Novel Stretching Device Versus Night Splints

NCT05216679 | Recruiting DMC FDA Device

• 1 other identifier: AcuFlex
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plantar Fasciitis

Outcome Measures

Primary Outcomes (1)

• Number of participants who will attend follow up appointment and describe their symptoms and pain using a standard 0-10 pain chart.

  The participant will return their device and fill out a questionnaire (the same as the original questionnaire from the first visit) that will ask them to describe their symptoms and pain levels using a standard 0-10 pain scale chart. The investigators will then use a Mixed ANCOVA statistical test to compare the effectiveness of the AcuFlex device to night splints in symptom relief.

  6 weeks

Study Arms (1)

Main study

EXPERIMENTAL

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.

Device: Night splints; Device: Triceps Surae Stretching and Flexibility Assessment Device (TESS)

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.

Main study

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.

Main study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• SAE Orthopedics: lead

Study Sites (1)

SAE Orthopedics

Carterville, Illinois, 62918, United States

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Mike Davis, MD

  SAE Orthopedics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mike Davis, MD

CONTACT

618-525-3505; mdavis1060@gmail.com

Corey Hopkins, BS

CONTACT

618-335-2804; chopkin24@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 31, 2022
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available 6 months after study publication. Data will remain available indefinitely.
• Access Criteria: Dr. Davis will review requests to access study data on a case by case basis. All deidentified data from this study has potential to be shared with other researchers. Requests can be made via email to james.m.davis1@siu.edu.

Locations

US (1)