Bio Leg: Advancing Mobility for people with above-knee amputations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This within-subject study compares mobility with a Bio Leg powered knee to a current C-leg prosthesis in adults with unilateral transfemoral amputation. Participants are evaluated under two conditions (Bio Leg vs. C-leg) to measure walking performance, biomechanics, and energy use in real-world tasks. Outcomes focus on movement quality, efficiency, and stability to determine potential benefits for prescription and rehabilitation decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

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

Where it's running

• Brooks Rehabilitation
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Emily J Fox, PT, DPT, MHS, PhD — University of Florida & Brooks Rehabilitation
• Study coordinator: Emily J Fox, PT, DPT, MHS, PhD
• Email: ejfox@phhp.ufl.edu
• Phone: 904-742-2500

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Understanding the impact of powered prosthetics on walking for transfemoral amputees

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• Hand prosthesis usability and performance evaluation for people with upper limb absence

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.