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

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ClinicalTrials.gov Identifier: NCT03045432
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Hemiplegia Stroke Rotator Cuff Injury Other: video-teaching Other: oral-teaching Other: regular rehabilitation program Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Passive Range of Motion and Position Training for Stroke Patients With Hemiplegia to Prevent Shoulder Injury or Pain- Ultrasonographic Study
Actual Study Start Date : August 1, 2007
Actual Primary Completion Date : July 31, 2008
Actual Study Completion Date : June 30, 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: video-teaching materials
  • regular passive ROM exercise
  • regular rehabilitation programe
  • alternative video-teaching materials
Other: video-teaching
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.

Other: oral-teaching
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.

Other: regular rehabilitation program
Regular occupational therapy program and regular physical therapy program in the rehabilitation department of the hospital.

control group
  • regular passive ROM exercise
  • regular rehabilitation programe
  • regular oral-teaching materials
Other: oral-teaching
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.

Other: regular rehabilitation program
Regular occupational therapy program and regular physical therapy program in the rehabilitation department of the hospital.




Primary Outcome Measures :
  1. the change from baseline on hemiplegic upper extremity sonography [ Time Frame: baseline (before intervention), changes from baseline sonography results at one week before being discharged and at six month after. ]
    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.


Secondary Outcome Measures :
  1. Brunnstrom motor recovery stage for motor ability [ Time Frame: baseline (before intervention), changes from baseline Brunnstrom stage at one week before being discharged and at six month after. ]
    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.

  2. Modified Ashworth scale for level of spasticity of affected arm [ Time Frame: baseline (before intervention), changes from baseline level of spasticity at one week before being discharged and at six month after. ]
    A physical therapist will measure the level of spasticity in affected arm by using modified Ashworth scale.

  3. Range of motion [ Time Frame: baseline (before intervention), changes from baseline range of motions at one week before being discharged and at six month after. ]
    A physical therapist will measure range of motions of affected arm by using goniometry.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045432


Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Yu Chi Huang, Bachelor Study Principal Investigator ChangGungMH

Publications:

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03045432     History of Changes
Other Study ID Numbers: NMRPG866091
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chang Gung Memorial Hospital:
Stroke
Hemiplegia
Rotator Cuff Injury

Additional relevant MeSH terms:
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Stroke
Shoulder Pain
Hemiplegia
Rotator Cuff Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Paralysis
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries