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Bio Leg: Advancing Mobility (BAM)

21. maj 2026 opdateret af: University of Florida

Adaptive Mobility Technology: A Comparative Study of C-Leg and Bio Leg

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Although microprocessor-controlled knees (MPKs) such as the C-Leg have demonstrated clear benefits over non-microprocessor-controlled prosthetic knees, it remains unclear whether powered knee assistance provides additional advantages in movement quality, metabolic efficiency, and limb loading during walking adaptability tasks.

This study directly addresses this gap by comparing mobility using the Bio Leg to mobility with the C-Leg using outcome measures that reflect real-world mobility challenges.

By generating objective evidence on whether powered knee assistance improves biomechanics, efficiency, and stability beyond that achieved with an established MPK, this study will inform prosthetic prescription, rehabilitation strategies, and payer decision-making. Given the growing population of individuals living with transfemoral amputation, identifying technologies that support safe, efficient, and confident mobility has important implications for community participation, long-term musculoskeletal health, and quality of life.

This study uses a within-subject repeated-measures design in which each participant is assessed under two conditions: current prosthesis and the Bio Leg prosthesis. All primary and secondary outcomes will be analyzed as within-participant differences, with each participant serving as their own control.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

12

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Emily J Fox, PT, DPT, MHS, PhD
  • Telefonnummer: 904-742-2500
  • E-mail: ejfox@phhp.ufl.edu

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32216
        • Brooks Rehabilitation

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: C-Leg
The first assessment will involve testing the participant with their current C-leg microprocessor prosthesis.
Eksperimentel: 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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in 6-Minute Walk Test (6MWT)
Tidsramme: Baseline, 4-6 weeks
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)
Tidsramme: Baseline, 4-6 weeks
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)
Tidsramme: Baseline, 4-6 weeks
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Florida

Samarbejdspartnere

Brooks Rehabilitation

Efterforskere

  • Ledende efterforsker: Emily J Fox, PT, DPT, MHS, PhD, University of Florida & Brooks Rehabilitation

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. juli 2028

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

21. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • IRB202600203

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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