Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Calf-stretching device versus night splints for plantar fasciitis

Official title: Novel Stretching Device Versus Night Splints a Prospective, Randomized Study in the Effectiveness of Treating Plantar Fasciitis

Run by SAE Orthopedics · NCT05216679 · Data updated 2026-11-12

This test compares a home calf-stretching device with night splints to see if one reduces heel pain in adults with plantar fasciitis.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorSAE Orthopedics
Industry-sponsored
Locations1 site (Carterville, Illinois)
StatusRecruiting
StartedApril 15, 2026
Main results expectedJuly 1, 2026
Study endsDecember 1, 2026
Registry record updatedApril 28, 2026
Trial IDNCT05216679 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 and older with a diagnosis of plantar fasciitis who can understand the study, safely use the assigned device after instruction, and attend visits at the Carterville, IL site are ideal candidates.

Probably not a fit

Patients with ankle fusion, significant balance impairment that prevents safe device use, recent corticosteroid injection within 60 days, pregnancy, or inability to attend the site visit are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

One hundred adults previously diagnosed with plantar fasciitis will complete baseline questionnaires and have calf (triceps surae) flexibility measured using the AcuFlex device. Participants will be randomly assigned by a random number generator to use either a fitted night splint or the AcuFlex stretching unit at home for six weeks, with a 3-week check-in call. Flexibility measurements are captured during a five-minute standing assessment with distance sensors, and symptom questionnaires are repeated after six weeks. The questionnaire responses will be analyzed to compare symptom change between the two home therapies.

Why it matters

Potential benefit: If successful, the AcuFlex device could provide a convenient home-based stretching option that reduces plantar fasciitis pain and improves function comparable to or better than night splints.

How similar studies have gone: Previous trials have shown benefit from stretching exercises and night splints for plantar fasciitis, but the AcuFlex device itself has not been widely tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* age 18 years and older
* diagnosis of plantar fasciitis
* ability to understand the purpose of the study
* ability to safely use the device they are assigned after education and return demonstration.

Exclusion Criteria:

* patients with ankle fusion
* significant balance impairment which would prohibit safe use of the AcuFlex device
* corticosteroid injection within last 60 days
* pregnancy

Where it's running

  • SAE Orthopedics
    Carterville, Illinois, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.