Back to resultsComparing Mobilization Techniques for the Hemiplegic Shoulder
Primary Purpose
Hemiplegic Shoulder, Mobility Limitation
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Glenohumeral mobilization
Scapular mobilization
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegic Shoulder
Eligibility 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
Sites / Locations
- Vakgroep Revaki - Ghent University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Angular mobilization
Angular mobilization with soft tissue techniques
Scapular mobilization
Arm Description
Angular mobilization of the shoulder joint in the frontal plane.
Angular mobilization performed in the scapular plane. Additional soft tissue techniques to eliminate limitations created by tensed muscles in order to perform capsular stretch.
Scapular mobilization without glenohumeral movement.
Outcomes
Primary Outcome Measures
Range of motion of the shoulder using goniometry
Range of motion of the shoulder joint is measured using a goniometer
Shoulder pain using visual analogue scale
Shoulder pain during rest, night and activities by using visual analogue scale (0-10)
Secondary Outcome Measures
Spasticity of the shoulder muscles using the Modified Ashworth Scale
Spasticity of upper limb muscles related to the shoulder using Modified Ashworth Scale
Trunk Impairment Scale to assess trunk stability
Trunk stability using the Trunk Impairment Scale
Fugl-Meyer Assessment - upper limb part to assess voluntary muscle activity
voluntary muscle activity upper limb using the upper limb part of the Fugl-Meyer Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03211364
Brief Title
Comparing Mobilization Techniques for the Hemiplegic Shoulder
Official Title
Comparing Mobilization Techniques for the Hemiplegic Shoulder
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
November 7, 2017 (Actual)
Study Completion Date
November 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Shoulder, Mobility Limitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Patients do not know what are the intervention techniques or what is the control technique.
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Angular mobilization
Arm Type
Active Comparator
Arm Description
Angular mobilization of the shoulder joint in the frontal plane.
Arm Title
Angular mobilization with soft tissue techniques
Arm Type
Active Comparator
Arm Description
Angular mobilization performed in the scapular plane. Additional soft tissue techniques to eliminate limitations created by tensed muscles in order to perform capsular stretch.
Arm Title
Scapular mobilization
Arm Type
Placebo Comparator
Arm Description
Scapular mobilization without glenohumeral movement.
Intervention Type
Other
Intervention Name(s)
Glenohumeral mobilization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Scapular mobilization
Primary Outcome Measure Information:
Title
Range of motion of the shoulder using goniometry
Description
Range of motion of the shoulder joint is measured using a goniometer
Time Frame
Measuring every 4 weeks up to 12 weeks after admission to the study protocol
Title
Shoulder pain using visual analogue scale
Description
Shoulder pain during rest, night and activities by using visual analogue scale (0-10)
Time Frame
Measuring every 4 weeks up to 12 weeks after admission to the study protocol
Secondary Outcome Measure Information:
Title
Spasticity of the shoulder muscles using the Modified Ashworth Scale
Description
Spasticity of upper limb muscles related to the shoulder using Modified Ashworth Scale
Time Frame
Measuring every 4 weeks up to 12 weeks after admission to the study protocol
Title
Trunk Impairment Scale to assess trunk stability
Description
Trunk stability using the Trunk Impairment Scale
Time Frame
Measuring every 4 weeks up to 12 weeks after admission to the study protocol
Title
Fugl-Meyer Assessment - upper limb part to assess voluntary muscle activity
Description
voluntary muscle activity upper limb using the upper limb part of the Fugl-Meyer Scale
Time Frame
Measuring every 4 weeks up to 12 weeks after admission to the study protocol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Cambier, Prof
Organizational Affiliation
University Ghent
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kristine Oostra, Dr
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vakgroep Revaki - Ghent University
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Comparing Mobilization Techniques for the Hemiplegic Shoulder
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