Ankle Equinus Contracture Treated With Dynamic Splinting
Primary Purpose
Ankle Equinus, Ankle Contracture, Diabetes Mellitus
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of care
Dynasplint
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Equinus focused on measuring Ankle Equinus, Ankle contracture, Diabetes Mellitus, Dynasplint, AFD
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
Sites / Locations
- Atlanta Foot and Leg Clinic
- Lopez Ankle and Foot
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Experimental
Arm Description
Patients in the control group will be treated with the current standard of care including shoe modification and home stretching exercises.
Patients assigned to the experimental group will receive the current standard of care as well as the Ankle Dorsiflexion Dynasplint.
Outcomes
Primary Outcome Measures
Range of Motion
The primary outcome is change in ankle range of motion
Secondary Outcome Measures
Pain
The secondary outcome will be change in pain scale rating as reported by patient
Full Information
NCT ID
NCT01238484
First Posted
November 9, 2010
Last Updated
July 10, 2013
Sponsor
Dynasplint Systems, Inc.
Collaborators
McMurry University
1. Study Identification
Unique Protocol Identification Number
NCT01238484
Brief Title
Ankle Equinus Contracture Treated With Dynamic Splinting
Official Title
Ankle Equinus Contracture Treated With Dynamic Splinting in a Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Why Stopped
Centers could not meet enrollment goals
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynasplint Systems, Inc.
Collaborators
McMurry University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Equinus, Ankle Contracture, Diabetes Mellitus
Keywords
Ankle Equinus, Ankle contracture, Diabetes Mellitus, Dynasplint, AFD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients in the control group will be treated with the current standard of care including shoe modification and home stretching exercises.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients assigned to the experimental group will receive the current standard of care as well as the Ankle Dorsiflexion Dynasplint.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
shoe modification home stretching exercises
Intervention Type
Device
Intervention Name(s)
Dynasplint
Intervention Description
shoe modification home stretching exercises Ankle Dorsiflexion Dynasplint
Primary Outcome Measure Information:
Title
Range of Motion
Description
The primary outcome is change in ankle range of motion
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Pain
Description
The secondary outcome will be change in pain scale rating as reported by patient
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Atlanta Foot and Leg Clinic
City
Jonesboro
State/Province
Georgia
ZIP/Postal Code
30236
Country
United States
Facility Name
Lopez Ankle and Foot
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76164
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12379973
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. doi: 10.1016/s0891-8422(02)00010-1.
Results Reference
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PubMed Identifier
12381796
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.
Results Reference
background
PubMed Identifier
12647847
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.
Results Reference
background
PubMed Identifier
11021048
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. doi: 10.7547/87507315-90-8-385.
Results Reference
background
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
Results Reference
background
PubMed Identifier
10693087
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. doi: 10.2519/jospt.2000.30.2.91.
Results Reference
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PubMed Identifier
16534718
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. doi: 10.1080/17453670610045867.
Results Reference
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PubMed Identifier
1783755
Citation
Grady JF, Saxena A. Effects of stretching the gastrocnemius muscle. J Foot Surg. 1991 Sep-Oct;30(5):465-9.
Results Reference
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PubMed Identifier
17665354
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. doi: 10.1055/s-2007-984418.
Results Reference
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PubMed Identifier
16476917
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.
Results Reference
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PubMed Identifier
19857837
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.
Results Reference
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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.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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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.
Results Reference
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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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Citation
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Citation
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Results Reference
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Ankle Equinus Contracture Treated With Dynamic Splinting
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