Clinical trial NCT01238484: Ankle Equinus Contracture Treated With Dynamic Splinting
Official title: Ankle Equinus Contracture Treated With Dynamic Splinting in a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ankle Equinus
Ankle Contracture
Diabetes Mellitus
Keywords: Ankle Equinus
Ankle contracture
Diabetes Mellitus
Dynasplint
AFD
Lead sponsor: Dynasplint Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: McMurry University
First posted: 2010-11-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Range of Motion
timeFrame: 4 months
Secondary outcomes:
measure: Pain
timeFrame: 4 months
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Atlanta Foot and Leg Clinic
state: Georgia
city: Fort Worth
country: United States
facility: Lopez Ankle and Foot
state: Texas
Study officials:
References:
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citation: 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.
citation: 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.
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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. doi: 10.1177/0363546505284186. Epub 2006 Feb 13.
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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. doi: 10.7547/1000161.
citation: Kalish SA, Willis FB. Hallux Limitus and Dynamic Splinting: a Retrospective Series. The Foot & Ankle Online Journal 2009 Apl;2(4),1
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