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Bio Leg: Advancing Mobility

NCT07613502 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-05-29

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Brooks Rehabilitation

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • Emily J Fox, PT, DPT, MHS, PhD · University of Florida & Brooks Rehabilitation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-07-31
Completion
2028-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07613502 on ClinicalTrials.gov