What this study is
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.
What's being tested
- Bio Leg
Intervention · 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
- Official title
- Adaptive Mobility Technology: A Comparative Study of C-Leg and Bio Leg
- Sponsor
- University of Florida
- Conditions
- Amputation of Lower Limb Above Knee · Amputee · Amputation
- Enrolling
- 12 people
- Starts
- 2026-06-01
- Est. completion
- 2028-07
- Design
- Open-label, non-randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Adults 40 to 80 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
You can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBrooks Rehabilitation
Jacksonville, Florida, United States
Recruiting
Study team
Sponsor
University of Florida
Study ID IRB202600203
Principal investigator
Emily J Fox, PT, DPT, MHS, PhD
University of Florida & Brooks Rehabilitation
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.