Passive Microprocessor-controlled Knees vs. Active Microprocessor-controlled Knees After Transfemoral Amputation

Amputation Clinical Trial

Official title:

Application Observation of Passive Microprocessor-controlled Knees vs. Active Microprocessor-controlled Knees After Transfemoral Amputation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06406491
• Other study ID #: Intuy2024
• Status: Recruiting
• Start date: April 23, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: May 2024
• Source: Median
• Contact: Johannes Schröter, Dr. med.
• Phone: +49 611571751
• Email: johannes.schroeter[@]median-kliniken.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation

Intervention

Device:
• active microprocessor-controlled knee
Active microprocessor-controlled knees are motorized prosthesis, actively supporting the users while walking, getting up, and climbing stairs.

Locations

Country	Name	City	State
Germany	MEDIAN Clinics	Wiesbaden

Sponsors (2)

Lead Sponsor	Collaborator
Median	Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walk test	Subject walks for 6 minutes a defined track and covered track is reported as meters	baseline (t1), after 4 weeks (t2)
Primary	Stair Assessment Index (SAI)	Subjects walks up and down a stair 3 times, the investigator rates the performance on a scale from 0 (cannot to/refused to do) - 13 (without rail or assisstive device, step-over-step pattern) points	baseline (t1), after 4 weeks (t2)
Primary	Hill Assessment Index (SAI)	Subjects walks up and down a hill 3 times, the investigator rates the performance on a scale from 0 (cannot to/refused to do) - 11 (even step without assisstive device) points	baseline (t1), after 4 weeks (t2)
Secondary	Timed Up and Go Test (TUG)	Subjects gets up from a chair, walks 3 metres, turns, walks back to the chair, and sits down. The investigator records the time (seconds).	baseline (t1), after 4 weeks (t2)
Secondary	Amputee Mobility Predictor with Prosthesis (AMP-PRO)	Functional Assessment of 21 different tasks and evaluations. The investigator rates each tasks and sums up the score (min. 0; max. 47 points)	baseline (t1), after 4 weeks (t2)
Secondary	Prosthetic Limb User´s Survey of Mobility (PLUS-M)	Questionnaire assessing users´mobility with 12 questions. Users rate their answers from 0 ("not able to") to 5 (without any difficulties") points. Results are presented as t-scores from 23.1 - 65.7	baseline (t1), after 4 weeks (t2)
Secondary	EuroQol (EQ5D-5L) questionnaire	Questionnaire assessing users´ quality of life. Users rate 5 statements with 1 ("no agreement") to 5 ("complete agreement") points. In addition, the users rate their perceived health on a scale from 0% - 100%. Results are presented as health utility scores. Minimum score is -0.661, maximum score is 1.	baseline (t1), after 4 weeks (t2)
Secondary	Locomotor Capability Index 5 (LCI 5)	Questionnaire assessing users´ locomotor abilities. Users rate statements with 0 ("no") to 4 ("yes, without any further assistance) points. Results are presented as "basic activities" (7questions) and "advanced activities" (7 questions). Minimum score is 0 points, maximum score is 28 points for each of the two categories.	baseline (t1), after 4 weeks (t2)
Secondary	Fear of falling	Subjects rate their fear of falling indoors and outdoors on a visual analogue scale. Minimum score is 0 (no fear) and maximum score is 10 (maximum fear).	baseline (t1), after 4 weeks (t2)