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

NCT06406491 | Recruiting

• 1 other identifier: Intuy2024
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Keywords

transfemoral amputation; prosthetic user; microprocessor-controlled knee; functional outcomes; patient-reported outcomes

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (6)

• Timed Up and Go Test (TUG)

  baseline (t1), after 4 weeks (t2)

• Amputee Mobility Predictor with Prosthesis (AMP-PRO)

  baseline (t1), after 4 weeks (t2)

• Prosthetic Limb User´s Survey of Mobility (PLUS-M)

  baseline (t1), after 4 weeks (t2)

• EuroQol (EQ5D-5L) questionnaire

  baseline (t1), after 4 weeks (t2)

• Locomotor Capability Index 5 (LCI 5)

  baseline (t1), after 4 weeks (t2)

Study Arms (1)

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

Interventions

active microprocessor-controlled knee DEVICE

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

Subjects

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Median: lead
• Johannes Gutenberg University Mainz: collaborator

Study Sites (1)

MEDIAN Clinics

Wiesbaden, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 27632668 BACKGROUND

• 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.

  PMID: 37131231 BACKGROUND

• 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.

  PMID: 36240032 BACKGROUND

• 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.

  PMID: 28113346 BACKGROUND

Study Officials

• Johannes Schröter, Dr. med.

  MEDIAN Reha-Center Wiesbaden Sonnenberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Schröter, Dr. med.

CONTACT

+49 611571751; johannes.schroeter@median-kliniken.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director and Head of Orthopaedic Department

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: April 23, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)