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Novel Stretching Device Versus Night Splints

NCT05216679 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-28

No results posted yet for this study

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

Interventions

DEVICE

Night 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.

DEVICE

Triceps 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.

Sponsors & Collaborators

  • SAE Orthopedics

    lead INDUSTRY

Principal Investigators

  • Mike Davis, MD · SAE Orthopedics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2026-07-01
Completion
2026-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05216679 on ClinicalTrials.gov