The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses. The main questions are:
* Do individuals with MPKs have fewer fall-related health issues compared to those with non-microprocessor-controlled prosthetic knees (nMPKs)? * Do individuals with MPKs have increased mobility, faster walking speed, and improved quality of life compared to those with nMPKs?
Participants who have recently received an nMPK as part of their regular care can join the study. Those randomized to the control group will keep using their nMPK, while those randomized to the intervention group will receive a stance-and-swing MPK or a stance-only MPK.
Unilateral transfemoral or knee disarticulation limb loss.
6 months or longer since time of limb loss.
Current user of a prosthesis with a non-microprocessor-controlled prosthetic knee.
Received a replacement prosthesis with a non-microprocessor knee in the past 4-24 months.
Any health condition that would prevent safely completing trial activities.
Any individuals that weigh 275 lbs or more.
Any individuals who wear their prosthesis less than 3 days a week or less than a total of 24 hours a week
Individuals with a history of acute or chronic residual limb breakdown
Parallel
Ottobock C-Leg 4 Microprocessor Knee
DeviceSubjects in the intervention group who can walk more than 0.83m/s in the 2-minute walk test (2MWT) will receive the Ottobock C-Leg 4, a stance-and-swing microprocessor knee.
Ottobock Kenevo
DeviceSubjects in the intervention group who can walk up to 0.83m/s (3km/hr) in the 2-minute walk test (2MWT) will receive the Kenevo, a stance-only microprocessor knee.
Prosthetic Limb Users Survey of Fall-Related Self-Efficacy (PLUS-F-SEF)
The PLUS-F-SEF is a 15-item self-report instrument we developed in the present study to measure perceived ability to avoid a loss of balance while performing an activity. Respondents rate their degree of confidence on a 5-point scale from "not at all confident" (1) to "very much confident" (5). A standardized T-score is generated for the PLUS-F-SEF using a lookup table that converts the raw score to a T-score.
Prosthetic Limb Users Survey of Fall-Related Anxiety (PLUS-F-ANX)
The PLUS-F-ANX is a 15-item self-report instrument we developed in the present study to measure perceived apprehensions or concerns about losing one's balance or falling. Respondents rate the frequency with which they experience various emotional responses on a 5-point scale from "never" (1) to "always" (5). A standardized T-score is generated for the PLUS-F-ANX using a lookup table that converts the raw score to a T-score.
Prosthetic Limb Users Survey of Fall-Related Avoidance Behaviors (PLUS-F-AVB)
The PLUS-F-AVB is a 15-item self-report instrument we developed in the present study to measure perceived changes in the manner or frequency with which activities are performed to avoid losing one's balance or falling. Respondents rate the frequency with which they make changes on a 5-point scale from "never" (1) to "always" (5). A standardized T-score is generated for the PLUS-F-AVB using a lookup table that converts the raw score to a T-score.
Prosthetic Limb Users Survey of Fall-Related Interference (PLUS-F-INT)
The PLUS-F-INT is a 15-item self-report instrument we developed in the present study to measure perceived restrictions in social, cognitive, emotional, and/or physical life situations due to risk of falls. Respondents rate the amount of interference on a 5-point scale from "not at all" (1) to "very much" (5). A standardized T-score is generated for the PLUS-F-INT using a lookup table that converts the raw score to a T-score.
EuroQol 5 Dimensions (EQ-5D)
The EQ-5D is a self-report measure of health-related quality of life (HRQL). The EQ-5D includes a descriptive component and a visual analog scale (VAS). The descriptive component evaluates respondents' HRQL in five areas (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) using a five- or three-level response option. We will use the five-level response option (EQ-5D-5L) for this study, where level 1 indicates "no problem" and level 5 indicates "unable to/extreme problems." The VAS component measures the respondent's HRQL on a 0 (the worst imaginable health) to 100 (the best imaginable health) VAS scale.
Balance Recovery Scale (BRC)
The BRC is a 19-item self-report questionnaire designed to measure balance recovery self-efficacy (i.e., perceived reactive balance recovery). Respondents rate the degree of confidence with which they can recover from different losses of balance on a 10-point scale, from "cannot do at all" (0) to "highly certain can do" (10). A summary score is generated from the responses to questions in the BRC.
Fear of Falling Avoidance Behaviors Questionnaire (FFABQ)
The FFABQ is a 14-item self-report instrument that measures the degree to which respondents avoid activities due to their fear of falling. Respondents rate the amount of times they avoid select activities due to their fear of falling on a 5-point scale from "always (100% of the time)" to "never (0% of the time)." A summary score is generated from the responses to questions in the FFABQ.
Prosthetic Limb Users Survey of Mobility (PLUS-M)
The PLUS-M is a 12-item self-report instrument we developed in a prior study to measure mobility with an LLP. Respondents rate their perceived difficulty with performing various household and community activities on a 5-point scale, ranging from "without any difficulty" (5) to "unable to do" (1). A standardized T-score is generated for the PLUS-M using a lookup table that converts the raw score to a T-score.
Click on the lead sponsor to view all of their trials.
Hanger Institute for Clinical Research and Education, LLC
Lead sponsor
University of Washington
Collaborator
U.S. Army Medical Research Acquisition Activity
Collaborator
