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临床试验/NCT05767437
NCT05767437已完成不适用

The Effects of Reaching Task Following Selective Trunk Stability Exercise in Chronic Stroke Survivors

University of Valencia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年8月10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
20
试验地点
1
主要终点
The Effect of a Particular Intervention During the Entire Course of the study_Trunk Dislocation

研究概览

简要总结

This study is performed in a controlled randomized, two-period crossover design to test the efficacy of Abdominal drawing-in maneuver (ADIM) exercise compared to conventional physiotherapy in chronic stroke survivors.

详细描述

All participants provided written informed consent and are assigned to Group A or Group B. The inclusion criteria are Exclusion criteria are

Abdominal drawing-in maneuver exercise is following as:

It's for strengthening the Transversus Abdominis muscle(TrA). The simple device, that observes the pressure changes by the gauge. Subjects receive intervention 2 times a week for 4 weeks. Each session is 40 minutes. From the supine position to the hook-lying position (hip joint at 40 degrees and the knee joint at 80 degrees) and pull the navel deeply to the lumbar region through the Stabilizer™ Pressure Biofeedback that stabilizes transversus abdominis muscle. At this time, subjects are controlled to maintain contraction while keep breathing lightly, to contract slowly, also to not move the pelvis and chest while exercising The device assists in body control movements of the spine and abdominal muscle.

Conventional physiotherapy is following as:

Release pain, limb stretching, mobilization of joint and pelvic movement. Subjects receive 2 times a week for 4 weeks. Each session is 40 minutes. Group A received Abdominal drawing-in maneuver exercise for 4 weeks on period 1. Afterward washout period in a month, follow period 2 of conventional physiotherapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Double-blind.

入排标准

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

入选标准

  • •The subject consisted of the physician's confirmation of chronic hemiplegia
  • •onset ≥ 6 months
  • •Mini-mental state examination≥25
  • •Biceps ≤2, Triceps≤2
  • •Ability to Sit on a chair alone
  • •FMA UE score ≥ 21points, FMA UE≤ 60 points

排除标准

  • •Biceps>2, Triceps>2
  • •Neglect syndrome
  • •Have neurological disease and orthopedic disease
  • •Lack of coordination

研究组 & 干预措施

Abdominal drawing-in maneuver exercise, afterward Sham therapy(conventional physiotherapy)

Experimental

Participants first received Abdominal drawing-in maneuver exercise 2 times a week for 4 weeks. Each session is 40 minutes for additional 10 min with conventional therapy. Afterward a washout period of one month, they then received sham therapy (conventional therapy_release pain or upper limb mobilization) 2 times a week for 4 weeks. Each session is 40 minutes.

干预措施: Abdominal drawing-in maneuver exercise (Behavioral)

Abdominal drawing-in maneuver exercise, afterward Sham therapy(conventional physiotherapy)

Experimental

Participants first received Abdominal drawing-in maneuver exercise 2 times a week for 4 weeks. Each session is 40 minutes for additional 10 min with conventional therapy. Afterward a washout period of one month, they then received sham therapy (conventional therapy_release pain or upper limb mobilization) 2 times a week for 4 weeks. Each session is 40 minutes.

干预措施: sham (Behavioral)

Sham therapy(conventional physiotherapy), afterward Abdominal drawing-in maneuver exercise

Experimental

Participants first received sham therapy(release pain or upper limb mobilization)2 times a week for 4 weeks. Each session is 40 minutes. Afterward a washout period of one month, they then received Abdominal drawing-in maneuver exercise 2 times a week for 4 weeks. Each session is 40 minutes for additional 10 min with conventional therapy

干预措施: Abdominal drawing-in maneuver exercise (Behavioral)

Sham therapy(conventional physiotherapy), afterward Abdominal drawing-in maneuver exercise

Experimental

Participants first received sham therapy(release pain or upper limb mobilization)2 times a week for 4 weeks. Each session is 40 minutes. Afterward a washout period of one month, they then received Abdominal drawing-in maneuver exercise 2 times a week for 4 weeks. Each session is 40 minutes for additional 10 min with conventional therapy

干预措施: sham (Behavioral)

结局指标

主要结局

The Effect of a Particular Intervention During the Entire Course of the study_Trunk Dislocation

时间窗: Baseline, two period(each 4weeks), wash out(4weeks)

We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%. Participants who received that particular intervention during the entire course of the study. Effect of Abdominal Drawing-In Maneuver (AIDM) exercise and Shan therapy. Dislocation distance in millimeters(mm) for reaching phase

The Effect of a Particular Intervention During the Entire Course of the Study_movement Unit

时间窗: Baseline, two period(each 4weeks), wash out(4weeks)

We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%. It was defined by velocity peaks exceeding 20mm/s, with a minimum 150 ms interval. Participants who received that particular intervention during the entire course of the study. Number of movement units for reaching phase

The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angle

时间窗: Baseline, two period(each 4weeks), wash out(4weeks)

We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10% Elbow angle in degree for reaching phase Participants who received that particular intervention during the entire course of the study. -elbow angle: joining vector of acromion to lateral epicondyle and vector of lateral epicondyle and medial styloid process.

次要结局

  • The Effect of a Particular Intervention During the Entire Course of the Study_Total Time(Baseline, two period(each 4weeks), wash out(4weeks))
  • The Effect of a Particular Intervention During the Entire Course of the Study_Hand Velocity(Baseline, two period(each 4weeks), wash out(4weeks))
  • The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angular Velocity(Baseline, two period(each 4weeks), wash out(4weeks))

研究者

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

José Casaña Granell

Professor

University of Valencia

研究点 (1)

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