AzTrials
AzTrials

Lower Limb Amputation Above Knee (Injury)MOKI-BNCT05407545

Evaluation of a Motorised Prosthetic Knee

A study testing Current prosthesis and Active Prosthesis (PowerKnee) in people with Lower Limb Amputation Above Knee (Injury), run by Vrije Universiteit Brussel at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
Current prosthesis and Active Prosthesis (PowerKnee)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteBelgium
Study dates
2 Jun 2023to 22 Mar 2024
Phase
Interventional
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 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Vrije Universiteit Brussel

    Brussels, 1050

Other trials in Belgium

About this study

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.

Read the 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.

Being tested
Current prosthesis, Active Prosthesis (PowerKnee)
Medical subject headings
Wounds and Injuries

What participants receive

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

  • Current prosthesisDevice

    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.

Study groups in NCT05407545
Study groupRoleWhat they receive
ProsthesisExperimentalA unilateral transfemoral amputee will conduct experiments with the active prosthesis and with the current prosthesis.
Receives: Device: Current prosthesis; Device: Active Prosthesis (PowerKnee)

What is being measured

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

  1. Performance

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

    Measured: 70 minutes

  2. Performance

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

    Measured: 72 minutes

  3. Performance

    Distance covered during the 6MWT and dual-6MWT

    Measured: 144 minutes

Secondary outcomes (4)

  1. Physiological

    Heart rate during all tasks in beats per minute

    Measured: 286 minutes

  2. Psychological

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

    Measured: 100 minutes

  3. Psychological

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

    Measured: 96 minutes

  4. Psychological

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

    Measured: 200 minutes

Timeline

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

  1. First posted7 Jun 2022
  2. Study start2 Jun 2023
  3. Primary completion22 Mar 2024
  4. Study completion22 Mar 2024

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05407545
Sponsor's protocol ID
EC-2022-184
Acronym
MOKI-B
Status last verified
Feb 2025
First submitted
1 Jun 2022
Last updated
24 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cox PD, Frengopoulos CA, Hunter SW, Sealy CM, Deathe AB, Payne MWC. Impact of Course Configuration on 6-Minute Walk Test Performance of People with Lower Extremity Amputations. Physiother Can. 2017;69(3):197-203. doi: 10.3138/ptc.2016-24.

    PubMed 30275635

  • Howard CL, Wallace C, Perry B, Stokic DS. Comparison of mobility and user satisfaction between a microprocessor knee and a standard prosthetic knee: a summary of seven single-subject trials. Int J Rehabil Res. 2018 Mar;41(1):63-73. doi: 10.1097/MRR.0000000000000267.

    PubMed 29293160

  • General Assembly of the World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent. 2014 Summer;81(3):14-8.

    PubMed 25951678

  • Gailey RS, Gaunaurd I, Agrawal V, Finnieston A, O'Toole C, Tolchin R. Application of self-report and performance-based outcome measures to determine functional differences between four categories of prosthetic feet. J Rehabil Res Dev. 2012;49(4):597-612. doi: 10.1682/jrrd.2011.04.0077.

    PubMed 22773262

  • Ghillebert J, Bock SD, Flynn L, Geeroms J, Tassignon B, Roelands B, et al. Guidelines and Recommendations to Investigate the Efficacy of a Lower-Limb Prosthetic Device: A Systematic Review. IEEE Transactions on Medical Robotics and Bionics. 2019;1(4):279-96.

  • Williams RM, Turner AP, Orendurff M, Segal AD, Klute GK, Pecoraro J, Czerniecki J. Does having a computerized prosthetic knee influence cognitive performance during amputee walking? Arch Phys Med Rehabil. 2006 Jul;87(7):989-94. doi: 10.1016/j.apmr.2006.03.006.

    PubMed 16813788

  • Omana H, Madou E, Montero-Odasso M, Payne MW, Viana R, Hunter SW. The effect of dual-task testing on the balance and gait of people with lower limb amputations: A systematic review. PM R. 2023 Jan;15(1):94-128. doi: 10.1002/pmrj.12702. Epub 2021 Nov 13.

    PubMed 34464018

  • Morgan SJ, Hafner BJ, Kelly VE. Dual-task walking over a compliant foam surface: A comparison of people with transfemoral amputation and controls. Gait Posture. 2017 Oct;58:41-45. doi: 10.1016/j.gaitpost.2017.07.033. Epub 2017 Jul 10.

    PubMed 28711652

  • Lee KA, Hicks G, Nino-Murcia G. Validity and reliability of a scale to assess fatigue. Psychiatry Res. 1991 Mar;36(3):291-8. doi: 10.1016/0165-1781(91)90027-m.

    PubMed 2062970

  • Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

    PubMed 7154893

  • Hart SG, Staveland LE. Development of NASA-TLX (Task Load Index): Results of Empirical and Theoretical Research. In: Hancock PA, Meshkati N, editors. Advances in Psychology. 52: North-Holland; 1988. p. 139-83.

  • De Pauw K, Cherelle P, Tassignon B, Van Cutsem J, Roelands B, Marulanda FG, Lefeber D, Vanderborght B, Meeusen R. Cognitive performance and brain dynamics during walking with a novel bionic foot: A pilot study. PLoS One. 2019 Apr 3;14(4):e0214711. doi: 10.1371/journal.pone.0214711. eCollection 2019.

    PubMed 30943265

  • Lathouwers E, Maricot A, Tassignon B, Geers S, Flynn L, Verstraten T, De Pauw K. User accommodation to an active microprocessor-controlled knee in individuals with unilateral transfemoral amputation: a 5-week non-randomized trial. J Neuroeng Rehabil. 2025 May 6;22(1):105. doi: 10.1186/s12984-025-01637-5.

    PubMed 40329316

Questions about this trial

What is this clinical trial studying?

A study testing Current prosthesis and Active Prosthesis (PowerKnee) in people with Lower Limb Amputation Above Knee (Injury), run by Vrije Universiteit Brussel at 1 site in Belgium.

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 3 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: finished, as of the sponsor's last update on 24 Feb 2025. 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 Belgium. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance (time frame: 70 minutes). 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 NCT05407545, which also lists 13 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 24 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in