Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available Ankle Foot Orthosis in Adult Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Step Time Symmetry
研究概览
简要总结
The purpose of this study is to evaluate how two different settings of a commercially available ankle foot brace affect how stroke patients walk. The study brace is an ankle foot orthosis (AFO) that makes use of a newer type of joint that contains a soft insert, in addition to the conventional hard stops, to limit the range of motion of the ankle during walking. The results of this study will help to clarify 1) whether and how this new joint affects the way you walk, 2) whether it makes it easier for the clinician to align your brace and 3) your opinions about the new joint.
详细描述
The purpose of this study is to evaluate how two different settings of a commercially available ankle foot brace affect how stroke patients walk. The study brace is an ankle foot orthosis (AFO) that makes use of a newer type of joint that contains a soft insert, in addition to the conventional hard stops, to limit the range of motion of the ankle during walking. Participants undergo testing in the gaitlab after using the new brace for a period of time. The results of this study will help to clarify 1) whether and how this new joint affects the way you walk, 2) whether it makes it easier for the clinician to align your brace and 3) your opinions about the new joint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 21 and 70 males and non-pregnant females
- •Diagnosis of stroke more than 1 year ago
- •Ambulatory at 0.5m/s or greater
- •Require unilateral AFOs to ambulate
- •Stable medical condition - no concomitant progressive diseases that could affect motor function
- •Ability to comply with directions and cooperate with research team
排除标准
- •Subjects who are currently receiving physical therapy for gait problems
- •Anticipated surgical or pharmacologic intervention for tone/contractures during the study period
- •Additional neurologic or musculoskeletal diagnoses that might impair gait (i.e., recent orthopedic interventions (6 weeks), unhealed fractures, significant degenerative joint disease, lower limb amputation, uncontrolled seizures)
- •Recent cardiac or active pulmonary disease, liable blood pressure
- •Recent back surgery
结局指标
主要结局
Step Time Symmetry
时间窗: 8 weeks
step time symmetry will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat). symmetry will result in a ratio of step time on more involved or affected side compared to the less involved or affected (i.e. the "normal") side. as such, the measure will appear to have no units but actually will be a ratio of the same units (in this case, seconds to seconds).
Self-selected Walking Velocity
时间窗: 8 weeks
walking velocity will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat)
Step Length Symmetry
时间窗: 8 weeks
step length symmetry will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat). symmetry will result in a ratio of step length on more involved or affected side compared to the less involved or affected (i.e. the "normal") side. as such, the measure will appear to have no units but actually will be a ratio of the same units (in this case, meters to meters).
次要结局
- Joint Kinematics(8 weeks)
- Joint Kinetics(8 weeks)
- Subject Opinions(8 weeks)
- Activity (Step Count)(8 weeks)
研究者
Mukul Talaty
Biomechanist
Albert Einstein Healthcare Network