Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- A Repeated Measures Analysis of Variance (ANOVA)
研究概览
简要总结
To determine the efficacy of Metatarsal Dynasplint Sytem (MTP) in reducing contracture of hallux limitus secondary to Bunionectomy, in a longitudinal, controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Diagnosis 1st MTJ Contracture following Bunionectomy
排除标准
- •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
- •Treatment with electrical stimulation assisting ambulation (i.e Bioness, WalkAide, Parastep, etc.)
研究组 & 干预措施
control/ standard of care
ALL SUBJECTS WILL RECEIVE SHOE INSERTS AND HOME STRETCHING REGIME. Control subjects will be treated with the Standard of Care during the first 12 weeks, but after the 12 weeks patients will be fit with MTP, which delivers a low-load, prolonged-duration stretch after completion of this study.
干预措施: standard of care (Other)
Dynasplint
ALL SUBJECTS WILL RECEIVE SHOE INSERTS AND HOME STRETCHING REGIME. Experimental subjects will be immediated treated with the Metatarsal Dynasplint, which delivers a low-load, prolonged-duration stretch for 60 minutes, three times per day.
干预措施: Metarsal Dynasplint (Device)
结局指标
主要结局
A Repeated Measures Analysis of Variance (ANOVA)
时间窗: 12 months
ANOVA will be performed to measure different in category, pain, duration to full restoration of active range of motion(AROM).
次要结局
未报告次要终点