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

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

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

Conditions
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Hallux Limitus

Intervention / Treatment
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* Device: Metatarsophalangeal Extension Dynasplint System
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Immediate fitting with dynamic splinting following diagnosis of hallux limitus. | Device: Metatarsophalangeal Extension Dynasplint System<br>* 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.<br>Other: Standard of Care<br>* 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.<br>|
| No Intervention: 2<br>Control arm; patients only treated with standard of care following diagnosis of hallux limitus. | Other: Standard of Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Active Range of Motion of Hallux (great toe) Extension |  | Two Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in passive Range of Motion, Extension |  | same | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hallux Limitus, Dynamic Splinting, Dynasplint