NCT01238484终止不适用
Ankle Equinus Contracture Treated With Dynamic Splinting in a Randomized, Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Range of Motion
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous Diagnosis Diabetes Mellitus
- •Reduced flexibility in AROM of extension in the ankle
- •Less than 10º Maximal, Active Dorsiflexion, while upright
- •Impaired gait pattern
排除标准
- •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
研究组 & 干预措施
Control
Active Comparator
Patients in the control group will be treated with the current standard of care including shoe modification and home stretching exercises.
干预措施: Standard of care (Other)
Experimental
Experimental
Patients assigned to the experimental group will receive the current standard of care as well as the Ankle Dorsiflexion Dynasplint.
干预措施: Dynasplint (Device)
结局指标
主要结局
Range of Motion
时间窗: 4 months
The primary outcome is change in ankle range of motion
次要结局
- Pain(4 months)
研究者
研究点 (2)
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