Functional Outcomes in Dysvascular Transfemoral Amputees
Completed · Not applicable
Conditions studied: Transfemoral Amputation, Unilateral Traumatic Amputation of Leg at or Above Knee
In brief
In older adults, poor circulation in the lower extremities leads to serious health complications including limb loss. In addition, individuals with dysvascular disease also suffer from other co-morbidities like diabetes, coronary and cerebrovascular disease. An individual with a transfemoral (TF) amputation is usually fitted with a prosthetic limb to assist with function, including a prosthetic knee and a prosthetic foot. Currently, dysvascular amputees are given a prosthetic knee based on the basic expectation that they will be functionally stable. This consideration does not address higher levels of function like walking at multiple speeds and over uneven ground. Also, dysvascular amputees are not able to counteract their co-morbidities with a more active lifestyle. Walking is less energy efficient; their traditional prostheses may cause early onset of fatigue and induce a fear of falling. Newer microprocessor knees enable patients with transfemoral amputations to walk on different surfaces and at multiple cadences through better control in swing and stance phases of gait. The impact of the functional differences in the prostheses is not clear and requires additional investigation to clarify the choice of the most appropriate functional prosthesis. The purpose of this study is to compare the functional outcomes with the traditional mechanical knee versus the microprocessor knee (C-leg) in transfemoral amputees.
Key facts
- Study ID
- NCT01537211
- Run by
- Shirley Ryan AbilityLab
- People needed
- 10
- Starts
- 2011-08-01
- Expected to finish
- 2019-04-01
- Last updated by the study team
- 2019-09-06
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males or females with dysvascular transfemoral amputations
- 6 months or more post prosthetic fitting
- Homebound or limited community ambulators post amputation
- Ability to walk > 50m in a 2 min walk test
You may not qualify if…
- Traumatic, cancer or genetic amputation
- Co-morbidity that completely prevents physical activity
- Significant skin lesions/ulcers on stump that prevent fitting of prosthesis
- Cognitive deficits or visual impairments that would impair their ability to give informed consent or to follow simple instructions during experiment
Where it is running
- Rehabilitation Institute of Chicago, 345 E Superior St — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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