RecruitingNot ApplicableNCT05216679

Novel Stretching Device Versus Night Splints

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


Sponsor

SAE Orthopedics

Enrollment

100 participants

Start Date

Apr 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

A set of 100 patients previously diagnosed with plantar fasciitis will be given initial questionnaires about their symptoms and randomly assigned either night splints or the novel calf stretching device. The participants will use each device for 6 weeks. At the end of those 6 weeks, they will return for a follow up questionnaire. The answers in the questionnaire will be analyzed to compare the effectiveness of night splints to calf stretching.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

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

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Interventions

DEVICENight splints

A night splint is a brace the patient wears on their foot to keep it in a dorsiflexed position while they sleep. It is the first line treatment for plantar fasciitis.

DEVICETriceps Surae Stretching and Flexibility Assessment Device (TESS)

The AcuFlex device is a slant board with a bar added for balance that the participant will stand on in 5 minute intervals throughout the day to stretch their calves, and potentially treat their plantar fasciitis symptoms. Measurements will be taken and recorded by sensors beneath the participants heels.


Locations(1)

SAE Orthopedics

Carterville, Illinois, United States

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NCT05216679


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