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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045432
• Other study ID #: NMRPG866091
• Status: Completed
• Phase: N/A
• First received: February 5, 2017
• Last updated: February 5, 2017
• Start date: August 1, 2007
• Est. completion date: June 30, 2009

Study information

• Verified date: January 2017
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 30, 2009
• Est. primary completion date: July 31, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Rotator Cuff Injury
• Shoulder Pain
• Stroke
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

References & Publications (24)

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Ada L, Goddard E, McCully J, Stavrinos T, Bampton J. Thirty minutes of positioning reduces the development of shoulder external rotation contracture after stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2005 Feb;86(2):230-4. — View Citation

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Chae J, Mascarenhas D, Yu DT, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Fang ZP. Poststroke shoulder pain: its relationship to motor impairment, activity limitation, and quality of life. Arch Phys Med Rehabil. 2007 Mar;88(3):298-301. — View Citation

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Gilmore PE, Spaulding SJ, Vandervoort AA. Hemiplegic shoulder pain: implications for occupational therapy treatment. Can J Occup Ther. 2004 Feb;71(1):36-46. Review. — View Citation

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Pong YP, Wang LY, Wang L, Leong CP, Huang YC, Chen YK. Sonography of the shoulder in hemiplegic patients undergoing rehabilitation after a recent stroke. J Clin Ultrasound. 2009 May;37(4):199-205. doi: 10.1002/jcu.20573. — View Citation

Poulin de Courval L, Barsauskas A, Berenbaum B, Dehaut F, Dussault R, Fontaine FS, Labrecque R, Leclerc C, Giroux F. Painful shoulder in the hemiplegic and unilateral neglect. Arch Phys Med Rehabil. 1990 Aug;71(9):673-6. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.