Stroke PatientsSinSbyS&CoNCT02102269
Sonographic Evaluation of the Effect of Shoulder Orthosis on the Subluxation in Stroke Patients
A study testing actimove sling and shoulderlift in people with Stroke Patients, run by University Hospital, Ghent at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke Patients
- What is being tested?
- actimove sling and shoulderlift
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesBelgium
- Study dates
- Jan 2014to 27 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First stroke
- Patients must be able to sit independently on a chair with arm support during 30 minutes
Who cannot join
- No shoulder problems prior to stroke
- No severe cognitive problems that make it impossible to understand brief commands;
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ghent University Hospital, Department of Physical and Rehabilitation Medicine
Ghent, 9000
Ghent University, Department of Rehabilitation Sciences and Physiotherapy
Ghent, 9000
About this study
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.
Read more
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.
- Conditions
- Stroke Patients
- Being tested
- actimove sling, shoulderlift
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
actimove slingDevice
shoulderliftDevice
| Study group | Role | What they receive |
|---|---|---|
| actimove sling | Active comparator | standard orthosis: actimove sling Receives: Device: actimove sling |
| shoulderlift | Experimental | newly developed orthosis: shoulderlift Receives: Device: shoulderlift |
| controle group | No intervention | no orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acromio - humeral distance
Measured: at 9 weeks after admission in the rehabilitation center
Acromio - humeral distance
Measured: at 3 weeks after admission in the rehabilitation center
Secondary outcomes (14)
Spasticity
Modified Ashworth Scale
Measured: at 9 weeks after admission in the rehabilitation center
Passive Range of motion
goniometric measurement
Measured: at 9 weeks after admission in the rehabilitation center
Trunk stability
Trunk Impairment Scale
Measured: at 9 weeks after admission in the rehabilitation center
comfort of the upper limb
Pain and comfort questionnaire
Measured: at 9 weeks after admission in the rehabilitation center
Balance
Measured: at 9 weeks after admission in the rehabilitation center
Gait characteristics
Measurement: Gait Rite
Measured: at 9 weeks after admission in the rehabilitation center
Spasticity
Modified Ashworth Scale
Measured: at 3 weeks after admission in the rehabilitation center
Passive Range of motion
goniometric measurement
Measured: at 3 weeks after admission in the rehabilitation center
Trunk stability
Trunk Impairment Scale
Measured: at 3 weeks after admission in the rehabilitation center
comfort of the upper limb
Pain and comfort questionnaire
Measured: at 3 weeks after admission in the rehabilitation center
Balance
Measured: at 3 weeks after admission in the rehabilitation center
Gait characteristics
Measurement: Gait Rite
Measured: at 3 weeks after admission in the rehabilitation center
Pain of the upper limb
Pain and comfort questionnaire
Measured: at 3 weeks after admission in the rehabilitation center
Pain of the upper limb
Pain and comfort questionnaire
Measured: at 9 weeks after admission in the rehabilitation center
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startJan 2014
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk Cambier, MD, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102269
- Sponsor's protocol ID
- EC/2013/991
- Acronym
- SinSbyS&Co
- Status last verified
- Dec 2022
- First submitted
- 17 Mar 2014
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Evaluation of the Effect of Shoulder Orthosis on the Subluxation in Stroke Patients
- ClinicalTrials.gov ID
- NCT02102269
- Acronym / sponsor ID
- SinSbyS&Co / EC/2013/991
- Conditions
- Stroke Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| actimove sling | Active comparator | Device: actimove slingstandard orthosis: actimove sling |
| shoulderlift | Experimental | Device: shoulderliftnewly developed orthosis: shoulderlift |
| controle group | No intervention | –no orthosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- First stroke
- Patients must be able to sit independently on a chair with arm support during 30 minutes
Key exclusion criteria (2 listed)
- No shoulder problems prior to stroke
- No severe cognitive problems that make it impossible to understand brief commands;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| actimove sling | Device | actimove sling |
| shoulderlift | Device | shoulderlift |
Primary outcome
Acromio - humeral distance
Time frame: at 9 weeks after admission in the rehabilitation center
Acromio - humeral distance
Time frame: at 3 weeks after admission in the rehabilitation center
14 secondary outcomes
Spasticity
Time frame: at 9 weeks after admission in the rehabilitation center
Passive Range of motion
Time frame: at 9 weeks after admission in the rehabilitation center
Trunk stability
Time frame: at 9 weeks after admission in the rehabilitation center
comfort of the upper limb
Time frame: at 9 weeks after admission in the rehabilitation center
Balance
Time frame: at 9 weeks after admission in the rehabilitation center
Gait characteristics
Time frame: at 9 weeks after admission in the rehabilitation center
Spasticity
Time frame: at 3 weeks after admission in the rehabilitation center
Passive Range of motion
Time frame: at 3 weeks after admission in the rehabilitation center
Trunk stability
Time frame: at 3 weeks after admission in the rehabilitation center
comfort of the upper limb
Time frame: at 3 weeks after admission in the rehabilitation center
Balance
Time frame: at 3 weeks after admission in the rehabilitation center
Gait characteristics
Time frame: at 3 weeks after admission in the rehabilitation center
Pain of the upper limb
Time frame: at 3 weeks after admission in the rehabilitation center
Pain of the upper limb
Time frame: at 9 weeks after admission in the rehabilitation center
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Cambier, MD, PhD principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing actimove sling and shoulderlift in people with Stroke Patients, run by University Hospital, Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acromio - humeral distance (time frame: at 9 weeks after admission in the rehabilitation center). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.