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

May 17, 2024 updated by: Johannes Schroeter, Median

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects
Baseline measurements for all subjects is carried out with their own passive microprocessor-controlled knee prosthesis. After 4 weeks of use of active microprocessor-controlled knee, second measurement is carried out. All subjects follow the same study path.
Device: active microprocessor-controlled knee
Active microprocessor-controlled knees are motorized prosthesis, actively supporting the users while walking, getting up, and climbing stairs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 minute walk test
Time Frame: baseline (t1), after 4 weeks (t2)
Subject walks for 6 minutes a defined track and covered track is reported as meters
baseline (t1), after 4 weeks (t2)
Stair Assessment Index (SAI)
Time Frame: baseline (t1), after 4 weeks (t2)
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)
Hill Assessment Index (SAI)
Time Frame: baseline (t1), after 4 weeks (t2)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go Test (TUG)
Time Frame: baseline (t1), after 4 weeks (t2)
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)
Amputee Mobility Predictor with Prosthesis (AMP-PRO)
Time Frame: baseline (t1), after 4 weeks (t2)
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)
Locomotor Capability Index 5 (LCI 5)
Time Frame: baseline (t1), after 4 weeks (t2)
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)
Fear of falling
Time Frame: baseline (t1), after 4 weeks (t2)
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)
Prosthetic Limb User´s Survey of Mobility (PLUS-M)
Time Frame: baseline (t1), after 4 weeks (t2)
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)
EuroQol (EQ5D-5L) questionnaire
Time Frame: baseline (t1), after 4 weeks (t2)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Median

Collaborators

Johannes Gutenberg University Mainz

Investigators

  • Principal Investigator: Johannes Schröter, Dr. med., MEDIAN Reha-Center Wiesbaden Sonnenberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2024

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Intuy2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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