Evaluation of a Motorised Prosthetic Knee (MOKI-B)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Limb Amputation Above Knee (Injury)
• Intervention / Treatment: Device: Current prosthesis; Device: Active Prosthesis (PowerKnee)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevin De Pauw; Phone Number: +32 (0)2 629 27 53; Email: Kevin.De.Pauw@vub.be
• Study Contact Backup: Name: Elke Lathouwers; Phone Number: +32 (0)2 629 27 06; Email: Elke.Lathouwers@vub.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prosthesis; A unilateral transfemoral amputee will conduct experiments with the active prosthesis and with the current prosthesis.	Device: Current prosthesis; A unilateral transfemoral amputee will conduct experiments with the current prosthesis; Device: Active Prosthesis (PowerKnee); A unilateral transfemoral amputee will conduct experiments with the Power Knee. The PowerKnee is an active prosthesis developed by Össur.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological	Heart rate during all tasks in beats per minute	286 minutes
Psychological	Visual analogue scale for comfort (score: 0= not comfortable, 100 = comfortable) and fatigue (score: 0= not fatiguing, 100 = fatiguing) during all tasks	100 minutes
Psychological	Borg rating of perceived exertion (score: 6 = No exertion at all , 20 = Maximal exertion)	96 minutes
Psychological	Perceived workload: Nasa-Task Load Index (score: 0 = minimal workload, 100 = Maximal perceived workload )	200 minutes

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel
• Collaborators: Össur Ehf
• Investigators: Principal Investigator: Kevin De Pauw, Vrije Universiteit Brussel

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: EC-2022-184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No