Prospective Evaluation of Functional Performance in Patients With Lower Limb Orthoses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Zeno Walkway
研究概览
简要总结
This study is the first to assess the impact of lower extremity orthoses on gait and balance in individuals with CA. By investigating how orthoses influence mobility and stability, this research will provide critical data to inform clinical guidelines, improve patient care, and support evidence-based orthotic prescriptions for individuals with CA.
详细描述
This study is the first randomized controlled trial to evaluate the impact of orthoses on the gait and balance of individuals with ataxia. Prior studies have suggested that foot orthoses may provide stability to improve lower extremity mechanics2, 3 by potentially reducing degrees of freedom3 or by enhancing proprioceptive feedback12, 13, yet no clinical trials have systematically tested these effects in CA, a population with unique joint kinematics and sensory integration challenges. In general, there is a paucity of literature for individuals with CA.14 However, there are many neurologic diagnoses that find orthoses to be beneficial for balance,5, 15, 16 gait,17, 18 and functional mobility.19
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebellar ataxia diagnosed by a physician
- •Ambulatory for 16 feet (Zeno mat) with assistance and without assistive device(s)
- •18 years or older
排除标准
- •Gait velocity >/= 100 cm/sec without an assistive device
- •Medically diagnosed orthopedic conditions or injuries that impact ambulation
- •Unhealed wounds on the feet
结局指标
主要结局
Zeno Walkway
时间窗: Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.
This is kinematic gait information including gait velocity.
次要结局
- 6 MWT(Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.)
- Quebec User Evaluation of Satisfaction with Assistive Technology (survey)(After 14 days after wearing the orthosis.)
研究者
David Wilson
Associate Professor
University of Texas Southwestern Medical Center