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临床试验/NCT07724093
NCT07724093尚未招募不适用

The Effects of a Powered Hip Flexion Orthosis on Gait in Persons With Multiple Sclerosis: a Case Series

University of Dayton1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年7月15日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kurt Jackson

Professor - Department of Physical Therapy

University of Dayton

研究点 (1)

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