Clinical trial NCT04966936: The Effect of Different Microprocessor Knee Prostheses on Mobility and Gait Parameters in Transfemoral Amputees
Official title: The Effect of Different Microprocessor Knee Prostheses on Mobility and Gait Parameters in Unilateral Traumatic Transfemoral Amputees
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amputation
Keywords: Transfemoral Amputee
microprocessor knee prostheses
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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)

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. be over 18 age
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:

1. Under the age of 18
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

Primary outcomes:
measure: Amputee Mobility Predictor
timeFrame: Through study completion, an average of 1 month
measure: Locomotor Capacity Index
timeFrame: Through study completion, an average of 1 month
measure: visual analog scale
timeFrame: Through study completion, an average of 1 month
measure: The 2-minute walk test
timeFrame: Through study completion, an average of 1 month
measure: Temporo-spatial parameters of the patients in the motion analysis laboratory
timeFrame: Through study completion, an average of 1 month
measure: kinematic parameters of the patients in the motion analysis laboratory
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study officials:
affiliation: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Fatma Özcan, MD
role: PRINCIPAL_INVESTIGATOR
References: