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临床试验/NCT05529498
NCT05529498招募中不适用

Effect of High Intensity Interval Gait Training on Ambulation in MS

City University of New York1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年9月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
6 minute walk test

研究概览

简要总结

Over 90% of persons with MS (pwMS) complain of difficulty with walking. High intensity interval gait training (HIIGT), where persons alternate brief periods of walking at high speeds with periods of rest has been found to improve walking in other neurologic diagnoses. However its impact on pwMS is not known. Most gait training in MS is done continuously at a slower pace. The purpose of this study is to compare the effects of HIIGT to traditional Moderate Intensity Continuous Gait Training (MICGT) in pwMS.

详细描述

Purpose: To determine whether pwMS will have greater improvements in gait with HIIGT as compared to MICGT.

Primary Question: Does HIIGT results in greater improvements in gait parameters in pwMS than MICGT? Secondary question: Will HIIGT result in greater improvements in balance, lower extremity strength, lower extremity range of motion and HR when compared to MICGT in pwMS?

Hypothesis: HIIGT will result in greater improvements in gait parameters in pwMS than MICGT.

Justification: Previous research has shown that MICGT, moderate intensity interval training and high intensity non-gait interval training is effective in pwMS (1)(2). HIIGT has been shown to be effective in persons with stroke (3) but the effects of HIIGT on pwMS are not known.

Outcomes and dissemination of information: We will present our findings at national conferences and submit manuscripts of our findings to the appropriate peer reviewed journal.

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
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persons diagnosed with Multiple Sclerosis. Rationale:because we are studying effects of the intervention on participant with MS
  • The ability to walk for 6 minutes continuously with or without assistive device. Rationale:we are using the 6MWT as our primary outcome measure
  • The ability to read, understand and sign a consent form so that they are able to understand the study we are doing
  • Above the age of 18 because they have to be able to give consent for the study
  • English speaking as we do not have the resources for translation for the multiple sessions this study entails

排除标准

  • Any cardiopulmonary, orthopedic, or non-MS neurologic disease as we are only examining the effects of MS and need to rule out the impact of other conditions
  • Report of a recent exacerbation. Rationale: the impact of the rationale can interfere with the impact of the independent variables

结局指标

主要结局

6 minute walk test

时间窗: 6 minutes

Distance covered during continuous walking for 6 minutes

次要结局

  • Finctional gait assessment(10 minutes)

研究者

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

Herbert Karpatkin

Associate Professor

City University of New York

研究点 (1)

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