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NCT02440711 · ClinicalTrials.gov registry record · NA
Evaluation of a Modified Running-specific Prosthetic Foot
A NA study of Transtibial Amputation, sponsored by University of Washington.
- Completed
- Registry status
- NA
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT02440711: Completed NA study of Transtibial Amputation, sponsored by University of Washington.
NCT02440711 is a NA study of Transtibial Amputation that has completed, run by University of Washington. The registered enrollment target is 36 participants, above the 28-participant average among 4 other Transtibial Amputation trials with a reported enrollment target (29% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02440711, a NA study of Transtibial Amputation, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to evaluate endurance, walking performance, mobility, and perceived exertion of transtibial prosthesis users (i.e., study participants) walking with a conventional energy storing prosthetic foot (ESF) and a novel modified running-specific prosthesis (mRSF). A randomized cross-over study will be conducted to determine if the mRSF provides superior performance to the ESF, which is commonly prescribed to most active individuals with lower limb amputation.
Primary Outcome
Breath-by-Breath VO2 was collected as participants walked on a treadmill at self selected fast, normal, and slow speeds. Participants walked for 6 minutes at each speed (and in each experimental condition). VO2 was normalized energy expenditure to each participant's biological mass (i.e., body mass without prosthesis) Normalized VO2 data were averaged to produce 30-s values for minutes 3-6 of each trial. These 30-s values were used in for the described analyses. Both gross and net VO2 were exami
Conditions Studied
Interventions
- DEVICE Energy storing foot (ESF)
- DEVICE Modified running specific foot (mRSF)
Study Locations (1)
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2015-05 |
| Est. Completion | 2018-03 |
| Phase | NA |
What the finished NCT02440711 record still lists
NCT02440711 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, above the 28-participant average among 4 other Transtibial Amputation trials with a reported enrollment target (29% higher).
The record links to 1 condition, with Transtibial Amputation appearing as the primary indexed condition, and to 2 interventions - of which Energy storing foot (ESF) is the first listed.
NCT02440711 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT02440711 about?
NCT02440711 is a clinical study titled "Evaluation of a Modified Running-specific Prosthetic Foot". The goal of this study is to evaluate endurance, walking performance, mobility, and perceived exertion of transtibial prosthesis users (i.e., study participants) walking with a conventional energy storing prosthetic foot (ESF) and a novel modified running-specific prosthesis (mRSF). A randomized cro...
What is the current status of trial NCT02440711?
This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2015-05. Estimated completion is 2018-03.
What conditions does trial NCT02440711 study?
This clinical trial studies the following conditions: Transtibial Amputation.
What interventions are being tested in trial NCT02440711?
The interventions under investigation include: Energy storing foot (ESF) (DEVICE), Modified running specific foot (mRSF) (DEVICE).
Who is sponsoring clinical trial NCT02440711?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02440711 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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