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临床试验/NCT01238484
NCT01238484终止不适用

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

Dynasplint Systems, Inc.4 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
15
试验地点
4
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

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

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

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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