Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial
NCT ID: NCT01589679
Last Updated: 2013-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
40 participants
INTERVENTIONAL
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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control/ standard of care
ALL SUBJECTS WILL RECEIVE SHOE INSERTS AND HOME STRETCHING REGIME. Control subjects will be treated with the Standard of Care during the first 12 weeks, but after the 12 weeks patients will be fit with MTP, which delivers a low-load, prolonged-duration stretch after completion of this study.
standard of care
Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is work for 60 minutes three times per day.
Dynasplint
ALL SUBJECTS WILL RECEIVE SHOE INSERTS AND HOME STRETCHING REGIME. Experimental subjects will be immediated treated with the Metatarsal Dynasplint, which delivers a low-load, prolonged-duration stretch for 60 minutes, three times per day.
Metarsal Dynasplint
Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is work for 60 minutes three times per day.
Interventions
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standard of care
Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is work for 60 minutes three times per day.
Metarsal Dynasplint
Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is work for 60 minutes three times per day.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
* Treatment with electrical stimulation assisting ambulation (i.e Bioness, WalkAide, Parastep, etc.)
18 Years
90 Years
ALL
No
Sponsors
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Dynasplint Systems, Inc.
INDUSTRY
Responsible Party
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Locations
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Tufts Medical Center
Boston, Massachusetts, United States
Brown Hand Center and Achilles Foot & Ankle Specialist
Henderson, Nevada, United States
Advanced Diagnostic Foot and Ankle Specialist of Cy-Fair
Houston, Texas, United States
Countries
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Other Identifiers
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DYN1-12-047
Identifier Type: -
Identifier Source: org_study_id