AmputationNCT06433648
Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait
A study testing Ottobock CLeg4 + Ottobock foot, SRALAB Hybrid Knee + Polycentric Ankle and SRALAB Hybrid Knee + Passive Ankle in people with Amputation and Amputation, Traumatic, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Amputation, Amputation, Traumatic, Amputation of Knee
- What is being tested?
- Ottobock CLeg4 + Ottobock foot, SRALAB Hybrid Knee + Polycentric Ankle and SRALAB Hybrid Knee + Passive Ankle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Suzanne Finucane, MS, PTA, 312-238-0937, sfinucane@sralab.org
Levi Hargrove, PhD, 312-238-2080, lhargrove@sralab.org
About this study
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Ottobock CLeg4 + Ottobock foot, SRALAB Hybrid Knee + Polycentric Ankle, SRALAB Hybrid Knee + Passive Ankle, Ottobock CLeg 4 + Polycentric Ankle
- Medical subject headings
- Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ottobock CLeg4 + Ottobock footDevice
Commercially available Ottobock CLeg 4 microprocessor knee unit and Ottobock foot.
SRALAB Hybrid Knee + Polycentric AnkleDevice
Experimental powered prosthesis: SRALAB Hybrid Knee and powered polycentric ankle.
SRALAB Hybrid Knee + Passive AnkleDevice
Experimental powered prosthesis: SRALAB Hybrid Knee and passive ankle.
Ottobock CLeg 4 + Polycentric AnkleDevice
Commercially available Ottobock CLeg 4 prosthetic knee and SRALAB powered polycentric ankle.
| Study group | Role | What they receive |
|---|---|---|
| Transfemoral Amputee participants: Ottobock Cleg4 + Ottobock foot; Hybrid Knee + Polycentric Ankle | Active comparator | Participant 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. Receives: Device: Ottobock CLeg4 + Ottobock foot; Device: SRALAB Hybrid Knee + Polycentric Ankle |
| Transfemoral Amputee participants: Ottobock CLeg4 + Polycentric Ankle, Hybrid Knee + Passive Ankle | Experimental | For 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. Receives: Device: SRALAB Hybrid Knee + Passive Ankle; Device: Ottobock CLeg 4 + Polycentric Ankle |
| Transfemoral Amputee participants: SRALAB Hybrid knee + Polycentric Ankle, Ottobock Cleg4 + OB foot | Experimental | During 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. Receives: Device: Ottobock CLeg4 + Ottobock foot; Device: SRALAB Hybrid Knee + Polycentric Ankle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
Measured: 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)
The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults.
Measured: 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)
A test of dynamic balance and coordination that clinically assesses the participant's ability to step over objects forward, sideways, and backwards.
Measured: Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.
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.
Measured: Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 May 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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 transfemoral amputees with limited community mobility. Aim 1: measure functional performance of transfemoral 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).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Levi Hargrove, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433648
- Sponsor's protocol ID
- STU00217960
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18295618Gailey 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.
PubMed 7991365Hafner 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.
PubMed 12084537Burger 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.
PubMed 9141124Fey 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.
PubMed 27170878Adamczyk 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.
PubMed 25222950
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait
- ClinicalTrials.gov ID
- NCT06433648
- Acronym / sponsor ID
- STU00217960
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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 transfemoral amputees with limited community mobility. Aim 1: measure functional performance of transfemoral 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).
| Arm | Type | Receives |
|---|---|---|
| Transfemoral Amputee participants: Ottobock Cleg4 + Ottobock foot; Hybrid Knee + Polycentric Ankle | Active comparator | Device: Ottobock CLeg4 + Ottobock foot, Device: SRALAB Hybrid Knee + Polycentric AnkleParticipant 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 | Experimental | Device: SRALAB Hybrid Knee + Passive Ankle, Device: Ottobock CLeg 4 + Polycentric AnkleFor 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 | Experimental | Device: Ottobock CLeg4 + Ottobock foot, Device: SRALAB Hybrid Knee + Polycentric AnkleDuring 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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ottobock CLeg4 + Ottobock footCommercially available Ottobock CLeg 4 microprocessor knee unit and Ottobock foot. | Device | Transfemoral Amputee participants: Ottobock Cleg4 + Ottobock foot; Hybrid Knee + Polycentric Ankle, Transfemoral Amputee participants: SRALAB Hybrid knee + Polycentric Ankle, Ottobock Cleg4 + OB foot |
| SRALAB Hybrid Knee + Polycentric AnkleExperimental powered prosthesis: SRALAB Hybrid Knee and powered polycentric ankle. | Device | Transfemoral Amputee participants: Ottobock Cleg4 + Ottobock foot; Hybrid Knee + Polycentric Ankle, Transfemoral Amputee participants: SRALAB Hybrid knee + Polycentric Ankle, Ottobock Cleg4 + OB foot |
| SRALAB Hybrid Knee + Passive AnkleExperimental powered prosthesis: SRALAB Hybrid Knee and passive ankle. | Device | Transfemoral Amputee participants: Ottobock CLeg4 + Polycentric Ankle, Hybrid Knee + Passive Ankle |
| Ottobock CLeg 4 + Polycentric AnkleCommercially available Ottobock CLeg 4 prosthetic knee and SRALAB powered polycentric ankle. | Device | Transfemoral Amputee participants: Ottobock CLeg4 + Polycentric Ankle, Hybrid Knee + Passive Ankle |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Background: PubMed 18295618Ziegler-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.
- Background: PubMed 7991365Gailey 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.
- Background: PubMed 12084537Hafner 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.
- Background: PubMed 9141124Burger 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.
- Background: PubMed 27170878Fey 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.
- Background: PubMed 25222950Adamczyk 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.
Related trials for Amputation
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
RecruitingObservational study
CNS Changes Following Upper Limb Loss
Amputation, Congenital, Upper Limb; Amelia
Recruiting
Hand Prosthesis Usability and Performance
Amputation
Recruiting
E-Socket, Diagnostic Monitoring
Trans-Tibial Amputation
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ottobock CLeg4 + Ottobock foot, SRALAB Hybrid Knee + Polycentric Ankle and SRALAB Hybrid Knee + Passive Ankle in people with Amputation and Amputation, Traumatic, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzanne Finucane, MS, PTA (312-238-0937, sfinucane@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06433648, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.