Ankle Equinus Contracture Treated With Dynamic Splinting

NCT01238484 | Terminated

• 1 other identifier: 2010:004
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Ankle Equinus; Ankle Contracture; Diabetes Mellitus

Keywords

Ankle Equinus; Ankle contracture; Diabetes Mellitus; Dynasplint; AFD

Outcome Measures

Primary Outcomes (1)

• Range of Motion

  The primary outcome is change in ankle range of motion

  4 months

Secondary Outcomes (1)

• Pain

  4 months

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Experimental

EXPERIMENTAL

Patients assigned to the experimental group will receive the current standard of care as well as the Ankle Dorsiflexion Dynasplint.

Device: Dynasplint

Interventions

Standard of care OTHER

shoe modification home stretching exercises

Control

Dynasplint DEVICE

shoe modification home stretching exercises Ankle Dorsiflexion Dynasplint

Experimental

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dynasplint Systems, Inc.: lead
• McMurry University: collaborator

Study Sites (2)

Atlanta Foot and Leg Clinic

Jonesboro, Georgia, 30236, United States

Location

Lopez Ankle and Foot

Fort Worth, Texas, 76164, United States

Location

Related Publications (17)

• Van Gils CC, Roeder B. The effect of ankle equinus upon the diabetic foot. Clin Podiatr Med Surg. 2002 Jul;19(3):391-409, vi. doi: 10.1016/s0891-8422(02)00010-1.

  PMID: 12379973 BACKGROUND

• Lavery LA, Armstrong DG, Boulton AJ; Diabetex Research Group. Ankle equinus deformity and its relationship to high plantar pressure in a large population with diabetes mellitus. J Am Podiatr Med Assoc. 2002 Oct;92(9):479-82. doi: 10.7547/87507315-92-9-479.

  PMID: 12381796 BACKGROUND

• Armstrong DG, Boulton AJ. Continuous Internet-based activity monitoring provides a surrogate marker for nocturnal polyuria in persons with diabetes mellitus at high risk for foot ulceration. Diabet Med. 2002 Dec;19(12):1034-5. doi: 10.1046/j.1464-5491.2002.00696_2.x. No abstract available.

  PMID: 12647847 BACKGROUND

• Dananberg HJ, Shearstone J, Guillano M. Manipulation method for the treatment of ankle equinus. J Am Podiatr Med Assoc. 2000 Sep;90(8):385-9. doi: 10.7547/87507315-90-8-385.

  PMID: 11021048 BACKGROUND

• Lopez AA, Kalish SR, John MM, Willis FB. Reduction of Ankle Equinus Contracture Secondary to Diabetes Mellitus with Dynamic Splinting. Foot & Ankle Online Journal. 2010 3(3):13-18

  BACKGROUND

• Birke JA, Patout CA Jr, Foto JG. Factors associated with ulceration and amputation in the neuropathic foot. J Orthop Sports Phys Ther. 2000 Feb;30(2):91-7. doi: 10.2519/jospt.2000.30.2.91.

  PMID: 10693087 BACKGROUND

• Wallny T, Brackmann H, Kraft C, Nicolay C, Pennekamp P. Achilles tendon lengthening for ankle equinus deformity in hemophiliacs: 23 patients followed for 1-24 years. Acta Orthop. 2006 Feb;77(1):164-8. doi: 10.1080/17453670610045867.

  PMID: 16534718 BACKGROUND

• Grady JF, Saxena A. Effects of stretching the gastrocnemius muscle. J Foot Surg. 1991 Sep-Oct;30(5):465-9.

  PMID: 1783755 BACKGROUND

• Bowers AL, Castro MD. The mechanics behind the image: foot and ankle pathology associated with gastrocnemius contracture. Semin Musculoskelet Radiol. 2007 Mar;11(1):83-90. doi: 10.1055/s-2007-984418.

  PMID: 17665354 BACKGROUND

• Mullaney MJ, McHugh MP, Tyler TF, Nicholas SJ, Lee SJ. Weakness in end-range plantar flexion after Achilles tendon repair. Am J Sports Med. 2006 Jul;34(7):1120-5. doi: 10.1177/0363546505284186. Epub 2006 Feb 13.

  PMID: 16476917 BACKGROUND

• Chen L, Greisberg J. Achilles lengthening procedures. Foot Ankle Clin. 2009 Dec;14(4):627-37. doi: 10.1016/j.fcl.2009.08.002.

  PMID: 19857837 BACKGROUND

• 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.

  BACKGROUND

• Lundequam P, Willis FB. Dynamic splinting home therapy for toe walking: a case report. Cases J. 2009 Nov 10;2:188. doi: 10.1186/1757-1626-2-188.

  PMID: 19946498 BACKGROUND

• Sheridan L, Lopez A, Perez A, John MM, Willis FB, Shanmugam R. Plantar fasciopathy treated with dynamic splinting: a randomized controlled trial. J Am Podiatr Med Assoc. 2010 May-Jun;100(3):161-5. doi: 10.7547/1000161.

  PMID: 20479445 BACKGROUND

• Kalish SA, Willis FB. Hallux Limitus and Dynamic Splinting: a Retrospective Series. The Foot & Ankle Online Journal 2009 Apl;2(4),1

  BACKGROUND

• Huang ES, Basu A, O'Grady M, Capretta JC. Projecting the future diabetes population size and related costs for the U.S. Diabetes Care. 2009 Dec;32(12):2225-9. doi: 10.2337/dc09-0459.

  PMID: 19940225 BACKGROUND

• Kooistra B, Dijkman B, Einhorn TA, Bhandari M. How to design a good case series. J Bone Joint Surg Am. 2009 May;91 Suppl 3:21-6. doi: 10.2106/JBJS.H.01573.

  PMID: 19411496 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 10, 2010
• Study Start: August 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 11, 2013

Record last verified: 2013-07

Locations

US (2)