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NCT03805464 · ClinicalTrials.gov registry record · NA
Walking Gait Biomechanics Following Knee Joint Effusion
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT03805464 is a NA study that has completed, run by Duke University. The registered enrollment target is 14 participants.
The verdict
NCT03805464, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the sensitivity of a wearable sensor to detect changes in knee joint loading using an experimental knee joint effusion as a model for a common clinical physiological alteration in joint status. The rationale for this project is that it will establish the efficacy of an inexpensive, clinically, and publicly available device that can detect changes in biomechanical loading due to acute physiologic change in joint status. The study will utilize a cross-sectional cohort study design and will seek to enroll 25 male and female healthy adult participants (18-35 yo). Participants will report to the laboratory for three total sessions (Session 1: informed consent and task familiarization; Session 2: testing; Session 3: knee joint status assessment). The primary outcomes of interest include lower extremity thigh and shank acceleration and velocity data (wearable sensor data), lower extermity 3D kinematics and kinetics (motion capture data), and lower extremity muscle function (EMG data) during walking gait, as well as functional balance and patient-reported subjective outcomes. Data will be analyzed by calculating change scores from the pre- to post-experimental effusion outcome measure testing. Paired-samples t-tests and Cohen's d effect sizes will be used to assess changed in wearable sensor data from pre- to post-experimental effusion. Correlation statistics will be used to determine if there are association between the motion capture and wearable sensor data. The potential risks associated with an experimental joint effusion will be addressed by maintaining appropriate sterile conditions and having the participant check-in with the PI (licensed healthcare provider) at 48 hours following testing session.
Interventions
- OTHER Knee Joint Effusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-01-29 |
| Est. Completion | 2023-05-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03805464
The ClinicalTrials.gov registry entry for NCT03805464 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Knee Joint Effusion is the first listed.
NCT03805464 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03805464 about?
NCT03805464 is a clinical study titled "Walking Gait Biomechanics Following Knee Joint Effusion". The purpose of this study is to determine the sensitivity of a wearable sensor to detect changes in knee joint loading using an experimental knee joint effusion as a model for a common clinical physiological alteration in joint status. The rationale for this project is that it will establish the eff...
What is the current status of trial NCT03805464?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2019-01-29. Estimated completion is 2023-05-18.
What interventions are being tested in trial NCT03805464?
The interventions under investigation include: Knee Joint Effusion (OTHER).
Who is sponsoring clinical trial NCT03805464?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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