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NCT04222751 · ClinicalTrials.gov registry record · NA
Static Muscular Stretching for Treatment of PAD
A NA study, sponsored by Florida State University.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT04222751: Completed NA study, sponsored by Florida State University.
NCT04222751 is a NA study that has completed, run by Florida State University. 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). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04222751, a NA study, has completed, sponsored by Florida State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
Patients with peripheral arterial disease (PAD) often have walking impairment due to insufficient oxygen supply to skeletal muscle. The investigator's pilot study in PAD patients has shown that endothelial function and walking distance improve with regular static muscle stretching. Therefore, the purpose of this study is to determine whether prescriptive muscle stretching improves muscle oxygenation and walking ability in PAD patients. This is a single-blinded study in 40 patients with stable symptomatic PAD. Patients assigned to the stretch group will use ankle splints (both legs) to perform static muscle stretching for 4 weeks (ankle dorsiflexion applied 30 min/d, 5 days/wk). Patients assigned to the control group will also wear the ankle splints daily but without invoking any dorsiflexion, i.e., without stretching. Measurements will consist of ankle-brachial index (ABI) at rest and post-exercise, skeletal muscle oxygenation (evaluated with near-infrared spectroscopy (NIRS)), and 6 minute walk test (6MWT), performed at baseline and after 4 weeks of stretching (or control splint placement). In addition, NIRS will be used to evaluate muscle oxygenation while patients are wearing the splint device in order to quantitatively prescribe the angle of dorsiflexion that provides optimum stretch and deoxygenation of the calf muscles without causing pain. Primary outcomes include increased muscle oxygenation during exercise and walking distance after 4 weeks of static muscle stretching. Results from this study will be used to support funding applications for a larger efficacy trial.
Primary Outcome
Noninvasive assessment via NIRS monitor
Interventions
- DEVICE Ankle Splint
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-07-29 |
| Est. Completion | 2025-06-01 |
| Phase | NA |
What the finished NCT04222751 record still lists
NCT04222751 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 0 conditions, and to 1 intervention - of which Ankle Splint is the first listed.
NCT04222751 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04222751 about?
NCT04222751 is a clinical study titled "Static Muscular Stretching for Treatment of PAD". Patients with peripheral arterial disease (PAD) often have walking impairment due to insufficient oxygen supply to skeletal muscle. The investigator's pilot study in PAD patients has shown that endothelial function and walking distance improve with regular static muscle stretching. Therefore, the pu...
What is the current status of trial NCT04222751?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2020-07-29. Estimated completion is 2025-06-01.
What interventions are being tested in trial NCT04222751?
The interventions under investigation include: Ankle Splint (DEVICE).
Who is sponsoring clinical trial NCT04222751?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04222751's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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