Clinical trial NCT06406491: Passive Microprocessor-controlled Knees vs. Active Microprocessor-controlled Knees After Transfemoral Amputation
Official title: Application Observation of Passive Microprocessor-controlled Knees vs. Active Microprocessor-controlled Knees After Transfemoral Amputation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amputation
Keywords: transfemoral amputation
prosthetic user
microprocessor-controlled knee
functional outcomes
patient-reported outcomes
Lead sponsor: Median
Sponsor class: OTHER
Collaborators: name: Johannes Gutenberg University Mainz
First posted: 2024-05-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of patients with transfemoral amputation or knee-disarticulation. The subjects are already provided with a passive microprocessor-controlled knee, but are about to receive their final prosthesis (6 months past interim prosthesis) or they are entitled for a new prosthesis (usually after 5 years with the same prosthesis). Subjects have a moderate (K2-K3) mobility grade.

Brief summary: This study investigates prosthetic users´ report of passive microprocessor-controlled knees (pMPK) vs. active microprocessor-controlled knees (aMPK). Outcome measurements are assessed at baseline with the pMPK and after 4 weeks of continuous use of aMPK. Measurements consists of functional outcomes, as well as patient-reported outcomes.

Detailed description: The Intuy Knee, an active electronic microprocessor-controlled prosthesis, aims to improve symmetry in joints, torque, and muscle activation compared to passive prostheses. Furthermore, it provides benefits of active prostheses in terms of weight distribution, stair climbing ease, and reduced oxygen consumption. However, there's a lack of research on subjective evaluation by participants. Thus, the study aims to compare the Intuy Knee with passive prostheses regarding functional outcomes and patient-reported outcomes (PROMs).

The target group includes individuals with transfemoral amputation or knee disarticulation, aged 18 and above, with anticipated moderate to high mobility levels, and currently using an electronic prosthetic knee. The study plans to enroll participants nearing the end of their prosthetic cycle, allowing for comparison between different prosthetic options.

Key objectives include comparing walking distance, stair climbing, and hill ascent between passive and active prostheses, as well as evaluating mobility, daily functionality, quality of life, and fear of falling.

The study design is prospective with a pre-post design, aiming for an intra-individual comparison between active and passive prostheses. It outlines inclusion and exclusion criteria, study procedures, and discontinuation criteria for both individual and overall study termination.

Eligibility criteria: Inclusion Criteria:

* transfemoral amputation or knee-disarticulation
* passive microprocessor-controlled knee
* resupply with new prosthesis within the next few months
* K-Level 2 or 3
* body weight no more than 125 kg
* German speakers

Exclusion Criteria:

* age less than 18 years
* unable to give informed consent
* body weight more than 125 kg

Primary outcomes:
measure: 6 minute walk test
timeFrame: baseline (t1), after 4 weeks (t2)
measure: Stair Assessment Index (SAI)
timeFrame: baseline (t1), after 4 weeks (t2)
measure: Hill Assessment Index (SAI)
timeFrame: baseline (t1), after 4 weeks (t2)
Secondary outcomes:
measure: Timed Up and Go Test (TUG)
timeFrame: baseline (t1), after 4 weeks (t2)
measure: Amputee Mobility Predictor with Prosthesis (AMP-PRO)
timeFrame: baseline (t1), after 4 weeks (t2)
measure: Prosthetic Limb User´s Survey of Mobility (PLUS-M)
timeFrame: baseline (t1), after 4 weeks (t2)
measure: EuroQol (EQ5D-5L) questionnaire
timeFrame: baseline (t1), after 4 weeks (t2)
measure: Locomotor Capability Index 5 (LCI 5)
timeFrame: baseline (t1), after 4 weeks (t2)
measure: Fear of falling
timeFrame: baseline (t1), after 4 weeks (t2)
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: MEDIAN Clinics
Study officials:
affiliation: MEDIAN Reha-Center Wiesbaden Sonnenberg
name: Johannes Schröter, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Probsting E, Blumentritt S, Kannenberg A. [Changes in the Locomotor System as a Consequence of Amputation of a Lower Limb]. Z Orthop Unfall. 2017 Feb;155(1):77-91. doi: 10.1055/s-0042-112821. Epub 2016 Sep 15. German.
citation: Hunt GR, Hood S, Gabert L, Lenzi T. Can a powered knee-ankle prosthesis improve weight-bearing symmetry during stand-to-sit transitions in individuals with above-knee amputations? J Neuroeng Rehabil. 2023 May 2;20(1):58. doi: 10.1186/s12984-023-01177-w.
citation: Hunt GR, Hood S, Gabert L, Lenzi T. Effect of Increasing Assistance From a Powered Prosthesis on Weight-Bearing Symmetry, Effort, and Speed During Stand-Up in Individuals With Above-Knee Amputation. IEEE Trans Neural Syst Rehabil Eng. 2023;31:11-21. doi: 10.1109/TNSRE.2022.3214806. Epub 2023 Jan 30.
citation: Ledoux ED, Goldfarb M. Control and Evaluation of a Powered Transfemoral Prosthesis for Stair Ascent. IEEE Trans Neural Syst Rehabil Eng. 2017 Jul;25(7):917-924. doi: 10.1109/TNSRE.2017.2656467. Epub 2017 Jan 20.