AcuFlex
Clinical Trial
Clinical Trial
Background
Plantar fasciitis, a painful inflammation of the soft tissue at the bottom of the foot near the heel, is estimated to affect 10% of the population. Muscular stretching is widely agreed upon to be helpful in the treatment of plantar fasciitis (Monteagudo et al, 2018).
AcuFlex™ is a lower extremity stretching and flexibility assessment device. The AcuFlex™ device is an adjustable slant board with a safety handle to allow its use with participants in an optimal position with back supported against a vertical surface, such as a wall. Onboard electronics will store measurements that assess progress and compliance.
Clinical Trial
STUDY RATIONALE
The ideal technique, duration, and frequency of stretching is less well understood by the scientific community than the fact that it is simply helpful. There is also a need to objectively measure the results of various muscle flexibility techniques. The outcomes that will be collected include changes in subjective questionnaire Visual Analog Scale (VAS), a physical activity questionnaire (IPAQ), and calf flexibility using non-invasive measurements. Additionally, this study will support and facilitate research among other orthopedic physicians and rehab professionals for improved treatment selection and patient outcomes.
Clinical Trial
STUDY OBJECTIVES
The primary objective of this study is to compare symptomatic relief of Plantar Fasciitis symptoms and improvement in flexibility of the triceps surae muscle unit using two different home treatment methods. A compare group for AcuFlex™ will be the well-researched method of home treatment for plantar fasciitis, the wearing of traditional night splints.
A secondary objective will be to obtain a baseline analysis of each patient’s calf flexibility using the AcuFlex™ device and then to reevaluate their flexibility at the completion of the study.