Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorShirley Ryan AbilityLab
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Ottobock CLeg4 + Ottobock foot
DeviceCommercially available Ottobock CLeg 4 microprocessor knee unit and Ottobock foot.
SRALAB Hybrid Knee + Polycentric Ankle
DeviceExperimental powered prosthesis: SRALAB Hybrid Knee and powered polycentric ankle.
SRALAB Hybrid Knee + Passive Ankle
DeviceExperimental powered prosthesis: SRALAB Hybrid Knee and passive ankle.
Ottobock CLeg 4 + Polycentric Ankle
DeviceCommercially available Ottobock CLeg 4 prosthetic knee and SRALAB powered polycentric ankle.
Treatment groups
20 Participants
are divided into 3 treatment groupsGroup A: Transfemoral Amputee participants: Ottobock Cleg4 + Ottobock foot; Hybrid Knee + Polycentric AnkleActive comparator 2 interventions
Group B: Transfemoral Amputee participants: Ottobock CLeg4 + Polycentric Ankle, Hybrid Knee + Passive AnkleExperimental treatment 2 interventions
Group C: Transfemoral Amputee participants: SRALAB Hybrid knee + Polycentric Ankle, Ottobock Cleg4 + OB footExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Amputee Mobility Predictor with Prosthesis (AMPRO) score
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.
Time frame
Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.Secondary outcomes
1
6 Minute Walk Test (6MWT)
The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
Time frame
Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.2
Timed Up and Go (TUG)
The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults.
Time frame
Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.3
Four Square Step Test (FSST)
A test of dynamic balance and coordination that clinically assesses the participant's ability to step over objects forward, sideways, and backwards.
Time frame
Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.4
Metabolic Testing
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.
Time frame
Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov