Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2023
CompletedFirst Submitted
Initial submission to the registry
May 16, 2024
CompletedFirst Posted
Study publicly available on registry
May 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
May 30, 2024
May 1, 2024
5.2 years
May 16, 2024
May 28, 2024
Conditions
Outcome Measures
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.
Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.
Secondary Outcomes (4)
6 Minute Walk Test (6MWT)
Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.
Timed Up and Go (TUG)
Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.
Four Square Step Test (FSST)
Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.
Metabolic Testing
Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38
Study Arms (3)
Transfemoral Amputee participants: Ottobock Cleg4 + Ottobock foot; Hybrid Knee + Polycentric Ankle
ACTIVE COMPARATORParticipant is fit with the commercially available device (Ottobock Cleg 4/Ottobock foot), they will receive standard of care clinical training for 3-4 sessions over 4 weeks, plus 1 session for outcome assessments. Participant is then fit with the SRALAB Hybrid knee and SRALAB Polycentric Ankle prosthesis, they again will receive clinical training for 3-4 sessions over 4 weeks, plus 1 session for outcome assessments.
Transfemoral Amputee participants: Ottobock CLeg4 + Polycentric Ankle, Hybrid Knee + Passive Ankle
EXPERIMENTALFor this arm, transfemoral amputees will participate in an AB/BA randomized crossover study. Before each arm of the cross-over, baseline data will be taken with the Ottobock Cleg 4/Ottobock foot or their clinically prescribed microprocessor knee unit/foot. Condition A is CLeg + Polycentric Ankle Condition B is SRALab Hybrid knee + Passive Ankle Subjects will participate in 2 sessions over 2 weeks, each lasting 2-3 hours to have the device tuned for the specific condition (A or B). On the third week, they will participate in 2 visits to complete functional outcome measures, biomechanical and metabolic assessments. They will then switch conditions, and repeat the protocol for the second condition. There will not be a washout period between conditions, but subjects will complete outcome measures with the Ottobock Cleg 4/Ottobock foot or their clinically prescribed microprocessor knee unit/foot prior to each arm of the crossover to obtain baseline data.
Transfemoral Amputee participants: SRALAB Hybrid knee + Polycentric Ankle, Ottobock Cleg4 + OB foot
EXPERIMENTALDuring this arm, participants will receive intensive clinical training with the SRALAB Hybrid knee + Polycentric Ankle twice per week over 8 weeks, lasting 2-3 hours. Training will include patient-driven therapy to achieve participants' individual therapy goals, functional mobility and community skills. At the end of the 8-week training period, subjects will complete the same set of functional outcome measures, biomechanical and metabolic assessments in previous arms. To complete this arm, participants will again complete training and outcome measures with the Ottobock Cleg4/Ottobock or their clinically prescribed microprocessor knee unit/foot over 3 visits.
Interventions
Commercially available Ottobock CLeg 4 microprocessor knee unit and Ottobock foot.
Experimental powered prosthesis: SRALAB Hybrid Knee and powered polycentric ankle.
Experimental powered prosthesis: SRALAB Hybrid Knee and passive ankle.
Commercially available Ottobock CLeg 4 prosthetic knee and SRALAB powered polycentric ankle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
Related Publications (6)
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.
PMID: 18295618BACKGROUNDGailey 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.
PMID: 7991365BACKGROUNDHafner BJ, Sanders JE, Czerniecki J, Fergason J. Energy storage and return prostheses: does patient perception correlate with biomechanical analysis? Clin Biomech (Bristol). 2002 Jun;17(5):325-44. doi: 10.1016/s0268-0033(02)00020-7.
PMID: 12084537BACKGROUNDBurger 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.
PMID: 9141124BACKGROUNDFey 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.
PMID: 27170878BACKGROUNDAdamczyk 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.
PMID: 25222950BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Scientific Chair, Center for Bionic Medicine
Study Record Dates
First Submitted
May 16, 2024
First Posted
May 30, 2024
Study Start
May 1, 2023
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2029
Last Updated
May 30, 2024
Record last verified: 2024-05