NCT00717691

Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Dynasplint Systems, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to regain range of motion of the great toe with dynamic splinting which will help reduce great toe's pain and swelling.

Detailed description

Determine the efficacy of dynamic splinting in treating patients with hallux limitus, in a randomized, controlled trial.

Conditions

• Hallux Limitus

Interventions

Type	Name	Description
DEVICE	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.
OTHER	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.

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-10-01
• Completion: 2008-12-01
• First posted: 2008-07-17
• Last updated: 2012-04-30

Locations

2 sites across 1 country: United States