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临床试验/NCT05833295
NCT05833295尚未招募不适用

Electrophysiological and Clinical Effects of Walking Downhill in Stroke Patients

Marmara University2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2023年4月24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
21
试验地点
2
主要终点
the change in the H/M ratio after a 20-minute walk.

研究概览

简要总结

investigation of the effects of walking for 20 minutes on the acute H/M ratio on flat ground, downhill slopes at -7.5 degrees and -15 degrees in patients who have had a stroke, have spasticity and are ambulatory.

At the same time, the aim of the study is to obtain the clinical effectiveness of this walking pattern and control of the H/M ratio by checking the H/M ratio again after 5 sessions and 20 minutes of walking for the patients participating in the study.

详细描述

Participants will wear a seat belt connected to an overhead support and will walk on a treadmill with a dual-band instrument at a sampling frequency of 2000 Hz. The seat belt will only serve as a safety mechanism in case of a fall and will not support any body weight while walking. Each participant will walk for 20 minutes under one of 3 slope conditions; treadmill walking on 0° flat ground, , downhill walking with treadmill on -7.5° slope and downhill walking with treadmill on -15° slope.

First, by asking the participants to walk at their comfortable speed for straight walking on the treadmill with tools, the walking speed will be determined and carried out at the specified speeds. All self-selected walking speeds will be determined in two 30-second trials. During the 20-minute walk for each condition, if the participant needs to slow down, the speed of the treadmill will be reduced to adapt to this, and the average walking speed during the 20-minute walking session will be reported. Pulse and blood pressure will be monitored before, during and after the walk.

All participants will be evaluated with modified asworth scale, modified tardeu scale, 2 minute walking test, modified rankin scale, timed get up and walk test, fatigue impact scale, stroke impact scale, berg balance scale, fugl meyer assessment scale before treatment.

Patients will be randomized into 3 groups. Then, the H / M ratio will be looked at in all 3 groups. After the first walking session, the H / M ratio will be repeated. after completing the 5-session walking program, clinical and electrophysiological tests will be repeated.

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)

盲法说明

Patients will be randomized into 3 groups. Clinical and electrophysiological tests before and after walking sessions will be performed by an unannounced researcher.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients diagnosed with stroke between the ages of 18 and 65 Dec

排除标准

  • Other neurological disorders,
  • Expressive or receptive aphasias,
  • Severe heart disease,
  • A history of poorly controlled diabetes,
  • Active cancer,
  • Those who have been injected with botilinum toxin in the last 3 months,
  • Orthopedic conditions affecting the legs, a history of hip or knee replacement,
  • Serious simultaneous medical problems, such as peripheral nerve damage
  • Inability to comprehend verbal instructions

结局指标

主要结局

the change in the H/M ratio after a 20-minute walk.

时间窗: Day 5: The fifth day of the 20-minute walk

Each participant will be evaluated for changes in the H/M ratio with an EMG device before the walk, on the 1st day of the walk, and on the 5th day of the walk.

次要结局

  • Modified Tardeu Scale(Day 5: The fifth day of the 20-minute walk)
  • Walking test(Day 5: The fifth day of the 20-minute walk)
  • Walking capacity(Day 5: The fifth day of the 20-minute walk)
  • The Fatigue Effect Scale(Day 0: Before the walk)
  • Modified Asworth Scale(Day 5: The fifth day of the 20-minute walk)
  • Fatigue(Day 5: The fifth day of the 20-minute walk)
  • Fugl-Meyer Assessment Scale(Day 5: The fifth day of the 20-minute walk)
  • Stroke impact scale(Day 5: The fifth day of the 20-minute walk)
  • Berg Equilibrium Scale(Day 5: The fifth day of the 20-minute walk)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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