Ankle Equinus Contracture Treated With Dynamic Splinting

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01238484
• Other study ID #: 2010:004
• Status: Terminated
• Phase: N/A
• First received: November 9, 2010
• Last updated: July 10, 2013
• Start date: August 2010
• Est. completion date: January 2013

Study information

• Verified date: July 2013
• Source: Dynasplint Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Contracture
• Ankle Equinus
• Clubfoot
• Contracture
• Diabetes Mellitus
• Equinus Deformity

Intervention

Other:
• Standard of care
shoe modification home stretching exercises

Device:
• Dynasplint
shoe modification home stretching exercises Ankle Dorsiflexion Dynasplint

Locations

Country	Name	City	State
United States	Lopez Ankle and Foot	Fort Worth	Texas
United States	Atlanta Foot and Leg Clinic	Jonesboro	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Dynasplint Systems, Inc.	McMurry University

Country where clinical trial is conducted

United States, 

References & Publications (17)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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.

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. — View Citation

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

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. — View Citation

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. Epub 2006 Feb 13. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of Motion	The primary outcome is change in ankle range of motion	4 months	No
Secondary	Pain	The secondary outcome will be change in pain scale rating as reported by patient	4 months	No