Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators

Condition(s) studied

Investigational drug(s) / intervention(s)

Ottobock C-Leg 4 Microprocessor Knee: Subjects 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: Subjects 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• 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 Events — Collected 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.

Trial sites (1)

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