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AmputationNCT06406491

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

An observational study of Amputation, run by Median at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Amputation
Type of treatment
Medical device
How many people
10 participants
Where
1 siteGermany
Study dates
23 Apr 2024to 31 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Johannes Schröter, Dr. med. contact

+49 611571751

johannes.schroeter@median-kliniken.de

Germany1 site, 1 recruiting

  • MEDIAN Clinics

    Wiesbaden

    Johannes Schroeter, Dr. med., 0049 611 575811, johannes.schroeter@median-kliniken.de

    Recruiting

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Conditions
Amputation
Being tested
active microprocessor-controlled knee
Keywords
transfemoral amputation, prosthetic user, microprocessor-controlled knee, functional outcomes, patient-reported outcomes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • active microprocessor-controlled kneeDevice

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

Study groups in NCT06406491
Study groupRoleWhat they receive
SubjectsBaseline 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.
Receives: Device: active microprocessor-controlled knee

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 minute walk test

    Subject walks for 6 minutes a defined track and covered track is reported as meters

    Measured: baseline (t1), after 4 weeks (t2)

  2. 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

    Measured: baseline (t1), after 4 weeks (t2)

  3. 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

    Measured: baseline (t1), after 4 weeks (t2)

Secondary outcomes (6)

  1. 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).

    Measured: baseline (t1), after 4 weeks (t2)

  2. 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)

    Measured: baseline (t1), after 4 weeks (t2)

  3. 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

    Measured: baseline (t1), after 4 weeks (t2)

  4. 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.

    Measured: baseline (t1), after 4 weeks (t2)

  5. 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.

    Measured: baseline (t1), after 4 weeks (t2)

  6. 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).

    Measured: baseline (t1), after 4 weeks (t2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2024
  2. Study start23 Apr 2024
  3. Primary completion31 Oct 2024 (estimated)
  4. Study completion31 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06406491
Sponsor's protocol ID
Intuy2024
Status last verified
May 2024
First submitted
6 May 2024
Last updated
20 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27632668

  • 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.

    PubMed 37131231

  • 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.

    PubMed 36240032

  • 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.

    PubMed 28113346

Questions about this trial

What is this clinical trial studying?

An observational study of Amputation, run by Median at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Johannes Schröter, Dr. med. (+49 611571751, johannes.schroeter@median-kliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 minute walk test (time frame: baseline (t1), after 4 weeks (t2)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06406491, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.

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