Novel Stretching Device Versus Night Splints
ConditionPlantar Fasciitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSAE Orthopedics
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
patients with ankle fusion
significant balance impairment which would prohibit safe use of the AcuFlex device
corticosteroid injection within last 60 days
pregnancy
Trial design
Design model
Single group
Treatments tested in this trial
Night splints
DeviceA 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)
DeviceThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Main studyExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
6 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov