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Ankle Equinus Contracture Treated With Dynamic Splinting

This study is currently recruiting participants.
Verified May 2012 by Dynasplint Systems, Inc.
Sponsor:
Collaborator:
McMurry University
Information provided by (Responsible Party):
Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01238484
First received: November 9, 2010
Last updated: May 24, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Ankle Equinus
Ankle Contracture
Diabetes Mellitus
 Other: Standard of care
Device: Dynasplint

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ankle Equinus Contracture Treated With Dynamic Splinting in a Randomized, Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Dynasplint Systems, Inc.:

Primary Outcome Measures:
  • Range of Motion [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    The primary outcome is change in ankle range of motion


Secondary Outcome Measures:
  • Pain [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    The secondary outcome will be change in pain scale rating as reported by patient


Estimated Enrollment: 50
Study Start Date: August 2010
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238484

Contacts
Contact: Angel Lopez, DPM 817-625-1103
Contact: Lisa Lopez-Rolston 817-625-1103

Locations
United States, Georgia
Atlanta Foot and Leg Clinic Recruiting
Jonesboro, Georgia, United States, 30236
Contact: Stanley R Kalish, DPM, FACFAS     770-477-9535     SRKalish@bellsouth.net    
Principal Investigator: Stanley R Kalish, DPM, FACFAS            
United States, Texas
Lopez Ankle and Foot Recruiting
Fort Worth, Texas, United States, 76164
Contact: Angel Lopez, DPM            
Contact: Lisa Lopez-Rolston     817-625-1103        
Principal Investigator: Angel Lopez, DPM            
Sponsors and Collaborators
Dynasplint Systems, Inc.
McMurry University
Investigators
Study Director: Buck Willis, PhD Dynasplint Systems, Inc.
  More Information

Publications:
Lai J, Jones M, Willis B. Effect of Dynamic Splinting on Excessive Plantar Flexion Tone/Contracture: A Controlled, Cross-Over study. Proceedings of the 16th European Congress of Physical and Rehabilitation Medicine. Minerva Medica pubs, Italy, August 2008, pg 106-109.

Responsible Party: Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier: NCT01238484     History of Changes
Other Study ID Numbers: 2010:004
Study First Received: November 9, 2010
Last Updated: May 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dynasplint Systems, Inc.:
Ankle Equinus
Ankle contracture
Diabetes Mellitus
Dynasplint
AFD

Additional relevant MeSH terms:
Clubfoot
Equinus Deformity
Contracture
Diabetes Mellitus
Foot Deformities, Congenital
Foot Deformities
Musculoskeletal Diseases
 Foot Deformities, Acquired
Joint Diseases
Muscular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013