Hallux Limitus
Conditions
Keywords
Hallux Limitus, Dynamic Splinting, Dynasplint
Brief 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.
Interventions
DEVICEMetatarsophalangeal 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.
OTHERStandard 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.
Sponsors
Dynasplint Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Reduced flexibility in AROM of extension in the great toe * Pain that is worsened by walking and/or squatting * Impaired gait pattern
Exclusion criteria
* Metatarsal stress fracture * Interdigital neuroma * Sesamoid pathology * Gout * Metatarsalgia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Active Range of Motion of Hallux (great toe) Extension | Two Months |
Secondary
| Measure | Time frame |
|---|---|
| Change in passive Range of Motion, Extension | same |
Countries
United States
Outcome results
None listed