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Comparing Mobilization Techniques for the Hemiplegic Shoulder

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ClinicalTrials.gov Identifier: NCT03211364
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
University Ghent

Brief Summary:
One of the main complications after stroke is hemiplegic shoulder pain. It is known that one of the most frequent causes of hemiplegic shoulder pain is a restricted range of motion in the shoulder joint. Therefore, it is necessary to preserve the passive range of motion by using the most optimal mobilization technique. The aim of this study is to compare 2 different techniques in order to document their influence on shoulder range of motion and shoulder pain in stroke patients.

Condition or disease Intervention/treatment Phase
Hemiplegic Shoulder Mobility Limitation Other: Glenohumeral mobilization Other: Scapular mobilization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description: Patients do not know what are the intervention techniques or what is the control technique.
Primary Purpose: Treatment
Official Title: Comparing Mobilization Techniques for the Hemiplegic Shoulder
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : November 7, 2017
Actual Study Completion Date : November 7, 2017

Arm Intervention/treatment
Active Comparator: Angular mobilization
Angular mobilization of the shoulder joint in the frontal plane.
Other: Glenohumeral mobilization
Comparing the effect of angular mobilization in frontal or scapular plane and of providing soft tissue techniques on hemiplegic shoulder range of motion and pain.

Active Comparator: Angular mobilization with soft tissue techniques
Angular mobilization performed in the scapular plane. Additional soft tissue techniques to eliminate limitations created by tensed muscles in order to perform capsular stretch.
Other: Glenohumeral mobilization
Comparing the effect of angular mobilization in frontal or scapular plane and of providing soft tissue techniques on hemiplegic shoulder range of motion and pain.

Placebo Comparator: Scapular mobilization
Scapular mobilization without glenohumeral movement.
Other: Scapular mobilization



Primary Outcome Measures :
  1. Range of motion of the shoulder using goniometry [ Time Frame: Measuring every 4 weeks up to 12 weeks after admission to the study protocol ]
    Range of motion of the shoulder joint is measured using a goniometer

  2. Shoulder pain using visual analogue scale [ Time Frame: Measuring every 4 weeks up to 12 weeks after admission to the study protocol ]
    Shoulder pain during rest, night and activities by using visual analogue scale (0-10)


Secondary Outcome Measures :
  1. Spasticity of the shoulder muscles using the Modified Ashworth Scale [ Time Frame: Measuring every 4 weeks up to 12 weeks after admission to the study protocol ]
    Spasticity of upper limb muscles related to the shoulder using Modified Ashworth Scale

  2. Trunk Impairment Scale to assess trunk stability [ Time Frame: Measuring every 4 weeks up to 12 weeks after admission to the study protocol ]
    Trunk stability using the Trunk Impairment Scale

  3. Fugl-Meyer Assessment - upper limb part to assess voluntary muscle activity [ Time Frame: Measuring every 4 weeks up to 12 weeks after admission to the study protocol ]
    voluntary muscle activity upper limb using the upper limb part of the Fugl-Meyer Scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First stroke
  • Upper limb impairment

Exclusion Criteria:

  • Shoulder pain on the hemiplegic side with onset before the stroke
  • Surgery at the hemiplegic shoulder
  • Active movement possible within the whole range of motion

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): NCT03211364


Locations
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Belgium
Vakgroep Revaki - Ghent University
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
Investigators
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Study Chair: Dirk Cambier, Prof University Ghent
Principal Investigator: Kristine Oostra, Dr University Hospital, Ghent
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT03211364    
Other Study ID Numbers: 2016/0404
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mobility Limitation
Signs and Symptoms