The Effects of Reaching Task Following Selective Trunk Stability Exercise

Study Overview
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Brief Summary
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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.

Detailed Description
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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. On the other side, Group B receives first conventional physiotherapy on period 1. Afterward washout period in a month, follow period 2 of Abdominal drawing-in maneuver exercise.

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

Conditions
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Cerebral Stroke, Hemiplegia, Spastic

Intervention / Treatment
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* Behavioral: Abdominal drawing-in maneuver exercise
* Behavioral: sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Biceps>2, Triceps>2 Flaccid Neglect syndrome Have neurological disease and orthopedic disease Lack of coordination

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: One group is the abdominal drawing-in maneuver exercise, afterward conventional physiotherapy in Participants With stroke survivors. On the contrary, Another group is conventional physiotherapy afterward the abdominal drawing-in maneuver exercise.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abdominal drawing-in maneuver exercise, afterward Sham therapy(conventional physiotherapy)<br>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. | Behavioral: Abdominal drawing-in maneuver exercise<br>* 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 stabilize 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<br>* Other names: Stabilizer pressure biofeedback;Behavioral: sham<br>* Release pain or upper limb mobilization<br>* Other names: Conventional therapy;|
| Experimental: Sham therapy(conventional physiotherapy), afterward Abdominal drawing-in maneuver exercise<br>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 | Behavioral: Abdominal drawing-in maneuver exercise<br>* 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 stabilize 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<br>* Other names: Stabilizer pressure biofeedback;Behavioral: sham<br>* Release pain or upper limb mobilization<br>* Other names: Conventional therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in compensatory trunk dislocation at 4weeks | Dislocation distance in millimeters(mm) for reaching phase | Baseline, two period(each 4weeks), wash out(4weeks) | 
| Change from baseline in smoothness movement at 4weeks | Number of movement units for reaching phase | Baseline, two period(each 4weeks), wash out(4weeks) | 
| Change from baseline in elbow angle at 4weeks | Elbow angle in degree for reaching phase -elbow angle: joining vector of acromion to lateral epicondyle and vector of lateral epicondyle and medial styloid process. | Baseline, two period(each 4weeks), wash out(4weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in reaching time at 4weeks | Duration of time in second(s) for reaching phase | Baseline, two period(each 4weeks), wash out(4weeks) | 
| Change from baseline in peak velocity at 4weeks | Hand distance and duration of time are combined in mm/s for reaching phase | Baseline, two period(each 4weeks), wash out(4weeks) | 
| Change from baseline in elbow angular velocity at 4weeks | Change in elbow angle and time rate are combined in rad/s for reaching phase | Baseline, two period(each 4weeks), wash out(4weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reaching task, Abdominal drawing-in maneuver, ADIM, Chronic stroke