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

Part of paid clinical trials in Austin, Texas.

Sponsor
Hanger Institute for Clinical Research and Education, LLC
Study ID
NCT06937242
Status
Recruiting
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Conditions

  • Amputation
  • Amputation; Traumatic, Leg: Thigh, Between Hip and Knee
  • Limb; Absence, Congenital, Lower
  • Lower Limb Amputation Above Knee
  • Lower Limb Amputation Above Knee (Injury)
  • Prosthesis User

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ottobock C-Leg 4 Microprocessor Knee — DEVICE
    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 — DEVICE
    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 Details

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.

Key Dates

Start date
Jul 11, 2025
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: MPK (Ottobock C-Leg 4 or Ottobock Kenevo)
    The MPK provided to each participant in the intervention arm will be determined by the manufacturer's recommended patient-selection criteria.
  • No Intervention: nMPK
    Participants in the control arm of the trial will remain in their prescribed non-microprocessor knee (nMPK) prosthesis

Primary Outcome Measure

Prosthetic Limb Users Survey of Fall-Related Self-Efficacy (PLUS-F-SEF) [ Time Frame: Collected at baseline, 1-month, 3-month, 6-month, 9-month, and 12-month assessments. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hanger Inc.AustinTexas78758
Shane R. Wurdeman, PhD
[email protected]
281-829-4746
Bretta L. Fystra, PhD
[email protected]
512-994-6685
Shane R. Wurdeman, PhD (PRINCIPAL_INVESTIGATOR)

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Hanger Inc.· Austin, TX

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