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临床试验/NCT01977287
NCT01977287已完成不适用

A Pilot Study to Assess the Effects of Using FES or AFO as an Assistive Mobility for Period of 12 Weeks for People With Multiple Sclerosis With Foot Drop

Queen Margaret University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Change in time taken for 10 meter walk test

研究概览

简要总结

This investigation consists of two parallel groups of participants who will follow the same protocol. The aim of the study is to investigate the effects of using Functional Electrical Stimulation/Ankle Foot Orthosis (AFO) or splint as an assistive mobility device over a 12 week period in people with MS who experience foot drop. Patients who are clinically prescribed FES will be invited to participate in the FES arm of the study. Patients who are clinically prescribed an AFO will be invited to participate in the AFO arm. Participants will be asked to make four visits to the gait laboratory at Queen Margaret University. Four weeks before the start of device use (Baseline - 4 weeks), start of device use (Baseline), after 6 weeks and 12 weeks of device use. Participants' walking will assessed using computerised three dimensional motion analysis, which will provide a detailed description of the movements (kinematics) of the lower limbs. Participants will also be asked to carry out a 10 metre walk and a two minute walk. Both gait analysis and the walking performance tests will be carried out with and without an assistive device; apart from their first session where participants will only be assessed without their assistive device.

Participants will be asked to wear an activity monitor for 7 days after each assessment. In addition participants will be asked to complete four short standardised questionnaires (MS walking scale, MS impact scale (MSIS-29), Fatigue severity score and the Leeds MS Quality of life score) at each assessment.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • People diagnosed with Multiple Sclerosis
  • Prescribed either AFO or FES to treat drop foot by their physiotherapist
  • aged 18-75

排除标准

  • Unable to walk 10 meters
  • Bilateral device use
  • Breastfeeding or pregnant

结局指标

主要结局

Change in time taken for 10 meter walk test

时间窗: change from baseline in 10m walk test at 12 weeks

In the 10 meter walk test, the time taken by the participant to walk 10 meters is recorded. The test is repeated and the average is taken for analysis.

次要结局

  • Change in ankle dorsiflexion angle at initial contact(The change from baseline of the ankle dorsiflexion angle at initial contact from at 12 weeks)

研究者

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

Marietta van der Linden

Dr

Queen Margaret University

研究点 (1)

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