The Effect of Different Microprocessor Knee Prostheses on Mobility and Gait Parameters in Transfemoral Amputees

NCT04966936 | Unknown

• 1 other identifier: 17
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Keywords

Transfemoral Amputee; microprocessor knee prostheses

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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)

  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).

  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)

  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

  Through study completion, an average of 1 month

Study Arms (3)

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.

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.

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.

Other: questionnaires for clinical assessments; Other: 2 minute walking test; Other: The gait analysis at the motion analysis laboratory.

Interventions

questionnaires for clinical assessments OTHER

Amputee Mobility Predictor, Locomotor Capacity Index, visual analog scale (VAS)

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 test OTHER

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).

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. 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

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

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Fatma Özcan, MD

  Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Özcan, MD

CONTACT

+903122912412; fatma_yumus@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Specialist

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 19, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 19, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)