NCT06041880

Passive Calf Stretching Therapy in Peripheral Artery Disease

To Stretch, Not Strain: Impact of Passive Stretching on Calf Muscle and Gait Mechanics in PAD

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Penn State University · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the effects of passive calf muscle stretching in patients diagnosed with peripheral artery disease (PAD). The main question it aims to answer are: 1. To determine if daily calf muscle stretching at home improves calf muscle and vascular health. 2. To determine if daily calf muscle stretching at home improves walking performance. Participants will use inflatable ankle splints for 30 minutes a day, 5 days a week for 4-weeks on both days and 4-weeks of no stretching.

Detailed description

Patients with peripheral artery disease will passively stretch their calf muscles using a stretch device on both feet for 30 minutes a day for 4 weeks. Blood vessel health and size, length and function of the calf muscles and tendons and walking performance will be measured. Joint and foot movements as well as calf muscle oxygen levels will be measured during walking performance tests.

Conditions

• Peripheral Artery Disease
• Claudication, Intermittent

Interventions

Type	Name	Description
DEVICE	Passive calf muscle stretching device	Modified night splints will be used to passive stretch the calf muscle.

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2023-09-18
• Last updated: 2025-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study