Bio Leg: Advancing Mobility

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
University of Florida
Study ID
NCT07613502
Status
Not Yet Recruiting

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Conditions

  • Amputation
  • Amputation of Lower Limb Above Knee
  • Amputee

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Bio-Leg — DEVICE
    After completing biomechanics and clinical testing at Pre Assessment with their C-Leg, participants will be fitted with a Bio-Leg prosthesis at the prosthetist clinic. The participant will train and use the Bio-Leg prosthesis during a 4-6 week acclimation period. The participant will then complete the same biomechanics and clinical testing at Post Assessment.

Study Details

Following transfemoral amputation, regaining functional mobility, particularly the ability to navigate curbs, ramps, long distances, and the ability to stand is challenging and often unattainable. Use of advanced prosthetic limb technology can dramatically influence mobility outcomes. The purpose of this study is to compare walking function in individuals with transfemoral amputations who are current users of the C-leg (current clinical standard) to function achieved when using the Bio Leg powered micro-processor prosthetic knee.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • No Intervention: C-Leg
    The first assessment will involve testing the participant with their current C-leg microprocessor prosthesis.
  • Experimental: Bio Leg
    After the Bio Leg fitting, the participant will exclusively wear the Bio Leg knee component for an acclimation period that will be a minimum of 4 weeks and up to 6 depending on participant's schedule and comfort/ease of using the device. Each participant will complete a minimum of 2 and up to 4 physical therapy sessions during the acclimation period. These physical therapy sessions will involve standard physical therapy training for use of a prosthetic limb after amputation. Following the acclimation period, the participant will complete the second assessment, which will mirror the first assessment.

Primary Outcome Measure

Change in 6-Minute Walk Test (6MWT) [ Time Frame: Baseline, 4-6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brooks RehabilitationJacksonvilleFlorida32216-

Find similar trials in Jacksonville, FL

By research site
Brooks Rehabilitation· Jacksonville, FL

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