50
Participants
Start Date
July 31, 2008
Primary Completion Date
October 31, 2008
Study Completion Date
December 31, 2008
Metatarsophalangeal Extension Dynasplint System
Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn for 30 minutes, three times per day, (while seated or resting in bed) totaling 1.5 hours per day.
Standard of Care
The current standard of care in treating Hallux Limitus will be given to all patients regardless of randomized categorization, and this includes: analgesic and nonsteroidal anti-inflammatory drugs (NSAIDs), orthotics with medial stiffness, and reduction of great toe movement in motions such as kneeling or squatting with the toes in an extended position.
Ankle and Foot Centers, PC, Marietta
Atlanta Foot and Leg Clinic, Jonesboro
Lead Sponsor
Dynasplint Systems, Inc.
INDUSTRY