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
Qualifiers
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
Treatments tested in this trial
- Ottobock CLeg4 + Ottobock foot
- SRALAB Hybrid Knee + Polycentric Ankle
- SRALAB Hybrid Knee + Passive Ankle
- Ottobock CLeg 4 + Polycentric Ankle
Treatment groups
20 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov