Novel Stretching Device Versus Night Splints

Part of paid clinical trials in Carterville, Illinois.

Sponsor
SAE Orthopedics
Study ID
NCT05216679
Status
Recruiting
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Conditions

  • Plantar Fasciitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Night splints — DEVICE
    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.
  • Triceps Surae Stretching and Flexibility Assessment Device (TESS) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Apr 15, 2026
Status verified
Apr 2026
Primary completion
Jul 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Main study
    This is the only arm of the study. It is a 6 week period where the participants will either be using night splints or the AcuFlex device to treat their plantar fasciitis symptoms.

Primary Outcome Measure

Number of participants who will attend follow up appointment and describe their symptoms and pain using a standard 0-10 pain chart. [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
SAE OrthopedicsCartervilleIllinois62918
Mike Davis, MD
[email protected]
6185253505
Corey Hopkins, BS
[email protected]
6183352804
Aren Abell, BS (SUB_INVESTIGATOR)
Billy Braid, BS (SUB_INVESTIGATOR)

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