Ankle Equinus Contracture Treated With Dynamic Splinting

July 10, 2013 updated by: Dynasplint Systems, Inc.

Ankle Equinus Contracture Treated With Dynamic Splinting in a Randomized, Controlled Trial

The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in treating contracture for patients with Ankle Equinus secondary to diabetes mellitus.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

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
    • Texas
      • Fort Worth, Texas, United States, 76164
        • Lopez Ankle and Foot

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:

  • Previous Diagnosis Diabetes Mellitus
  • Reduced flexibility in AROM of extension in the ankle
  • Less than 10º Maximal, Active Dorsiflexion, while upright
  • Impaired gait pattern

Exclusion Criteria:

  • Previous surgical treatment for this pathology
  • Previous surgery of the Achilles tendon or triceps surae
  • Current treatment with corticosteroids
  • Current treatment with Botulinium Toxin-A (Botox), lower extremity
  • Current treatment Fluoroquinolones (antibiotic medication)
  • Current use of muscle relaxant medications
  • Fibromyalgia
  • Stroke, CVA, Brain Injury, Spinal Cord Injury, or any neural pathology causing plasticity or hypertonicity
  • Current participation in manual, physical therapy
  • Treatment with electrical stimulation assisting ambulation (i.e. Bioness, WalkAide, Parastep, etc.)
  • Preexisting open sores on foot or leg

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: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control
Patients in the control group will be treated with the current standard of care including shoe modification and home stretching exercises.
Other: Standard of care
shoe modification home stretching exercises
EXPERIMENTAL: Experimental
Patients assigned to the experimental group will receive the current standard of care as well as the Ankle Dorsiflexion Dynasplint.
Device: Dynasplint
shoe modification home stretching exercises Ankle Dorsiflexion Dynasplint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion
Time Frame: 4 months
The primary outcome is change in ankle range of motion
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 4 months
The secondary outcome will be change in pain scale rating as reported by patient
4 months

Collaborators and Investigators

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

Sponsor

Dynasplint Systems, Inc.

Collaborators

McMurry University

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

August 1, 2010

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

November 9, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (ESTIMATE)

November 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 10, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010:004

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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