Bio Leg: Advancing Mobility

NCT07613502 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB202600203
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amputation of Lower Limb Above Knee; Amputee; Amputation

Keywords

Amputation; Above Knee Amputation; AKA; Prosthetic Use; Prostheses; C-leg; BioLeg; Amputee

Outcome Measures

Primary Outcomes (3)

• Change in 6-Minute Walk Test (6MWT)

  The distance that a patient should walk based on their height, weight, age, and gender. Performance assessment of walking endurance for 6 minutes. An increase in the number of meters walked during this assessment reflects an improvement in walking endurance.

  Baseline, 4-6 weeks

• Change in Interlimb Symmetry (Ground Reaction Forces)

  A direct measure of vertical ground reaction forces during the rising phase of a sit-to-stand task (measured in Newtons) using standard force plates embedded in the floor. Increased symmetry in ground reaction forces between the lower limbs reflects improved equalization of weight distribution between the limbs.

  Baseline, 4-6 weeks

• Change in Metabolic Efficiency (O2/kg/m)

  A direct measure assessed during the six-minute walk test. Metabolic efficiency is determined by the energy cost of transport, defined as oxygen consumption per unit body weight and distance walked (O₂/kg/m), which accounts for the individual's weight and walking speed. Improved metabolic efficiency reflects enhanced oxygen delivery and utilization during walking.

  Baseline, 4-6 weeks

Study Arms (2)

C-Leg

NO INTERVENTION

The first assessment will involve testing the participant with their current C-leg microprocessor prosthesis.

Bio Leg

EXPERIMENTAL

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.

Device: Bio-Leg

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.

Bio Leg

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 40 to 70 years of age
• Unilateral transfemoral amputation \> 1 year
• K3 or K4 ambulator and able to walk with no greater assistances than a single point cane
• Current microprocessor-controlled prosthesis (C-leg) user with \> 6 months experience and able to walk without a device of using a single point cane
• Able to give informed consent

You may not qualify if:

• Severe cardiovascular condition or other disease limiting study participation
• Skin lesions or wounds, acute or unstable fracture, diagnosis of osteoarthritis or bone impairments affecting safe participation in walking activities
• Residual limb dysfunction (i.e. joint contracture) limiting mobility or study participation
• Pain that limits walking of participation in walking activities
• Current participation in rehabilitation to address walking function

Sponsors & Collaborators

• University of Florida: lead
• Brooks Rehabilitation: collaborator

Study Sites (1)

Brooks Rehabilitation

Jacksonville, Florida, 32216, United States

Location

Study Officials

• Emily J Fox, PT, DPT, MHS, PhD

  University of Florida & Brooks Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily J Fox, PT, DPT, MHS, PhD

CONTACT

904-742-2500; ejfox@phhp.ufl.edu

Joshua C Encarnacion, BS

CONTACT

904-345-8969; Joshua.Encarnacion@brooksrehab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within-subject crossover design

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)