Amputation Clinical Trial
Official title:
Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait
NCT number | NCT06433648 |
Other study ID # | STU00217960 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2023 |
Est. completion date | June 30, 2029 |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | June 30, 2029 |
Est. primary completion date | June 30, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Shirley Ryan AbilityLab | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Shirley Ryan AbilityLab |
United States,
Adamczyk PG, Kuo AD. Mechanisms of Gait Asymmetry Due to Push-Off Deficiency in Unilateral Amputees. IEEE Trans Neural Syst Rehabil Eng. 2015 Sep;23(5):776-85. doi: 10.1109/TNSRE.2014.2356722. Epub 2014 Sep 12. — View Citation
Burger H, Marincek C. The life style of young persons after lower limb amputation caused by injury. Prosthet Orthot Int. 1997 Apr;21(1):35-9. doi: 10.3109/03093649709164528. — View Citation
Fey NP, Simon AM, Young AJ, Hargrove LJ. Controlling Knee Swing Initiation and Ankle Plantarflexion With an Active Prosthesis on Level and Inclined Surfaces at Variable Walking Speeds. IEEE J Transl Eng Health Med. 2014 Jul 25;2:2100412. doi: 10.1109/JTEHM.2014.2343228. eCollection 2014. — View Citation
Gailey RS, Wenger MA, Raya M, Kirk N, Erbs K, Spyropoulos P, Nash MS. Energy expenditure of trans-tibial amputees during ambulation at self-selected pace. Prosthet Orthot Int. 1994 Aug;18(2):84-91. doi: 10.3109/03093649409164389. — View Citation
Hafner BJ, Sanders JE, Czerniecki J, Fergason J. Energy storage and return prostheses: does patient perception correlate with biomechanical analysis? Clin Biomech (Bristol, Avon). 2002 Jun;17(5):325-44. doi: 10.1016/s0268-0033(02)00020-7. — View Citation
Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38. | |
Secondary | 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. | Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38. | |
Secondary | Timed Up and Go (TUG) | The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults. | Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38. | |
Secondary | 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. | Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38. | |
Secondary | Metabolic Testing | Subjects will be instrumented with the COSMEDĀ® 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. | Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38 |
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