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NCT Number: NCT06433648

Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait

The goal of this study is to understand how providing power at the knee or ankle individually, or providing power at both the knee and ankle, impacts ambulation for K2 level transfemoral amputees.

Aim 1: measure functional performance of K2 level ambulators when using a commercially available passive microprocessor knee prosthesis (Ottobock Cleg/Ottobock foot) or a powered knee and ankle prosthesis (SRALab Hybrid Knee and SRAlab Polycentric Powered Ankle.

Aim 2: Participants will be evaluated on the contribution of adding power at the knee only or the ankle only.

Aim 3: The investigators will evaluate the functional performance after intensive clinical gait training on the powered knee and ankle prosthesis (SRALab Hybrid Knee and SRALab Polycentric Powered Ankle).

Our hypothesis is that providing powered componentry will improve function and that intensive training will magnify those improvements.

Recruiting

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Amputation of the lower limb causes profound disability, significantly limiting mobility, independence, and the ability to pursue employment or leisure activities. Nearly 90% of all lower limb amputations in the United States occur in older persons, mostly due to vascular disease, and this population is expected to triple by 2050. After lower limb loss, individuals walk more slowly and more asymmetrically are less stable, and expend more metabolic energy during walking than persons with intact limbs. Even when using state-of-the-art microprocessor-controlled prostheses (typically a microprocessor knee with a passive ankle), persons with transfemoral amputations expend approximately 60% more energy than able-bodied individuals during ambulation. In addition to the physical limitations caused by the amputation, the increased energy requirements affect performance of everyday activities, including getting up out of a chair or off the toilet, or stepping up or down a curb.

Most commercially available prosthetic legs are passive. The movement of a passive prosthetic joint relies on the properties of its mechanical components, such as hydraulic or pneumatic valves or sliding joints, together with compensatory adjustments made by the user. Since these computerized prostheses are passive, the user cannot efficiently negotiate stairs, an incline, or the numerous other functions that require net knee and/or ankle power.

Powered prostheses can actively generate joint torque, allowing easy and efficient performance of more demanding activities, such as ascending stairs and hills. Powered knees and ankles, may allow for better outcomes in both older and younger individuals with transfemoral amputation; this powered componentry may enable more energy efficient walking, allow users to stand up from a seated position with ease, and enable them to walk across more challenging terrains-such as up and down hills, ramps, and stairs-safely and with more normal and symmetric gait kinematics and kinetics.

This study will demonstrate the functional benefits of adding power at an individual joint. This knowledge will be critical for prioritizing future device development and will provide valuable information for clinicians and individuals on selecting appropriate componentry for transfemoral K2 amputees.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 18-95
  • A unilateral transfemoral amputation
  • At least 6 months since definitive prosthesis fitting
  • Able to walk 50 meters (55 yards) with a prosthesis without the assistance of another person.
  • Medically cleared by physician to participate in study
  • English speaking

Exclusion criteria

  • Weight greater than 250 pounds
  • Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
  • Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.
  • Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers.

Treatment and study plan

Ottobock CLeg4 + Ottobock foot

Device

Commercially available Ottobock CLeg 4 microprocessor knee unit and Ottobock foot.

SRALAB Hybrid Knee + Polycentric Ankle

Device

Experimental powered prosthesis: SRALAB Hybrid Knee and powered polycentric ankle.

SRALAB Hybrid Knee + Passive Ankle

Device

Experimental powered prosthesis: SRALAB Hybrid Knee and passive ankle.

Ottobock CLeg 4 + Polycentric Ankle

Device

Commercially available Ottobock CLeg 4 prosthetic knee and SRALAB powered polycentric ankle.

Primary outcomes

  1. Amputee Mobility Predictor with Prosthesis (AMPRO) score

    Time frame: Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.

    The AMPRO measures the ambulatory potential of lower limb amputees. It is used to assess functional mobility through a standardized sequence of mobility tests while using a prosthesis. Individual tasks are scored and combined, resulting in a total assessment score out of a possible 47; the minimum score is zero. Higher scores indicate better mobility.

    The AMPPRO is a reliable performance measure that has been validated for those with lower limb loss; it measures several functional mobility tasks that are needed during activities of daily living; it has been used to identify limitations in prosthetic mobility, including tasks that require both vertical mobility (sit/stand), horizontal mobility (walking), and balance. The AMPPRO scores have been shown to differentiate between Medicare K-levels and to provide information to guide therapeutic exercise techniques and document change after clinical instruction.

Secondary outcomes

  1. 6 Minute Walk Test (6MWT)

    Time frame: Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.

    The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.

  2. Timed Up and Go (TUG)

    Time frame: Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.

    The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults.

  3. Four Square Step Test (FSST)

    Time frame: Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.

    A test of dynamic balance and coordination that clinically assesses the participant's ability to step over objects forward, sideways, and backwards.

  4. Metabolic Testing

    Time frame: Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38

    Subjects will be instrumented with the COSMED® K5 system (COSMED, Rome, Italy). Baseline metabolic data prior to each walking bout will be recorded for 2 minutes of sitting and quiet rest. Metabolic data will then be collected during 6 minutes of walking at a constant self-selected walking velocity on a treadmill. After each walking bout, subjects will rest for 20 minutes to allow their heart rate to return to their baseline level.

Study contacts

Contact information is provided by the study sponsor or research team.

Levi Hargrove, PhD

CONTACT

[email protected]

312-238-2080

Suzanne Finucane, MS, PTA

CONTACT

[email protected]

312-238-0937

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
May 30, 2024
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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