Passive Calf Stretching Therapy in Peripheral Artery Disease

Part of paid clinical trials in University Park, Pennsylvania.

Sponsor
Penn State University
Study ID
NCT06041880
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Passive calf muscle stretching device — DEVICE
    Modified night splints will be used to passive stretch the calf muscle.

Study Details

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.

Key Dates

Start date
Apr 1, 2024
Status verified
Jul 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: 4-weeks of passive calf stretching for 30 minutes 5 days a week
    A modified plantar fasciitis ankle splint will be used to passively stretch the calf muscle.
  • No Intervention: 4-weeks of no-stretching
    No device will be used to stretch the calf muscle. Participants will go about their normal daily activity for 4-weeks.

Primary Outcome Measure

6-minute walk test distance [ Time Frame: 6-12 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State UniversityUniversity ParkPennsylvania16802-

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