Shoulder Passive Range of Motion and Positioning Exercise on Hemiplegic Stroke Patients
Primary Purpose
Shoulder Pain, Hemiplegia, Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
video-teaching
oral-teaching
regular rehabilitation program
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Stroke, Hemiplegia, Rotator Cuff Injury
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
video-teaching materials
control group
Arm Description
regular passive ROM exercise regular rehabilitation programe alternative video-teaching materials
regular passive ROM exercise regular rehabilitation programe regular oral-teaching materials
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Range of motion
A physical therapist will measure range of motions of affected arm by using goniometry.
Full Information
NCT ID
NCT03045432
First Posted
February 5, 2017
Last Updated
February 5, 2017
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03045432
Brief Title
Shoulder Passive Range of Motion and Positioning Exercise on Hemiplegic Stroke Patients
Official Title
Passive Range of Motion and Position Training for Stroke Patients With Hemiplegia to Prevent Shoulder Injury or Pain- Ultrasonographic Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2007 (Actual)
Primary Completion Date
July 31, 2008 (Actual)
Study Completion Date
June 30, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Hemiplegia, Stroke, Rotator Cuff Injury
Keywords
Stroke, Hemiplegia, Rotator Cuff Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
video-teaching materials
Arm Type
Experimental
Arm Description
regular passive ROM exercise
regular rehabilitation programe
alternative video-teaching materials
Arm Title
control group
Arm Type
Other
Arm Description
regular passive ROM exercise
regular rehabilitation programe
regular oral-teaching materials
Intervention Type
Other
Intervention Name(s)
video-teaching
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
oral-teaching
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
regular rehabilitation program
Intervention Description
Regular occupational therapy program and regular physical therapy program in the rehabilitation department of the hospital.
Primary Outcome Measure Information:
Title
the change from baseline on hemiplegic upper extremity sonography
Description
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.
Time Frame
baseline (before intervention), changes from baseline sonography results at one week before being discharged and at six month after.
Secondary Outcome Measure Information:
Title
Brunnstrom motor recovery stage for motor ability
Description
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.
Time Frame
baseline (before intervention), changes from baseline Brunnstrom stage at one week before being discharged and at six month after.
Title
Modified Ashworth scale for level of spasticity of affected arm
Description
A physical therapist will measure the level of spasticity in affected arm by using modified Ashworth scale.
Time Frame
baseline (before intervention), changes from baseline level of spasticity at one week before being discharged and at six month after.
Title
Range of motion
Description
A physical therapist will measure range of motions of affected arm by using goniometry.
Time Frame
baseline (before intervention), changes from baseline range of motions at one week before being discharged and at six month after.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Chi Huang, Bachelor
Organizational Affiliation
Study Principal Investigator ChangGungMH
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
5156175
Citation
Najenson T, Yacubovich E, Pikielni SS. Rotator cuff injury in shoulder joints of hemiplegic patients. Scand J Rehabil Med. 1971;3(3):131-7. No abstract available.
Results Reference
background
PubMed Identifier
2431421
Citation
Griffin JW. Hemiplegic shoulder pain. Phys Ther. 1986 Dec;66(12):1884-93. doi: 10.1093/ptj/66.12.1884.
Results Reference
background
PubMed Identifier
3741075
Citation
Bohannon RW, Larkin PA, Smith MB, Horton MG. Shoulder pain in hemiplegia: statistical relationship with five variables. Arch Phys Med Rehabil. 1986 Aug;67(8):514-6.
Results Reference
background
PubMed Identifier
12017515
Citation
Turner-Stokes L, Jackson D. Shoulder pain after stroke: a review of the evidence base to inform the development of an integrated care pathway. Clin Rehabil. 2002 May;16(3):276-98. doi: 10.1191/0269215502cr491oa.
Results Reference
background
PubMed Identifier
11807352
Citation
Snels IA, Dekker JH, van der Lee JH, Lankhorst GJ, Beckerman H, Bouter LM. Treating patients with hemiplegic shoulder pain. Am J Phys Med Rehabil. 2002 Feb;81(2):150-60. doi: 10.1097/00002060-200202000-00013.
Results Reference
background
PubMed Identifier
3942479
Citation
Van Ouwenaller C, Laplace PM, Chantraine A. Painful shoulder in hemiplegia. Arch Phys Med Rehabil. 1986 Jan;67(1):23-6.
Results Reference
background
PubMed Identifier
15015899
Citation
Gilmore PE, Spaulding SJ, Vandervoort AA. Hemiplegic shoulder pain: implications for occupational therapy treatment. Can J Occup Ther. 2004 Feb;71(1):36-46. doi: 10.1177/000841740407100108.
