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Evaluation of a Motorised Prosthetic Knee

Evaluation of a Motorised Prosthetic Knee

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05407545
Acronym
MOKI-B
Enrollment
7
Registered
2022-06-07
Start date
2023-06-02
Completion date
2024-03-22
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Limb Amputation Above Knee (Injury)

Brief summary

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.

Detailed description

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.

Interventions

DEVICECurrent prosthesis

A unilateral transfemoral amputee will conduct experiments with the current prosthesis

DEVICEActive Prosthesis (PowerKnee)

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

Sponsors

Össur Iceland ehf
CollaboratorINDUSTRY
Vrije Universiteit Brussel
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Performance70 minutesTime needed to perform the L-test and slope walking test

Secondary

MeasureTime frameDescription
Physiological286 minutesHeart rate during all tasks in beats per minute
Psychological100 minutesVisual analogue scale for comfort (score: 0= not comfortable, 100 = comfortable) and fatigue (score: 0= not fatiguing, 100 = fatiguing) during all tasks

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026