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NCT05287646 · ClinicalTrials.gov registry record · NA
Quantifying Bone and Skin Movement in the Residual Limb of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray
A NA study of Amputation, Lower Limb, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT05287646: Recruiting NA study of Amputation, Lower Limb, sponsored by VA Office of Research and Development.
NCT05287646 is a NA study of Amputation, Lower Limb that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05287646, a NA study of Amputation, Lower Limb, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Individuals with lower extremity amputation are often challenged by complications that arise from poor prosthetic fit, including movement of the residual limb in the socket, known as pistoning. Pistoning can lead to gait instability, skin problems, and pain. Different prosthetic suspension systems have been developed to decrease this motion, including elevated vacuum suspension, which utilizes a pump to draw air from the socket. However, scientific analyses to understand the movement between the limb and socket have yet to be performed with a high level of accuracy. This study will use a state-of-the art imaging technique, known as dynamic stereo x-ray, to quantify the 3D movement of the residual limb in the socket. It is hypothesized that dynamic stereo x-ray will be a sensitive method to measure differences in residual limb movement between 2 different socket suspension techniques: suction and elevated vacuum suspension. This information is critical for advancing prosthetic treatments to reduce secondary conditions and degenerative changes that result from poor prosthetic fit.
Primary Outcome
To evaluate the 6 degree of freedom kinematics of the residual limb within the socket, participants with transtibial amputation will walk on a treadmill at a self-selected speed, at a speed 10% faster than their self-selected speed, and also perform a step-down task from an 18 cm high platform. These movement tasks will be completed under 2 conditions: with the elevated suspension active and with the elevated system inactive (traditional suction). Up to 4 trials of dynamic stereo x-ray will be c
Conditions Studied
Interventions
- DEVICE Suction Suspension First
- DEVICE Elevated Vacuum Suspension First
Study Locations (1)
New York
- VA NY Harbor Healthcare System, New York, NY - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2024-01-05 |
| Est. Completion | 2027-03-31 |
| Phase | NA |
What NCT05287646 shows while recruiting
NCT05287646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Amputation, Lower Limb appearing as the primary indexed condition, and to 2 interventions - of which Suction Suspension First is the first listed.
NCT05287646 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05287646 about?
NCT05287646 is a clinical study titled "Quantifying Bone and Skin Movement in the Residual Limb of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray". Individuals with lower extremity amputation are often challenged by complications that arise from poor prosthetic fit, including movement of the residual limb in the socket, known as pistoning. Pistoning can lead to gait instability, skin problems, and pain. Different prosthetic suspension systems h...
What is the current status of trial NCT05287646?
This trial is currently recruiting. It is a NA study. The enrollment target is 21 participants. The study started on 2024-01-05. Estimated completion is 2027-03-31.
What conditions does trial NCT05287646 study?
This clinical trial studies the following conditions: Amputation, Lower Limb.
What interventions are being tested in trial NCT05287646?
The interventions under investigation include: Suction Suspension First (DEVICE), Elevated Vacuum Suspension First (DEVICE).
Who is sponsoring clinical trial NCT05287646?
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 NCT05287646 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05287646's enrollment target sits among peer trials
21 1763rd of 2000 higher than 233 of 2,000 other NA trials
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