Ankle Equinus Contracture Treated With Dynamic Splinting

Dynasplint Systems.

Status: Terminated

Conditions: Ankle Equinus; Diabetes Mellitus; Ankle Contracture

Treatments: Device: Dynasplint; Other: Standard of care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01238484

2010:004

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Control

Active Comparator group

Description:

Patients in the control group will be treated with the current standard of care including shoe modification and home stretching exercises.

Treatment:

Other: Standard of care

Experimental

Experimental group

Description:

Patients assigned to the experimental group will receive the current standard of care as well as the Ankle Dorsiflexion Dynasplint.

Treatment:

Device: Dynasplint