait analysis at the motion analysis laboratory. | |
| 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. Receives: Other: questionnaires for clinical assessments; Other: 2 minute walking test; Other: The gait analysis at the motion analysis laboratory. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputee Mobility Predictor
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.
Measured: Through study completion, an average of 1 month
Locomotor Capacity Index
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.
Measured: Through study completion, an average of 1 month
visual analog scale
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)
Measured: Through study completion, an average of 1 month
The 2-minute walk test
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).
Measured: Through study completion, an average of 1 month
Temporo-spatial parameters of the patients in the motion analysis laboratory
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)
Measured: Through study completion, an average of 1 month
kinematic parameters of the patients in the motion analysis laboratory
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
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Jul 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Fatma Özcan, MD, Principal investigator, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966936
- Sponsor's protocol ID
- 17
- Status last verified
- Jun 2021
- First submitted
- 2 Jul 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Microprocessor Knee Prostheses on Mobility and Gait Parameters in Unilateral Traumatic Transfemoral Amputees
- ClinicalTrials.gov ID
- NCT04966936
- Acronym / sponsor ID
- 17
- Conditions
- Amputation
- Keywords
- Transfemoral Amputee, microprocessor knee prostheses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be carried out with patients who applied to the outpatient clinic or who received inpatient treatment in the orthopedic rehabilitation (amputee) clinic. The patient's demographic information (age, gender, height, weight, body mass index, education level, occupation, marital status) and clinical characteristics (amputation date, cause of injury, amputation side, etc.) will be recorded with the evaluation to be made to the patient. 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unilateral traumatic transfemoral amputee patients using C-Leg prosthesis | – | Other: questionnaires for clinical assessments, Other: 2 minute walking test, Other: The gait analysis at the motion analysis laboratory.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. |
| Unilateral traumatic transfemoral amputee patients using Genium prosthesis | – | Other: questionnaires for clinical assessments, Other: 2 minute walking test, Other: The gait analysis at the motion analysis laboratory.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. |
| Unilateral traumatic transfemoral amputee patients using Genium-X3 prosthesis | – | Other: questionnaires for clinical assessments, Other: 2 minute walking test, Other: The gait analysis at the motion analysis laboratory.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 27 unilateral traumatic transfemoral amputee patients (9 patients using C-Leg prostheses, 9 patients using Genium prostheses, 9 patients using Genium-X3 prostheses)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaires for clinical assessmentsAmputee Mobility Predictor, Locomotor Capacity Index, visual analog scale (VAS) | Other | Unilateral traumatic transfemoral amputee patients using C-Leg prosthesis, Unilateral traumatic transfemoral amputee patients using Genium prosthesis, Unilateral traumatic transfemoral amputee patients using Genium-X3 prosthesis |
| 2 minute walking testthe 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). | Other | Unilateral traumatic transfemoral amputee patients using C-Leg prosthesis, Unilateral traumatic transfemoral amputee patients using Genium prosthesis, Unilateral traumatic transfemoral amputee patients using Genium-X3 prosthesis |
| 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 | Other | Unilateral traumatic transfemoral amputee patients using C-Leg prosthesis, Unilateral traumatic transfemoral amputee patients using Genium prosthesis, Unilateral traumatic transfemoral amputee patients using Genium-X3 prosthesis |
Primary outcome
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.
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.
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)
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).
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)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Özcan, MD principal investigator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Özcan, MD (+903122912412, fatma_yumus@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputee Mobility Predictor (time frame: Through study completion, an average of 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.