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NCT01537211 · ClinicalTrials.gov registry record · NA
Functional Outcomes in Dysvascular Transfemoral Amputees
A NA study, sponsored by Shirley Ryan AbilityLab.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT01537211 is a NA study that has completed, run by Shirley Ryan AbilityLab. The registered enrollment target is 10 participants.
The verdict
NCT01537211, a NA study, has completed, sponsored by Shirley Ryan AbilityLab.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE C leg compared to subject's mechanical leg (Otto Bock)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-08 |
| Est. Completion | 2019-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01537211
The ClinicalTrials.gov registry entry for NCT01537211 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shirley Ryan AbilityLab, which has 138 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which C leg compared to subject's mechanical leg (Otto Bock) is the first listed.
NCT01537211 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01537211 about?
NCT01537211 is a clinical study titled "Functional Outcomes in Dysvascular Transfemoral Amputees". 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) am...
What is the current status of trial NCT01537211?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2011-08. Estimated completion is 2019-04.
What interventions are being tested in trial NCT01537211?
The interventions under investigation include: C leg compared to subject's mechanical leg (Otto Bock) (DEVICE).
Who is sponsoring clinical trial NCT01537211?
This trial is sponsored by Shirley Ryan AbilityLab, which has 138 total clinical trials registered on ClinicalTrials.gov.
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