Sonographic Evaluation of the Effect of Shoulder Orthosis on the Subluxation in Stroke Patients (SinSbyS&Co)
Primary Purpose
Stroke Patients
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
actimove sling
shoulderlift
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke Patients
Eligibility Criteria
Inclusion Criteria:
- First stroke
- Patients must be able to sit independently on a chair with arm support during 30 minutes
Exclusion Criteria:
- No shoulder problems prior to stroke
- No severe cognitive problems that make it impossible to understand brief commands;
Sites / Locations
- Ghent University Hospital, Department of Physical and Rehabilitation Medicine
- Ghent University, Department of Rehabilitation Sciences and Physiotherapy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
No Intervention
Arm Label
actimove sling
shoulderlift
controle group
Arm Description
standard orthosis: actimove sling
newly developed orthosis: shoulderlift
no orthosis
Outcomes
Primary Outcome Measures
Acromio - humeral distance
Acromio - humeral distance
Secondary Outcome Measures
Spasticity
Modified Ashworth Scale
Passive Range of motion
goniometric measurement
Trunk stability
Trunk Impairment Scale
comfort of the upper limb
Pain and comfort questionnaire
Balance
Gait characteristics
Measurement: Gait Rite
Spasticity
Modified Ashworth Scale
Passive Range of motion
goniometric measurement
Trunk stability
Trunk Impairment Scale
comfort of the upper limb
Pain and comfort questionnaire
Balance
Gait characteristics
Measurement: Gait Rite
Pain of the upper limb
Pain and comfort questionnaire
Pain of the upper limb
Pain and comfort questionnaire
Full Information
NCT ID
NCT02102269
First Posted
March 17, 2014
Last Updated
December 13, 2022
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT02102269
Brief Title
Sonographic Evaluation of the Effect of Shoulder Orthosis on the Subluxation in Stroke Patients
Acronym
SinSbyS&Co
Official Title
Sonographic Evaluation of the Effect of Shoulder Orthosis on the Subluxation in Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
September 27, 2021 (Actual)
Study Completion Date
September 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Shoulder pain is frequently reported as a complication among stroke patients. Muscular imbalance disrupts stability of the glenohumeral joint creating a subluxation. Stretching the soft tissue can cause shoulder pain which impedes quality of life, length of stay and rehabilitation outcome. To align the humeral head in the cavitas glenoïdalis a shoulder orthosis is often provided to the patient. Since the use of these orthoses is not always considered positive by the patient nor the therapist the question rises if the investigators can objectify if the subacromial space is reduced when wearing a sling.
Sonography is a valid way to asses subluxation of the shoulder joint by measuring the subacromial space. To objectify if an orthosis can reduce the enlarged subacromial space the investigators will use sonography to measure the distance between acromion and greater tuberosity are between acromion and the humeral head. This distance will be measured with and without the orthosis and also after a period of at least 4 hours of wearing the orthosis. This last measurement might inform us about how long the orthosis can correct the glenohumeral position. To validate the sonographic measurement X-rays will be taken by a sample of the investigators study population to compare with the ultrasound data.
Two different orthoses will be compared. First of all the actimove sling, which is standardly used in the rehabilitation centre where patients will be recruited. This sling can be adapted by the patient itself and is very easy to wear. The disadvantage is that the elbow is continuously flexed, which enlarges the risk on contractures of m. biceps and m. brachioradialis. Also the negative influence on the interpretation of the body scheme and on the quantitative use of the arm can be reasons not to wear this kind of orthosis. The shoulderlift on the other hand is a newly developed orthosis which supports the shoulder joint with the arm extended. This is a more normal position during the daily living and stimulates the use of the paretic arm. An extra adaptation can be adjusted to make it possible to position the arm flexed in order to reduce oedema of the hand if necessary. The control group does not wear any orthosis at all.
Additional the investigators will evaluate passive range of motion of the shoulder, spasticity of the upper limb (modified ashworth scale), active motion of the upper limb (fugl meyer assessment) and trunk stability (Trunk Impairment Scale) at starting point and after a period of 6 weeks wearing the orthosis minimal 6 hours a day.
If possible the investigators will do an evaluation of balance on a moving platform and an evaluation of gait with and without the orthosis after 6 weeks to assess the impact of on balance and gait.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Patients
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
actimove sling
Arm Type
Active Comparator
Arm Description
standard orthosis: actimove sling
Arm Title
shoulderlift
Arm Type
Experimental
Arm Description
newly developed orthosis: shoulderlift
Arm Title
controle group
Arm Type
No Intervention
Arm Description
no orthosis
Intervention Type
Device
Intervention Name(s)
actimove sling
Intervention Type
Device
Intervention Name(s)
shoulderlift
Primary Outcome Measure Information:
Title
Acromio - humeral distance
Time Frame
at 9 weeks after admission in the rehabilitation center
Title
Acromio - humeral distance
Time Frame
at 3 weeks after admission in the rehabilitation center
Secondary Outcome Measure Information:
Title
Spasticity
Description
Modified Ashworth Scale
Time Frame
at 9 weeks after admission in the rehabilitation center
Title
Passive Range of motion
Description
goniometric measurement
Time Frame
at 9 weeks after admission in the rehabilitation center
Title
Trunk stability
Description
Trunk Impairment Scale
Time Frame
at 9 weeks after admission in the rehabilitation center
Title
comfort of the upper limb
Description
Pain and comfort questionnaire
Time Frame
at 9 weeks after admission in the rehabilitation center
Title
Balance
Time Frame
at 9 weeks after admission in the rehabilitation center
Title
Gait characteristics
Description
Measurement: Gait Rite
Time Frame
at 9 weeks after admission in the rehabilitation center
Title
Spasticity
Description
Modified Ashworth Scale
Time Frame
at 3 weeks after admission in the rehabilitation center
Title
Passive Range of motion
Description
goniometric measurement
Time Frame
at 3 weeks after admission in the rehabilitation center
Title
Trunk stability
Description
Trunk Impairment Scale
Time Frame
at 3 weeks after admission in the rehabilitation center
Title
comfort of the upper limb
Description
Pain and comfort questionnaire
Time Frame
at 3 weeks after admission in the rehabilitation center
Title
Balance
Time Frame
at 3 weeks after admission in the rehabilitation center
Title
Gait characteristics
Description
Measurement: Gait Rite
Time Frame
at 3 weeks after admission in the rehabilitation center
Title
Pain of the upper limb
Description
Pain and comfort questionnaire
Time Frame
at 3 weeks after admission in the rehabilitation center
Title
Pain of the upper limb
Description
Pain and comfort questionnaire
Time Frame
at 9 weeks after admission in the rehabilitation center
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
First stroke
Patients must be able to sit independently on a chair with arm support during 30 minutes
Exclusion Criteria:
No shoulder problems prior to stroke
No severe cognitive problems that make it impossible to understand brief commands;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Cambier, MD, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital, Department of Physical and Rehabilitation Medicine
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Ghent University, Department of Rehabilitation Sciences and Physiotherapy
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Sonographic Evaluation of the Effect of Shoulder Orthosis on the Subluxation in Stroke Patients
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