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

Dynasplint Systems, Inc.2 sites in 1 country15 target enrollmentAugust 2010

ConditionsAnkle Equinus Ankle Contracture Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ankle Equinus
Sponsor: Dynasplint Systems, Inc.
Enrollment: 15
Locations: 2
Primary Endpoint: Range of Motion
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

January 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dynasplint Systems, Inc.

Responsible Party

Sponsor

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.)