Recruiting

C-leg vs. Bio LegBio Leg: Advancing Mobility (BAM)

Sponsor:

University of Florida

Code:

NCT07613502

Conditions

Amputation of Lower Limb Above Knee

Amputee

Amputation

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Not accepted

Interventions

Bio Leg

Study Details

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 (micro-processor controlled prosthetic knee; 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

Study ID

NCT07613502

Start date

Jun 1, 2026

Status verified date

May, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

Adults 40 to 70 years of age
Unilateral transfemoral amputation > 1 year
K3 or K4 ambulator (based on the K classification system) 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

Exclusion Criteria:

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

Study Design

Enrollment

12 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Bio Leg

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.

Primary outcome measure

Change in 6-Minute Walk Test (6MWT) [ Time Frame: Baseline, 4-6 weeks ]
Change in Interlimb Symmetry (Ground Reaction Forces) [ Time Frame: Baseline, 4-6 weeks ]
Change in Metabolic Efficiency (O2/kg/m) [ Time Frame: Baseline, 4-6 weeks ]

Central Contacts and Locations

Central contacts

Emily J Fox, PT, DPT, MHS, PhD

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

Joshua C Encarnacion, BS

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

Locations

Brooks Rehabilitation

Recruiting

Jacksonville, Florida, United States, 32216

More Information

Sponsor

University of Florida

Last update posted

Jul 6, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-07-06.