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NCT03532100 · ClinicalTrials.gov registry record · NA
Pivot-Flex Foot: Optimal Coupling Ratio Between Transverse and Sagittal-plane Motions Using a Torsionally Adaptive Prosthesis for Individuals With Lower Limb Amputation
A NA study of Lower Extremity Amputation, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT03532100: Completed NA study of Lower Extremity Amputation, sponsored by VA Office of Research and Development.
NCT03532100 is a NA study of Lower Extremity Amputation that has completed, run by VA Office of Research and Development. The registered enrollment target is 14 participants, below the 18-participant average among 3 other Lower Extremity Amputation trials with a reported enrollment target (22% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03532100, a NA study of Lower Extremity Amputation, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
When prescribing a prosthetic foot, clinicians face a dizzying array of choices as more than 200 different prosthetic feet are available. While these conventional prosthetic feet primarily function in the sagittal plane, the intact foot and ankle comprise a complex set of joints that allow rotation in multiple planes of motion. Some of these motions are coupled, meaning rotation in one plane induces motion in another. One such coupling is between the sagittal and transverse planes. For every step, plantar- and dorsi-flexion motion in the sagittal plane is coupled with external and internal rotation of the shank relative to the foot in the transverse plane. There is no prosthetic foot available for prescription that mimics this natural coupling. To investigate the need for this coupling, the investigators have built a torsionally adaptive prosthesis where the coupling ratio between the transverse- and sagittal-planes can be independently controlled with a motor. This research has one specific aim: to identify the optimal coupling ratio between transverse- and sagittal-plane motions using a novel, torsionally adaptive prosthesis for individuals with lower limb amputation. The investigators will conduct a human subject experiment wearing the motor-driven and computer controlled torsionally adaptive prosthesis. Individuals with lower limb amputation will be asked to walk in a straight line and in both directions around a circle while the coupling ratio between transverse- and sagittal-plane motions is varied between trials. Participants will be blinded to the coupling ratio. The investigators hypothesize that: (1) a coupling ratio exists that minimizes undesirable transverse-plane socket torque and (2) there will be a coupling ratio that individuals with lower limb amputation prefer.
Primary Outcome
Peak transverse-plane prosthetic socket torque measured while walking normalized to body mass
Conditions Studied
Interventions
- DEVICE Torsionally adaptive prosthesis with 0:1 coupling ratio
- DEVICE Torsionally adaptive prosthesis with 1:6 coupling ratio
- DEVICE Torsionally adaptive prosthesis with 1:4 coupling ratio
- DEVICE Torsionally adaptive prosthesis with 1:3 coupling ratio
- DEVICE Torsionally adaptive prosthesis with 1:2 coupling ratio
Study Locations (1)
Washington
- VA Puget Sound Health Care System Seattle Division, Seattle, WA - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-04-18 |
| Est. Completion | 2024-11-18 |
| Phase | NA |
What the finished NCT03532100 record still lists
NCT03532100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 18-participant average among 3 other Lower Extremity Amputation trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Lower Extremity Amputation appearing as the primary indexed condition, and to 5 interventions - of which Torsionally adaptive prosthesis with 0:1 coupling ratio is the first listed.
NCT03532100 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT03532100 about?
NCT03532100 is a clinical study titled "Pivot-Flex Foot: Optimal Coupling Ratio Between Transverse and Sagittal-plane Motions Using a Torsionally Adaptive Prosthesis for Individuals With Lower Limb Amputation". When prescribing a prosthetic foot, clinicians face a dizzying array of choices as more than 200 different prosthetic feet are available. While these conventional prosthetic feet primarily function in the sagittal plane, the intact foot and ankle comprise a complex set of joints that allow rotation ...
What is the current status of trial NCT03532100?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2018-04-18. Estimated completion is 2024-11-18.
What conditions does trial NCT03532100 study?
This clinical trial studies the following conditions: Lower Extremity Amputation.
What interventions are being tested in trial NCT03532100?
The interventions under investigation include: Torsionally adaptive prosthesis with 0:1 coupling ratio (DEVICE), Torsionally adaptive prosthesis with 1:6 coupling ratio (DEVICE), Torsionally adaptive prosthesis with 1:4 coupling ratio (DEVICE), Torsionally adaptive prosthesis with 1:3 coupling ratio (DEVICE), Torsionally adaptive prosthesis with 1:2 coupling ratio (DEVICE).
Who is sponsoring clinical trial NCT03532100?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03532100 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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