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NCT05520008 · ClinicalTrials.gov registry record · NA
Game-Based Foot & Ankle Exercise for Those With Lower Extremity Edema
A NA study of Venous Insufficiency of Leg and Lower Extremity Swelling, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT05520008: Completed NA study of Venous Insufficiency of Leg and Lower Extremity Swelling, sponsored by Baylor College of Medicine.
NCT05520008 is a NA study of Venous Insufficiency of Leg and Lower Extremity Swelling that has completed, run by Baylor College of Medicine. The registered enrollment target is 19 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
NCT05520008, a NA study of Venous Insufficiency of Leg and Lower Extremity Swelling, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
The present study aims to use a game-based tele-exercise program for patients using a compression garment to improve lower extremity edema. This tele-exercise gaming platform can work as an efficient exercise to improve patients' muscle strength. It also can be helpful in improving edema and venous return and can be used in addition to compression garments to increase efficacy. The sample size (n=30) is convenient and designed to explore acceptability and feasibility. Eligible participants will be screened at the Baylor college of Medicine Clinic based on the inclusion/exclusion criteria. Participants who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. Both groups will receive a compression garment to use for 4 weeks, and in the intervention group, patients will receive a sensor and a tablet to play foot \& ankle exercise games twice a day for 5 minutes. Study participation will be 4 weeks for all participants. Participants will be assessed in two visits: a baseline visit (BL) and a visit at the end of the 4 weeks (W4). The primary outcomes will be calf circumference, foot volume, and pitting edema grade. Secondary outcomes include limb strength, foot perfusion, gait assessment (gait speed, stride length, double stance, and gait steadiness), balance, and quality of life. The coordinator will monitor patients weekly to see their adherence to the compression garment and game-based exercise.
Primary Outcome
Calf circumference will be assessed with a soft measuring tape for each leg
Conditions Studied
Interventions
- OTHER Game-based exercise
Study Locations (1)
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2022-11-03 |
| Est. Completion | 2023-10-06 |
| Phase | NA |
What the finished NCT05520008 record still lists
NCT05520008 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 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 3 conditions, with Venous Insufficiency of Leg appearing as the primary indexed condition, and to 1 intervention - of which Game-based exercise is the first listed.
NCT05520008 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05520008 about?
NCT05520008 is a clinical study titled "Game-Based Foot & Ankle Exercise for Those With Lower Extremity Edema". The present study aims to use a game-based tele-exercise program for patients using a compression garment to improve lower extremity edema. This tele-exercise gaming platform can work as an efficient exercise to improve patients' muscle strength. It also can be helpful in improving edema and venous ...
What is the current status of trial NCT05520008?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2022-11-03. Estimated completion is 2023-10-06.
What conditions does trial NCT05520008 study?
This clinical trial studies the following conditions: Venous Insufficiency of Leg, Lower Extremity Swelling, Lower Extremity Edema.
What interventions are being tested in trial NCT05520008?
The interventions under investigation include: Game-based exercise (OTHER).
Who is sponsoring clinical trial NCT05520008?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05520008 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05520008's enrollment target sits among peer trials
19 1861st of 2000 higher than 138 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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