The Effects of a Powered Hip Flexion Orthosis on Gait in Persons With Multiple Sclerosis: a Case Series
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Gait speed
研究概览
简要总结
The purpose of this study is to assess the immediate effects of a commercially available non-FDA regulated powered hip flexion assist device (Hypershell X, Shenzhen, China) on walking ability in persons with MS. The main question it aims to answer is: Does a powered hip flexion device provide immediate improvements in walking ability over short distances for people with MS?
详细描述
Individuals with multiple sclerosis (MS) frequently experience problems with walking that may include difficulty with advancing the leg during the swing phase of gait which can lead to a loss of independence and a higher risk of falls. To improve walking ability in this population, devices such as ankle-foot orthoses (AFO) and functional electrical stimulation (FES) are commonly used. However, recent advances in technology and robotics have led to the development of affordable and commercially available battery powered exoskeletons marketed towards improving activities such as hiking, running and cycling. There is emerging but limited evidence that hip flexion-assisting devices can modify kinematics and muscle activity during gait in people with MS, with several small-scale studies showing tolerability and shifts toward more normal hip motion during walking. However, there are no studies on the use of new commercially available powered hip flexion assist devices. Therefore, the purpose of this case series is to assess the immediate effects on walking ability of a commercially available, non-FDA regulated, powered hip flexion assist device (Hypershell X, Shenzhen, China).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80
- •Diagnosis of relapsing remitting, primary progressive or secondary progressive MS
- •Unilateral or bilateral hip flexion weakness (Manual muscle testing score of 3 or less)
- •Ability to walk at least 30 meters without requiring rest and without physical support or assistance from another person.
- •Waist circumference 26-48", Height 5 '- 6'2", Weight 100-230lbs
排除标准
- •Prior regular use of a hip flexion orthosis within the past 6 months.
- •Cognitive or communication deficits that would limit ability to participate safely.
- •Significant pain or deformity of the lower extremities that could impact walking ability.
- •Severe spasticity (Modified Ashworth Score of 3 or 4) of the hips or lower extremities that could impact walking ability.
- •Any other neurological conditions that may affect gait.
结局指标
主要结局
Gait speed
时间窗: Day 1 (immediate effect of device use)
Gait speed measured during a 10 meter walk
Foot clearance
时间窗: Day 1 (immediate effect of device use)
Distance that the foot clears the ground during the swing phase of gait
次要结局
- Step length(Day 1 (immediate effect of device use))
- Circumduction(Day 1 (immediate effect of device use))
- Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)(Day 1 (immediate effect of device use))
研究者
Kurt Jackson
Professor - Department of Physical Therapy
University of Dayton
