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OpenTrials
Completed

NCT Number: NCT05407545

Evaluation of a Motorised Prosthetic Knee

The study will investigate the effect over time of the Power Knee (Össur) on performance during daily activities in people with a unilateral transfemoral amputation, will determine subjective feelings and gait kinematics over time during daily activities and will investigate the association between subjective feelings and objective outcomes of performing daily activities.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vrije Universiteit Brussel

Brussels, 1050, Belgium

About this study

Participants will visit the lab 6 times over a period of 5 weeks. The study includes a familiarisation phase (3 measuring moments) followed by the experimental phase (3 measuring moments). During the measuring sessions, participants will perform four tasks with their current prosthesis and with the Power Knee (Össur). The order in which the devices will be tested, will be reversed on each measuring moment to control for possible order effects and fatigue.

The experimental protocol will entail an L-test and slope walking test that will each be performed 3 times, followed by a 6 minutes of hallway walking (6MWT), 10 min rest and a dual-task 6MWT.

The slope walking test assesses the participants' ability to ascend and descend a 6 m long ramp of 10% inclination as fast as possible. For safety reasons bilateral handrails are warranted. Participants start the test in an upright position in front of the ramp and are asked to ascend the ramp, turn around on the platform, descend the ramp and return to the starting position.

The L-test, requires higher physical activity of the user. During the L-test, participants are asked to rise from a chair, walk 7 meters, turn 90 degrees, walk 3 meters, turn 180 degrees and then return in the same way to the seated position. A total distance of 20 meter is covered.

The 6MWT will be performed on a hallway at a self-selected walking speed, which closely relates to the most efficient walking speed.

The dual-task 6MWT will be compiled out of conducting a 6MWT while performing a cognitive task, i.e. serial subtractions. Serial subtraction is mental arithmetic task that tests attention and working memory. Participants will be asked to continually subtract sevens from a random selected 3-digit number as long as the duration of the test.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral transfemoral (above knee) amputation
  • Healthy subject
  • Medicare Functional Classification Level: K3-4

Exclusion criteria

  • Any neurological disease
  • Upper limb or bilateral amputation
  • Stump pain or bad fit of the socket

Treatment and study plan

Current prosthesis

Device

A unilateral transfemoral amputee will conduct experiments with the current prosthesis

Active Prosthesis (PowerKnee)

Device

A unilateral transfemoral amputee will conduct experiments with the Power Knee. The PowerKnee is an active prosthesis developed by Össur.

Primary outcomes

  1. Performance

    Time frame: 70 minutes

    Time needed to perform the L-test and slope walking test

  2. Performance

    Time frame: 72 minutes

    Accuracy of the serial subtractions during the dual-6MWT in %

  3. Performance

    Time frame: 144 minutes

    Distance covered during the 6MWT and dual-6MWT

Secondary outcomes

  1. Physiological

    Time frame: 286 minutes

    Heart rate during all tasks in beats per minute

  2. Psychological

    Time frame: 100 minutes

    Visual analogue scale for comfort (score: 0= not comfortable, 100 = comfortable) and fatigue (score: 0= not fatiguing, 100 = fatiguing) during all tasks

  3. Psychological

    Time frame: 96 minutes

    Borg rating of perceived exertion (score: 6 = No exertion at all , 20 = Maximal exertion)

  4. Psychological

    Time frame: 200 minutes

    Perceived workload: Nasa-Task Load Index (score: 0 = minimal workload, 100 = Maximal perceived workload )

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Collaborators

  • Össur Iceland ehf

Registry information

Acronym: MOKI-B

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2022
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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