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Ankle Equinus Contracture Treated With Dynamic Splinting

This study has been terminated.
(Centers could not meet enrollment goals)
Sponsor:
Collaborator:
McMurry University
Information provided by (Responsible Party):
Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01238484
First received: November 9, 2010
Last updated: July 10, 2013
Last verified: July 2013
  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:


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


Enrollment: 15
Study Start Date: August 2010
Study Completion Date: January 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Georgia
Atlanta Foot and Leg Clinic
Jonesboro, Georgia, United States, 30236
United States, Texas
Lopez Ankle and Foot
Fort Worth, Texas, United States, 76164
Sponsors and Collaborators
Dynasplint Systems, Inc.
McMurry University
  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.
Kalish SA, Willis FB. Hallux Limitus and Dynamic Splinting: a Retrospective Series. The Foot & Ankle Online Journal 2009 Apl;2(4),1

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: July 10, 2013
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
Congenital Abnormalities
Endocrine System Diseases
Foot Deformities
Foot Deformities, Acquired
Foot Deformities, Congenital
Glucose Metabolism Disorders
Joint Diseases
Limb Deformities, Congenital
Lower Extremity Deformities, Congenital
Metabolic Diseases
Muscular Diseases
Musculoskeletal Abnormalities
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 27, 2014