Ankle Contracture, Ankle Equinus, Diabetes Mellitus
Conditions
Keywords
Ankle Equinus, Ankle contracture, Diabetes Mellitus, Dynasplint, AFD
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.
Interventions
DEVICEDynasplint
shoe modification home stretching exercises Ankle Dorsiflexion Dynasplint
OTHERStandard of care
shoe modification home stretching exercises
Sponsors
McMurry University
Dynasplint Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion | 4 months | The primary outcome is change in ankle range of motion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 4 months | The secondary outcome will be change in pain scale rating as reported by patient |
Countries
United States
Outcome results
None listed