Study of Microprocessor-Controlled Prosthetic Knees for Above-Knee Amputees
This study is looking at whether microprocessor-controlled prosthetic knees (MPKs), which have a built-in computer, can help people with above-knee amputations who use prostheses. Specifically, it wants to see if using an MPK like the Ottobock C-Leg 4 or Ottobock Kenevo can reduce fall-related health problems, improve walking, and increase quality of life compared to standard prosthetic knees. You might be able to join if you are an adult with a single above-knee amputation, have been using a prosthesis for at least six months, and currently use a non-microprocessor knee. The study will measure how you feel about falls, your anxiety about falling, and behaviors you might use to avoid falls over 12 months to see if the MPKs are helpful. The study is currently unclear on its recruitment status and plans to enroll 100 participants.
- Study design
- This is a 12-month randomized controlled trial, meaning participants will be randomly assigned to either receive a microprocessor-controlled knee or continue using their current non-microprocessor knee. The study plans to enroll 100 participants.
- What's involved
- You would participate in assessments at baseline, 1 month, 3 months, 6 months, 9 months, and 12 months. You would either continue using your current non-microprocessor knee or receive an Ottobock C-Leg 4 or Ottobock Kenevo prosthetic knee.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
At a glance
Conditions
NCT06937242
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Hanger Inc.
Austin, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Shane R. Wurdeman, PhD · PRINCIPAL_INVESTIGATOR · Hanger Institute for Clinical Research and Education
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Prosthetic Limb Users Survey of Fall-Related Self-Efficacy (PLUS-F-SEF)Collected at baseline, 1-month, 3-month, 6-month, 9-month, and 12-month assessments.
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)Collected at baseline, 1-month, 3-month, 6-month, 9-month, and 12-month assessments.
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)Collected at baseline, 1-month, 3-month, 6-month, 9-month, and 12-month assessments.
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)Collected at baseline, 1-month, 3-month, 6-month, 9-month, and 12-month assessments.
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.
- Number of Reported Falls and Near-Fall EventsCollected every two weeks starting at baseline up to 12 months
Participants will be contacted every 2 weeks starting at baseline through study completion to determine whether they experienced a fall event (either a fall or near-fall). For each event experienced, participants will be asked to report the details of that event using the Lower Limb Prosthesis User Fall Event Survey we developed in a prior study. This instrument asks respondents to report the activity, surroundings, situation, mechanics, and consequences of each event. Fall events will be scored as the total number of falls, near-falls, and all fall events experienced. The details of the events are descriptive in nature and will be used to characterize the falls experienced by the participant.