Shoulder Passive Range of Motion and Positioning Exercise on Hemiplegic Stroke Patients

Study Overview
=================
Brief Summary
-----------------
Several factors associated with the hemiplegic shoulder pain after stroke includes rotator cuff injury, bicipital tendonitis, impingement, spasticity, limited external rotation of shoulder joint, adhesive capsulitis, shoulder subluxation, shoulder hand syndrome, and brachial/axillary neuropathy. In this study, the investigators aim to usie high frequency ultrasound to evaluate the relationship between stroke patients with poor shoulder motor function and shoulder tendon injury. Also, assumed that performing passive range of motion and positioning training might prevent tendon injury of shoulder and hemiplegic shoulder pain in either acute or chronic stage of stroke.

Detailed Description
-----------------
Hemiplegic shoulder pain is a common complication. Several factors associated with the hemiplegic shoulder pain includes rotator cuff injury, bicipital tendonitis, impingement, spasticity, limited external rotation of shoulder joint, adhesive capsulitis, shoulder subluxation, shoulder hand syndrome, and brachial/axillary neuropathy. Flaccidity has a positive association with soft tissue injury or tendon injury of the shoulder. In the preliminary study, base on the sonography results, it is found that the possibility of getting tendon injury or inflammation on the affected shoulder joint is higher in the group of patients who were with worse motor functions during the rehabilitation in hospital. In this study, one hundred acute stroke patients with hemipelgia will be enrolled. And those participants would be separated into 2 groups: control group (Brunnstrom stage IV-VI) and experimental group (Brunnstrom stage I-III). Clinical characteristics and physical findings will be recorded on the admission date. During the process, the investigators will use high frequency (5-12 MHz) musculoskeletal ultrasound to evaluate those tendons around bilateral shoulder joints on the admission date and at 2 weeks later. In the first year after stroke, half patients in those 2 groups will perform positioning training and passive range of motion for affected shoulder either during hospitalization or after being discharged. Then, the investigators will execute physical examination and use high frequency ultrasound to evaluate those tendons around bilateral shoulder joints of the participants twice after 6 months and 12 months. Then, the investigators will discuss the incidences of shoulder tendon injury after receiving rehabilitation program according to ultra-sonographic findings.

Official Title
-----------------
Passive Range of Motion and Position Training for Stroke Patients With Hemiplegia to Prevent Shoulder Injury or Pain- Ultrasonographic Study

Conditions
-----------------
Shoulder Pain, Stroke, Hemiplegia, Rotator Cuff Injury

Intervention / Treatment
-----------------
* Other: video-teaching
* Other: oral-teaching
* Other: regular rehabilitation program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stroke with hemiplegia age between 18-80 Exclusion Criteria: recurrent stoke patient previous history of shoulder pain, any injuries and operation in shoulder joint, frozen shoulder, tendinitis in shoulder joint, any other systemic neuromuscular disease cognition or language impairment leading to communication difficulty

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: video-teaching materials<br>regular passive ROM exercise regular rehabilitation programe alternative video-teaching materials | Other: video-teaching<br>* By watching a video specially designed by a rehabilitation team, the participants may learn how to position their affected arm properly (30 minutes per time, twice a day for five days in a week), how to transfer safely with the help from the caregivers, how to execute appropriate passive range of motion exercises regularly (15 minutes per time, twice a day for five days in a week), and be taught to be aware of not doing insecure pulley exercises nor carrying stuffs which are too heavy.<br>Other: oral-teaching<br>* The nurses will teach patients how to position their affected arm properly, how to transfer safely with the help from the caregivers, how to execute appropriate passive range of motion exercises regularly, and be taught to be aware of not doing insecure pulley exercises nor carrying stuffs which are too heavy on the admission date of hospitalization.<br>Other: regular rehabilitation program<br>* Regular occupational therapy program and regular physical therapy program in the rehabilitation department of the hospital.<br>|
| Other: control group<br>regular passive ROM exercise regular rehabilitation programe regular oral-teaching materials | Other: oral-teaching<br>* The nurses will teach patients how to position their affected arm properly, how to transfer safely with the help from the caregivers, how to execute appropriate passive range of motion exercises regularly, and be taught to be aware of not doing insecure pulley exercises nor carrying stuffs which are too heavy on the admission date of hospitalization.<br>Other: regular rehabilitation program<br>* Regular occupational therapy program and regular physical therapy program in the rehabilitation department of the hospital.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change from baseline on hemiplegic upper extremity sonography | A doctor will use a high frequency(5-12 MHz) sonography examination machine(Terason t300, Teratech Co., USA) as the evaluation tool of this study. The target muscles and structures around affected shoulder includes biceps, supraspinatus, infraspinatus, subscapularis, sub-deltoid bursa and ACJ. | baseline (before intervention), changes from baseline sonography results at one week before being discharged and at six month after. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brunnstrom motor recovery stage for motor ability | A physical therapist will measure Brunnstrom motor recovery stage and see the improvement of it from baseline till one week before being discharged and after six months. | baseline (before intervention), changes from baseline Brunnstrom stage at one week before being discharged and at six month after. | 
| Modified Ashworth scale for level of spasticity of affected arm | A physical therapist will measure the level of spasticity in affected arm by using modified Ashworth scale. | baseline (before intervention), changes from baseline level of spasticity at one week before being discharged and at six month after. | 
| Range of motion | A physical therapist will measure range of motions of affected arm by using goniometry. | baseline (before intervention), changes from baseline range of motions at one week before being discharged and at six month after. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Hemiplegia, Rotator Cuff Injury