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

April 27, 2012 updated by: Dynasplint Systems, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Jonesboro, Georgia, United States, 30236
        • Atlanta Foot and Leg Clinic
      • Marietta, Georgia, United States, 30066
        • Ankle and Foot Centers, PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Immediate fitting with dynamic splinting following diagnosis of hallux limitus.
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.
No Intervention: 2
Control arm; patients only treated with standard of care following diagnosis of hallux limitus.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in passive Range of Motion, Extension
Time Frame: same
same

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dynasplint Systems, Inc.

Investigators

  • Principal Investigator: Stanley R Kalish, DPM, FACFAS, Atlanta Foot and Leg Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 15, 2008

First Submitted That Met QC Criteria

July 16, 2008

First Posted (Estimate)

July 17, 2008

Study Record Updates

Last Update Posted (Estimate)

April 30, 2012

Last Update Submitted That Met QC Criteria

April 27, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008.003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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