Trials / Recruiting

RecruitingNCT06937242

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

Fall-related Health Outcome in Lower Limb Prosthesis Users: A Pragmatic Clinical Trial to Assess Effectiveness of Microprocessor-controlled Prosthetic Knees

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 100 (estimated)

Sponsor: Hanger Institute for Clinical Research and Education, LLC · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

This study aims to assess the effects of microprocessor-controlled prosthetic knees on fall-related health outcomes in prosthesis users classified as limited community ambulators. This study also seeks to expand the existing research on the potential microprocessor-controlled prosthetic knees (MPKs) have on improving health outcomes for patients who are classified as limited community ambulators (i.e., Medicare Functional Level K2). The investigators will examine whether the anticipated reduction in falls in K2 users is accompanied by improvements in fall-related health outcomes like fall-related anxiety, fall-related self-efficacy, fall-related avoidance behaviors, fall-related interference, and fewer falls. Investigators will also examine whether MPK use in the K2 population leads to increased mobility, increased walking speed, and improvements in health-related quality of life. A 12-month, pragmatic randomized control trial (pRCT) will be conducted to assess whether MPKs improve fall-related health outcomes in unilateral, transfemoral or knee disarticulation prosthesis users classified as limited community ambulators. Patients will be invited to participate in the trial as a part of their routine prosthetic care. If a patient agrees to participate and is eligible, a follow-up appointment will be scheduled, and the patient will be consented by the research study team. Participants will then be randomized to the intervention or control group. Participants in the control arm of the trial will remain in their prescribed prosthesis with a non-microprocessor knee (nMPK). Participants randomized to the intervention arm of the trial will have their nMPK exchanged for either a stance-and-swing MPK (Ottobock C-Leg 4) or a stance-only MPK (Ottobock Kenevo). The MPK provided to each participant in the intervention arm will be determined by the manufacturer's recommended patient-selection criteria. Transfemoral prosthesis users walking up to 0.83m/s (3km/hr) in the 2-minute walk test (2MWT) will receive a stance-only MPK (Kenevo), while participants walking more than 0.83m/s in the 2MWT will receive a stance-and-swing MPK (C-Leg 4). Study participants will wear the knee for 12 months. Each participant will be assessed at baseline (after enrollment and randomization), and 1-, 3-, 6-, 9-, and 12-months after baseline. The baseline and 12-month assessments will be the primary study time points. T-scores on the Prosthetic Limb Users Survey of Fall-Related Health (PLUS-F) and number of fall events experienced over the prior year will serve as the primary endpoints. Participants will complete a selected set of performance-based tests and standardized self-report surveys. In addition to the outcome measures noted, investigators will collect sociodemographic, health, amputation, fall history, and prosthesis information by self-report in order to characterize study participants and assess the comparability of the study groups. Fall-related health outcomes (e.g. fall-related self-efficacy and fall-related interference) will be measured using new PLUS-F instruments as well as existing measures that measure fall-related outcomes. We will also co-administer the Prosthetic Limb Users Survey of Mobility (PLUS-M) to assess participants' prosthesis-related mobility. Walking speed, mobility, endurance, and quality of life will be measured. For the 6- and 12-month assessments, we will also collect the hours of wear and hours of activity in the prosthesis. Participants in both groups will receive education and training specific to their prosthetic knee between assessment 1 (baseline) and assessment 2 (one-month follow-up). Training will consist of 1 to 4 sessions to facilitate participants' use of their assigned prostheses. The number of sessions will be determined by the ability of each participant to explain and/or perform specified tasks. A standardized protocol and training checklist will be developed by our team Physical Therapist specific to each condition in collaboration with the knees' manufacturer (Ottobock). Every 2 weeks, throughout the 12 months of patient participation, the number of falls and near-fall events, including the event, injury, treatment and/or hospitalization, and whether the falls occurred while wearing the prosthesis, will be collected.

Conditions

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

Start date: 2025-07-11
Primary completion: 2027-02-01
Completion: 2027-02-01
First posted: 2025-04-22
Last updated: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT06937242. Inclusion in this directory is not an endorsement.