Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2023-06-02
2024-03-22
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Prosthesis
A unilateral transfemoral amputee will conduct experiments with the active prosthesis and with the current prosthesis.
Current prosthesis
A unilateral transfemoral amputee will conduct experiments with the current prosthesis
Active Prosthesis (PowerKnee)
A unilateral transfemoral amputee will conduct experiments with the Power Knee. The PowerKnee is an active prosthesis developed by Össur.
Interventions
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Current prosthesis
A unilateral transfemoral amputee will conduct experiments with the current prosthesis
Active Prosthesis (PowerKnee)
A unilateral transfemoral amputee will conduct experiments with the Power Knee. The PowerKnee is an active prosthesis developed by Össur.
Eligibility Criteria
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Inclusion Criteria
* Healthy subject
* Medicare Functional Classification Level: K3-4
Exclusion Criteria
* Upper limb or bilateral amputation
* Stump pain or bad fit of the socket
18 Years
75 Years
ALL
Yes
Sponsors
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Össur Iceland ehf
INDUSTRY
Vrije Universiteit Brussel
OTHER
Responsible Party
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Kevin De Pauw
Prof. Dr.
Principal Investigators
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Kevin De Pauw
Role: PRINCIPAL_INVESTIGATOR
Vrije Universiteit Brussel
Locations
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Vrije Universiteit Brussel
Brussels, , Belgium
Countries
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References
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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.
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.
Other Identifiers
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EC-2022-184
Identifier Type: -
Identifier Source: org_study_id
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