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NCT04337554 · ClinicalTrials.gov registry record
Exoskeleton Footwear to Improve Walking
A clinical trial, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- 47
- Enrollment target
NCT04337554: Completed study, sponsored by VA Office of Research and Development.
NCT04337554 is a clinical trial that has completed, run by VA Office of Research and Development. The registered enrollment target is 47 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04337554 has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- 47 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the best assistance level of an exoskeleton footwear (EF) that can assist walking for people older than 40 with and without peripheral artery disease (PAD). The test will be performed on two different groups of people for this study that include: 1) people with PAD, and 2) individuals who don't have PAD. Data will be collected from 50 healthy older individuals and 25 patients with PAD, both groups will be 40 years or older. Gait biomechanics, muscle oxygenation, and energy cost for seven different walking conditions including normal walking, walking with EF with no assistance, and walking with EF with 5 different levels of assistance will be collected from the healthy older individuals. Additionally, subject-reported outcomes after each walking conditions including perceived comfort and fatigue, rate of perceived exertion and feasibility of the EF will be collected. Gait biomechanics, muscle oxygenation, energy cost, and patient-reported outcomes will be measured in patients with PAD for four walking conditions including normal walking, walking with EF but no assistance, walking with EF with the best two assistance levels. Subjects will be allowed to acclimate to the EF prior to recording data. All patients with PAD will participate in feasibility interviews that will assess acceptability, demand, implementation, and practicality. All subjects will be asked to fill out questionnaires that assess quality of life, physical function, and the ability to complete activities of daily living.
Primary Outcome
The primary outcome variables of biological contribution to ankle torque and power will be calculated from five steps per leg during the flat ground walking. Ground reaction forces for the vertical, anterior-posterior, and medial-lateral direction, and joint angles, joint angular velocity for the hip, knee, and ankle during the stance phase of walking, joint torques and powers are will also be calculated.
Interventions
- DEVICE Exoskeleton footwear
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2020-08-01 |
| Est. Completion | 2025-09-30 |
What the finished NCT04337554 record still lists
NCT04337554 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 47 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Exoskeleton footwear is the first listed.
NCT04337554 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04337554 about?
NCT04337554 is a clinical study titled "Exoskeleton Footwear to Improve Walking". The purpose of this study is to determine the best assistance level of an exoskeleton footwear (EF) that can assist walking for people older than 40 with and without peripheral artery disease (PAD). The test will be performed on two different groups of people for this study that include: 1) people w...
What is the current status of trial NCT04337554?
This trial is currently completed. The enrollment target is 47 participants. The study started on 2020-08-01. Estimated completion is 2025-09-30.
What interventions are being tested in trial NCT04337554?
The interventions under investigation include: Exoskeleton footwear (DEVICE).
Who is sponsoring clinical trial NCT04337554?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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