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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
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Stroke, Hemiplegia, Rotator Cuff Injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 5, 2017
    Last Updated
    February 5, 2017
    Sponsor
    Chang Gung Memorial Hospital
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    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

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

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