NCT05407545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

June 2, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2024

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

June 1, 2022

Last Update Submit

February 20, 2025

Conditions

Lower Limb Amputation Above Knee (Injury)

Outcome Measures

Primary Outcomes (3)

  • Performance

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

    70 minutes

  • Performance

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

    72 minutes

  • Performance

    Distance covered during the 6MWT and dual-6MWT

    144 minutes

Secondary Outcomes (4)

  • Physiological

    286 minutes

  • Psychological

    100 minutes

  • Psychological

    96 minutes

  • Psychological

    200 minutes

Study Arms (1)

Prosthesis

EXPERIMENTAL

A unilateral transfemoral amputee will conduct experiments with the active prosthesis and with the current prosthesis.

Device: Current prosthesisDevice: Active Prosthesis (PowerKnee)

Interventions

Current prosthesisDEVICE

A unilateral transfemoral amputee will conduct experiments with the current prosthesis

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.

Prosthesis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Brussel

Brussels, 1050, Belgium

Location

Related Publications (13)

  • 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.

    PMID: 30275635BACKGROUND

  • 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.

    PMID: 29293160BACKGROUND

  • 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.

    PMID: 25951678BACKGROUND

  • 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.

    PMID: 22773262BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 16813788BACKGROUND

  • 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.

    PMID: 34464018BACKGROUND

  • 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.

    PMID: 28711652BACKGROUND

  • 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.

    PMID: 2062970BACKGROUND

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

    PMID: 7154893BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 30943265BACKGROUND

  • 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.

    PMID: 40329316DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Kevin De Pauw

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 7, 2022

Study Start

June 2, 2023

Primary Completion

March 22, 2024

Study Completion

March 22, 2024

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)