NCT05407545|Completed
Evaluation of a Motorised Prosthetic Knee
MOKI-B
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MOKI-B
Sponsor study identifier
interventional
7
1 country
1
Study Start
June 2, 2023
Actual (reported)Primary Completion
March 22, 2024
Actual (reported)Study Completion
March 22, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 22, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2022
Actual (reported)June 7, 2022
Actual (reported)June 2, 2023
Actual (reported)March 22, 2024
Actual (reported)March 22, 2024
Actual (reported)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
Physiological
286 minutes
Psychological
100 minutes
Psychological
96 minutes
Psychological
200 minutes
A unilateral transfemoral amputee will conduct experiments with the active prosthesis and with the current prosthesis.
A unilateral transfemoral amputee will conduct experiments with the current prosthesis
A unilateral transfemoral amputee will conduct experiments with the Power Knee. The PowerKnee is an active prosthesis developed by Össur.
Vrije Universiteit Brussel
Brussels, 1050, Belgium
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.
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.
Kevin De Pauw
Vrije Universiteit Brussel
7 participants (actual enrollment reported by the registry).
First Submitted
June 1, 2022
First Posted
June 7, 2022
Study Start
June 2, 2023
Actual (reported)C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
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.
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.
Primary Completion
March 22, 2024
Actual (reported)Study Completion
March 22, 2024
Actual (reported)Last Updated
February 24, 2025
Record last verified: 2025-02
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