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临床试验/NCT01647321
NCT01647321已完成不适用

Evaluating the Effects of Functional Electrical Stimulation on Ambulation in Individuals With Secondary Progressive Multiple Sclerosis

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2012年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Change in timed 25 foot walk from baseline to end of training

研究概览

简要总结

Secondary progressive multiple sclerosis (SPMS) is a subtype of multiple sclerosis (MS) for which there are no existing therapies that alter the disease course. This research will utilize cutting edge functional electrical stimulation (FES) cycling technology with the goal of improving walking in individuals with SPMS. The investigators hypothesize that FES cycling will improve walking in subjects with SPMS.

详细描述

Individuals with secondary progressive multiple sclerosis (SPMS) experience significant impairments in ambulation leading to use of canes, walkers, and ultimately wheelchairs. Treatment attempts for progressive MS have been disappointing. No therapeutic intervention has been shown to modulate disability in patients with SPMS. FES cycling has been shown to have multiple primary medical benefits including: increased muscle mass, improvements in bone density, enhanced cardiovascular function, improved bowel function, decreased spasticity and reductions in bladder infection rate. More importantly FES may modulate the inflammatory central nervous system (CNS) environment in progressive MS. The investigators are proposing a novel, and easy to implement intervention strategy of FES cycling to help improve gait function in individuals with SPMS. A successful outcome on a larger SPMS population would have significant impact towards changing MS clinical care. FES is easily transferable to clinical practice and could potentially ameliorate other complications associated with SPMS such as spasticity, mood and fatigue reducing the burden of health care cost. In addition, the investigators will gain a better understanding of the mechanisms underlying these changes that could be used to design new therapeutic strategies.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 68 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •clinical diagnosis of secondary progressive multiple sclerosis
  • •males and females between the ages of 18 and 65 years
  • •Expanded disability status scale score between 5.0 and 7.0
  • •Able to consent to participate in study and are willing to undergo a lumbar puncture and blood draws
  • •If on on Ampyra or anti-spasticity agent, must be on stable dose for 1 month prior to screening
  • •No functional electrical stimulation use within 4 weeks
  • •Participants must be medically stable with no recent (1 month or less) inpatient admission for acute medical or surgical issues

排除标准

  • •Uncontrolled hypertension or other significant cardiovascular disease as determined by investigator
  • •History of epileptic seizures
  • •Subjects who have a pacemaker
  • •Relapse within thirty days prior to screening visit
  • •Pregnancy
  • •Subjects having a Stage 2 or greater sacral decubitus ulcer

研究组 & 干预措施

Active cycling

Active Comparator

Individuals will receive functional electrical stimulation while on the stationary bike and instructed to actively pedal.

干预措施: Active cycling (Behavioral)

Passive cycling

Sham Comparator

Individuals will receive active functional electrical stimulation (FES) while on the stationary bike and instructed to relax their legs, allowing the FES to move their legs on the stationary bike.

干预措施: Passive cycling (Behavioral)

结局指标

主要结局

Change in timed 25 foot walk from baseline to end of training

时间窗: Participants are assessed at baseline (visit 1), one-month (visit 2), two-months (visit 3), three-months (visit 4), end of study (visit 5)

Here we will assess whether a subjects walking speed is improved following active cycling with functional electrical stimulation. Our prediction is that individuals will improve in their walking function following seated active cycling with functional electrical stimulation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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