Foot Pain Clinical Trial
Official title:
Orthofeet: A Prospective Proof of Concept Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Pain Relief Footwear
The purpose of this prospective proof of concept study is to examine the effectiveness of a new pain relief footwear (Orthofeet) on function and daily activities. he investigators hypothesize that Orthofeet will reduce foot pain leading to an increase in daily physical activities, measured objectives using validated wearables (PAMSys and Garmin wristwatch), and functional performance (gait and balance). In addition, the investigators hypothesis that reduction in foot pain is associated with reduced physiological stress response (HRV) and better community engagement (assessed by life space questionnaire).
A clinical study at the Baylor College of Medicine, to evaluate short and intermediate benefits and effectiveness of a novel pain relief footwear, called Orthofeet. This is a randomized crossed over trial. The duration of the study would be 12-week. The investigators will recruit 50 eligible ambulatory adults (age 50 years or older) with moderate to severe self-reported foot pain. Participants will be randomly assigned to Group A (25 subjects) and Group B (25 subjects). There is no difference in assessments or eligibility between Group A and Group B, the only difference is when they have the opportunity to try the shoes for 6 weeks. Group A will receive a pair of Orthofeet shoes with adjustable insoles and will be asked to wear it every day activities of daily living for duration of six weeks. Participants will be also encourage to wear the shoes inside of home if possible. Group B will be followed for duration of six weeks. At six weeks the groups will be switched and group B will receive and a pair of Orthofeet shoes with adjustable insoles and Group B will follow-up for six week without Orthofeet shoes. Participants will be assessed at baseline, week-1, week-6, week 7, and week 12. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04894396 -
Orthotics, Pain & Fear of Falling
|
N/A | |
| Not yet recruiting |
NCT01940289 -
Validation of Algometry for Use in the Human Foot
|
N/A |