Results Reference
background
PubMed Identifier
11022070
Citation
Snels IA, Beckerman H, Twisk JW, Dekker JH, Peter De Koning, Koppe PA, Lankhorst GJ, Bouter LM. Effect of triamcinolone acetonide injections on hemiplegic shoulder pain : A randomized clinical trial. Stroke. 2000 Oct;31(10):2396-401. doi: 10.1161/01.str.31.10.2396.
Results Reference
background
PubMed Identifier
3804600
Citation
Parker VM, Wade DT, Langton Hewer R. Loss of arm function after stroke: measurement, frequency, and recovery. Int Rehabil Med. 1986;8(2):69-73. doi: 10.3109/03790798609166178.
Results Reference
background
PubMed Identifier
8902421
Citation
Wanklyn P, Forster A, Young J. Hemiplegic shoulder pain (HSP): natural history and investigation of associated features. Disabil Rehabil. 1996 Oct;18(10):497-501. doi: 10.3109/09638289609166035.
Results Reference
background
PubMed Identifier
14669184
Citation
Lo SF, Chen SY, Lin HC, Jim YF, Meng NH, Kao MJ. Arthrographic and clinical findings in patients with hemiplegic shoulder pain. Arch Phys Med Rehabil. 2003 Dec;84(12):1786-91. doi: 10.1016/s0003-9993(03)00408-8.
Results Reference
background
PubMed Identifier
9798835
Citation
Ikai T, Tei K, Yoshida K, Miyano S, Yonemoto K. Evaluation and treatment of shoulder subluxation in hemiplegia: relationship between subluxation and pain. Am J Phys Med Rehabil. 1998 Sep-Oct;77(5):421-6. doi: 10.1097/00002060-199809000-00012.
Results Reference
background
PubMed Identifier
2375673
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.
Results Reference
background
PubMed Identifier
15706548
Citation
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. doi: 10.1016/j.apmr.2004.02.031.
Results Reference
background
PubMed Identifier
15674917
Citation
Ada L, Foongchomcheay A, Canning C. Supportive devices for preventing and treating subluxation of the shoulder after stroke. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD003863. doi: 10.1002/14651858.CD003863.pub2.
Results Reference
background
PubMed Identifier
17321820
Citation
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. doi: 10.1016/j.apmr.2006.12.007.
Results Reference
background
PubMed Identifier
9036910
Citation
Dekker JH, Wagenaar RC, Lankhorst GJ, de Jong BA. The painful hemiplegic shoulder: effects of intra-articular triamcinolone acetonide. Am J Phys Med Rehabil. 1997 Jan-Feb;76(1):43-8. doi: 10.1097/00002060-199701000-00008.
Results Reference
background
PubMed Identifier
17185637
Citation
Lindgren I, Jonsson AC, Norrving B, Lindgren A. Shoulder pain after stroke: a prospective population-based study. Stroke. 2007 Feb;38(2):343-8. doi: 10.1161/01.STR.0000254598.16739.4e. Epub 2006 Dec 21.
Results Reference
background
PubMed Identifier
2678248
Citation
Brandt TD, Cardone BW, Grant TH, Post M, Weiss CA. Rotator cuff sonography: a reassessment. Radiology. 1989 Nov;173(2):323-7. doi: 10.1148/radiology.173.2.2678248.
Results Reference
background
PubMed Identifier
3152389
Citation
Crass JR, Craig EV, Feinberg SB. Ultrasonography of rotator cuff tears: a review of 500 diagnostic studies. J Clin Ultrasound. 1988 Jun;16(5):313-27. doi: 10.1002/jcu.1870160506.
Results Reference
background
PubMed Identifier
7480690
Citation
van Holsbeeck MT, Kolowich PA, Eyler WR, Craig JG, Shirazi KK, Habra GK, Vanderschueren GM, Bouffard JA. US depiction of partial-thickness tear of the rotator cuff. Radiology. 1995 Nov;197(2):443-6. doi: 10.1148/radiology.197.2.7480690.
Results Reference
background
PubMed Identifier
15314536
Citation
Aras MD, Gokkaya NK, Comert D, Kaya A, Cakci A. Shoulder pain in hemiplegia: results from a national rehabilitation hospital in Turkey. Am J Phys Med Rehabil. 2004 Sep;83(9):713-9. doi: 10.1097/01.phm.0000138739.18844.88.
Results Reference
background
PubMed Identifier
12056171
Citation
Lee CL, Chen TW, Weng MC, Wang YL, Cheng HS, Huang MH. Ultrasonographic findings in hemiplegic shoulders of stroke patients. Kaohsiung J Med Sci. 2002 Feb;18(2):70-6.
Results Reference
background
PubMed Identifier
19253350
Citation
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.
Results Reference
background
Learn more about this trial
Shoulder Passive Range of Motion and Positioning Exercise on Hemiplegic Stroke Patients
We'll reach out to this number within 24 hrs