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

NCT00717691 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-04-30

No results posted yet for this study

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.

Conditions

  • Hallux Limitus

Interventions

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.

Sponsors & Collaborators

  • Dynasplint Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Stanley R Kalish, DPM, FACFAS · Atlanta Foot and Leg Clinic

  • Buck Willis, PhD · Dynasplint Systems, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-10-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00717691 on ClinicalTrials.gov